Common use of DESIGNATED CONFORMITY ASSESSMENT Clause in Contracts

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New Zealand’s legislative, regulatory and administrative requirements The designated conformity assessment bodies are: (Name and details to be inserted)(Further names to be added as required) The designated conformity assessment bodies are: (Name and details to be inserted) (Further names to be added as required) SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand For the conformity assessment bodies designated by the European Community — Ministry of Health — Belgium Ministère de la Santé publique, de l’Environnement et de l’Intégration sociale Ministerie van Volksgezondheid, Leefmilieu en Sociale Integratie — Denmark Sundhedsministeriet — Germany Bundesministerium für Gesundheit — Greece Υnουργsίο Υγsίας και Πρόνοιας Ministry of Health — Spain Ministerio xx Xxxxxxx y Consumo — France Ministère de l’emploi et de la solidarité Direction des hôpitaux Bureau des dispositifs médicaux Ministère de l’économie, des finances et de l’industrie Secrétariat d’État à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Health — Italy Ministero xxxxx Xxxxxx — Luxembourg Ministère de la Santé For the conformity assessment bodies designated by New Zealand For the conformity assessment bodies designated by the European Community — Netherlands Staat der Nederlanden — Austria Bundesministerium für Arbeit, Gesundheit und Soziales — Portugal Ministério da Saúde — Finland Sosiaali- ja terveysministeriö/ Social- och hälsovårdsministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom Department of Health SECTION IV

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New Zealand’s legislative, regulatory and administrative requirements The designated conformity assessment bodies are: ([Name and details to be inserted)(Further inserted][Further names to be added as required) ] The designated conformity assessment bodies are: ([Name and details to be inserted) (] [Further names to be added as required) ] SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand For the conformity assessment bodies designated by the European Community Under the authority of the New Zealand Government:(a) For Certification Bodies: — Ministry The Joint Accreditation System of Health Australia and New Zealand (XXX-ANZ) (b) For Testing Laboratories and Inspection Bodies: — The Testing Laboratory Registration Council of New Zealand — Belgium Ministère de la Santé publique, de l’Environnement et de l’Intégration sociale des Affaires Economiques Ministerie van Volksgezondheid, Leefmilieu en Sociale Integratie Economische Zaken — Denmark Sundhedsministeriet For telecommunications equipment: Telestyrelsen For other equipment: Danmarks Elektriske Materielkontrol (XXXXX) — Germany Bundesministerium für Gesundheit Wirtschaft — Greece Υnουργsίο Υγsίας Μsuα ορω' ν και Πρόνοιας Εnικοινωνιω' ν Ministry of Health Transport and Communications — Spain For telecommunications equipment: Ministerio xx Xxxxxxx de Fomento for other equipment: Ministerio de Industria y Consumo Energía — France Ministère de l’emploi et de la solidarité Direction des hôpitaux Bureau des dispositifs médicaux Ministère de l’économie, des finances et de l’industrie Secrétariat d’État à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Health Transport, Energy and Communications — Italy Ministero xxxxx Xxxxxx dell’Industria, del Commercio e dell’Artigianato — Luxembourg Ministère des transports — Netherlands Ministerie van Verkeer en Waterstaat — Austria For telecommunications equipment: Bundesministerium für Wissenschaft und Verkehr For other equipment: Bundesministerium für Wirtschaftliche Angelegenheiten — Portugal Under the authority of the Government of Portugal: Instituto das Comunicações de la Santé Portugal — Finland For telecommunications equipment: Liikenneministeriö/Trafikministeriet For other equipment: Kauppa- ja teollisuusministeriö/ Handels- och industriministeriet For the conformity assessment bodies designated by New Zealand For the conformity assessment bodies designated by the European Community — Netherlands Staat der Nederlanden — Austria Bundesministerium für Arbeit, Gesundheit und Soziales — Portugal Ministério da Saúde — Finland Sosiaali- ja terveysministeriö/ Social- och hälsovårdsministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom UK Department of Health SECTION IVTrade and Industry

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand Australia to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New ZealandAustralia’s legislative, regulatory and administrative requirements The designated conformity assessment bodies are: ([Name and details to be inserted)(Further inserted][Note: Further names to be added as required) ] The designated conformity assessment bodies are: ([Name and details to be inserted) (] [Note: Further names to be added as required) ] SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community Under the authority of the Government of Australia: (a) For certification bodies: — Ministry The Joint Accreditation System of Health Australia and New Zealand (XXX-ANZ), and (b) For testing laboratories and inspection bodies: — The National Association of Testing Authorities, Australia (NATA) — Belgium Ministère de la Santé publique, de l’Environnement et de l’Intégration sociale des affaires économiques Ministerie van Volksgezondheid, Leefmilieu en Sociale Integratie Economische Zaken — Denmark Sundhedsministeriet Boligministeriet — Germany Bundesministerium für Gesundheit Arbeit und Sozialordnung — Greece Υnουργsίο Υγsίας και Πρόνοιας Zπoνργεío Ανáπινκης Ministry of Health Development — Spain Ministerio xx Xxxxxxx de Industria y Consumo Energía — France Ministère de l’emploi et de la solidarité Direction des hôpitaux Bureau des dispositifs médicaux Ministère de l’économie, des finances et de l’industrie Secrétariat d’État à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Health Enterprise and Employment — Italy Ministero xxxxx Xxxxxx dell’Industria, del Commercio e dell’Artigianato — Luxembourg Ministère de la Santé des transports — Netherlands Staat der Nederlanden — Austria Bundesministerium für wirtschaftliche Angelegenheiten For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community — Netherlands Staat der Nederlanden — Austria Bundesministerium für Arbeit, Gesundheit und Soziales — Portugal Ministério Under the authority of the Government of Portugal: Instituto Português da Saúde Qualidade — Finland Sosiaali- Kauppa- ja terveysministeriö/ Social- teollisuusministeriö/ Handels- och hälsovårdsministeriet industriministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom UK Department of Health SECTION IVTrade and Industry

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand Australia to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New ZealandAustralia’s legislative, regulatory and administrative requirements The designated conformity assessment bodies are: ([Name and details to be inserted)(Further inserted][Further names to be added as required) ] The designated conformity assessment bodies are: ([Name and details to be inserted) (] [Further names to be added as required) ] SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by Australia For the conformity assessment bodies designated by the European Community Under the authority of the Government of Australia:(a) For certification bodies: — The Joint Accreditation System of Australia and New Zealand (XXX-ANZ) (b) For testing laboratories and inspection bodies: — The National Association of Testing Authorities, Australia (NATA) — Belgium Ministère des affaires economiques Ministerie von Economische Zaken — Denmark For telecommunication equipment: Telestyrelsen For other equipment: Danmarks Elektriske Materielkontrol (XXXXX) For the conformity assessment bodies designated by Australia For the conformity assessment bodies designated by the European Community — Ministry of Health — Belgium Ministère de la Santé publique, de l’Environnement et de l’Intégration sociale Ministerie van Volksgezondheid, Leefmilieu en Sociale Integratie — Denmark Sundhedsministeriet — Germany Bundesministerium für Gesundheit Wirtschaft — Greece Υnουργsίο Υγsίας Υπoϊργειo Μεταeoρω' ν και Πρόνοιας Επικoινωνιω'ν Ministry of Health Transport and Communications — Spain For telecommunication equipment: Ministerio xx Xxxxxxx de Fomento for other equipment: Ministerio de Industria y Consumo Energía — France Ministère de l’emploi et de la solidarité Direction des hôpitaux Bureau des dispositifs médicaux Ministère de l’économie, des finances et de l’industrie Secrétariat d’État à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Health Transport, Energy and Communications — Italy Ministero xxxxx Xxxxxx dell’Industria, del Commercio e dell’Artigianato — Luxembourg Ministère de la Santé For the conformity assessment bodies designated by New Zealand For the conformity assessment bodies designated by the European Community des transports — Netherlands Staat der Nederlanden De Minister van Verkeer en Waterstaat — Austria For telecommunication equipment: Bundesministerium für Arbeit, Gesundheit Wissenschaft und Soziales Verkehr For other equipment: Bundesministerium für wirtschaftliche Angelegenheiten — Portugal Ministério da Saúde Under the authority of the Government of Portugal: Instituto das Comunicações de Portugal — Finland Sosiaali- For telecommunication equipment: Liikenneministeriö/Trafikministeriet For other equipment: Kauppa- ja terveysministeriö/ Social- teollisuusministeriö/ Handels- och hälsovårdsministeriet industriministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom UK Department of Health SECTION IVTrade and Industry

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand Australia to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New ZealandAustralia’s legislative, regulatory and administrative requirements The designated Therapeutic Goods Administration of the Department of Health and Family Services, in respect of the conformity assessment bodies are: (Name procedures required under the Community legislation cited in Section I, for all medical devices and details for all modules for the various phases of the conformity assessment procedures applicable to be inserted)(Further names to be added as required) such devices The designated conformity assessment bodies are: ([Name and details to be inserted) (] [Further names to be added as required) ] SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community — Ministry Department of Health and Family Services — Belgium Ministère de la Santé santé publique, de l’Environnement l’environnement et de l’Intégration l’intégration sociale Ministerie van Volksgezondheid, Leefmilieu en Sociale Integratie — Denmark Sundhedsministeriet — Germany Bundesministerium für Gesundheit — Greece Υnουργsίο Υγsίας και Πρόνοιας Υπoϊργεío Υγεíας καí πρóνoιας Ministry of Health — Spain Ministerio xx Xxxxxxx y Consumo — France Ministère de l’emploi et de la solidarité Direction des hôpitaux Bureau des dispositifs médicaux Ministère de l’économie, des finances et de l’industrie Secrétariat d’État à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Health — Italy Ministero xxxxx Xxxxxx — Luxembourg Ministère de la Santé For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community — Luxembourg Ministère de la santé — Netherlands Staat der Nederlanden — Austria Bundesministerium für Arbeit, Gesundheit und Soziales — Portugal Ministério da Saúde de saúde — Finland Sosiaali- ja terveysministeriö/ Social- och hälsovårdsministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom Kingdom Department of Health SECTION IV

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand Australia to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New ZealandAustralia’s legislative, regulatory and administrative requirements The designated conformity assessment bodies are: ([Name and details to be inserted)(Further inserted][Further names to be added as required) ] The designated conformity assessment bodies are: ([Name and details to be inserted) (] [Further names to be added as required) ] SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by Australia For the conformity assessment bodies designated by the European Community Under the authority of the Government of Australia:(a) For certification bodies: — The Joint Accreditation System of Australia and New Zealand (XXX-ANZ)(b) For testing laboratories and inspection bodies: — The National Association of Testing Authorities, Australia (NATA) — Belgium Ministère des affaires economiques Ministerie von Economische Zaken — Denmark For telecommunication equipment: Telestyrelsen For other equipment: Danmarks Elektriske Materielkontrol (XXXXX) For the conformity assessment bodies designated by Australia For the conformity assessment bodies designated by the European Community — Ministry of Health — Belgium Ministère de la Santé publique, de l’Environnement et de l’Intégration sociale Ministerie van Volksgezondheid, Leefmilieu en Sociale Integratie — Denmark Sundhedsministeriet — Germany Bundesministerium für Gesundheit Wirtschaft — Greece Υnουργsίο Υγsίας Υnο3ργsιο Μsτα ορω' ν και Πρόνοιας Εnικοινωνιω' ν Ministry of Health Transport and Communications — Spain For telecommunication equipment: Ministerio xx Xxxxxxx de Fomento for other equipment: Ministerio de Industria y Consumo Energía — France Ministère de l’emploi et de la solidarité Direction des hôpitaux Bureau des dispositifs médicaux Ministère de l’économie, des finances et de l’industrie Secrétariat d’État à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Health Transport, Energy and Communications — Italy Ministero xxxxx Xxxxxx dell’Industria, del Commercio e dell’Artigianato — Luxembourg Ministère de la Santé For the conformity assessment bodies designated by New Zealand For the conformity assessment bodies designated by the European Community des transports — Netherlands Staat der Nederlanden De Minister van Verkeer en Waterstaat — Austria For telecommunication equipment: Bundesministerium für Arbeit, Gesundheit Wissenschaft und Soziales Verkehr For other equipment: Bundesministerium für wirtschaftliche Angelegenheiten — Portugal Ministério da Saúde Under the authority of the Government of Portugal: Instituto das Comunicações de Portugal — Finland Sosiaali- For telecommunication equipment: Liikenneministeriö/Trafikministeriet For other equipment: Kauppa- ja terveysministeriö/ Social- teollisuusministeriö/ Handels- och hälsovårdsministeriet industriministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom UK Department of Health SECTION IVTrade and Industry

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand Australia to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New ZealandAustralia’s legislative, regulatory and administrative requirements Federal Office of Road Safety XX Xxx 000 Xxxxxxxx XXX 0000 Xxxxxxxxx The designated conformity assessment bodies are: (Name and details to be inserted)(Further names to be added as required) The designated conformity assessment bodies are: ([Name and details to be inserted) (] [Further names to be added as required) SECTION III THE ] AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY OF ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community — Ministry The Administrator of Health Vehicle Standards delegated by the Australian Minister for Transport under the provisions of the Motor Vehicle Standards Xxx 0000 — Belgium Ministère de la Santé publique, de l’Environnement des communications et de l’Intégration sociale l’infrastructure Ministerie van Volksgezondheid, Leefmilieu Verkeer en Sociale Integratie Infrastructur — Denmark Sundhedsministeriet Færdselsstyrelsen — Germany Bundesministerium für Gesundheit Verkehr — Greece Υnουργsίο Υγsίας και Πρόνοιας Υπoυργεío Μεταeoρω'ν Ministry of Health Transport — Spain Ministerio xx Xxxxxxx de Industria y Consumo Energía — France Ministère d’équipment, des transports et du logement Direction de l’emploi la sécurité et de la solidarité Direction des hôpitaux Bureau des dispositifs médicaux Ministère de l’économie, des finances et de l’industrie Secrétariat d’État à l’industrie Direction générale des stratégies industrielles circulation routière Sous direction de la qualité et de la normalisation réglementation technique des véhicules — Ireland Department of Health Enterprise and Employment — Italy Ministero xxxxx Xxxxxx dei Trasporti — Luxembourg Ministère de la Santé For the conformity assessment bodies designated by New Zealand For the conformity assessment bodies designated by the European Community des transports — Netherlands Staat der Nederlanden Dienst Wegverkeer (RDW Centrum voor Voertuigtechniek en Informatie) — Austria Bundesministerium für Arbeit, Gesundheit Wissenschaft und Soziales Verkehr — Portugal Ministério da Saúde Direcção-Geral de Viação — Finland Sosiaali- ja terveysministeriö/ Social- och hälsovårdsministeriet Liikenneministeriö/Trafikministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom Department of Health UK Vehicle Certification Agency SECTION IV

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand to assess products against the European Community’s 's legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New Zealand’s 's legislative, regulatory and administrative requirements The designated conformity assessment bodies are: (Name and details to be inserted)(Further names to be added as required) The designated conformity assessment bodies are: ([Name and details to be inserted) (] [Name and details to be inserted] [Further names to be added as required) ] [Further names to be added as required] ▼B SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand For the conformity assessment bodies designated by the European Community Under the authority of the New Zealand Government: (a) For Certification Bodies: — Ministry The Joint Accreditation System of Health Australia and New Zealand (XXX-ANZ) (b) For Testing Laboratories and Inspection Bodies: — The Testing Laboratory Regis- tration Council of New Zealand — Belgium Ministère de la Santé publique, de l’Environnement et de l’Intégration sociale des Affaires Economiques Ministerie van Volksgezondheid, Leefmilieu en Sociale Integratie Economische Zaken — Denmark Sundhedsministeriet For telecommunications equipment: Telestyrelsen For other equipment: Danmarks Elektriske Materielkontrol (XXXXX) — Germany Bundesministerium für Gesundheit Wirtschaft — Greece Υnουργsίο Υγsίας Υπουργείο Μεταφορών και Πρόνοιας Επι- κοινωνιών Ministry of Health Transport and Commu- nications — Spain For telecommunications equipment: Ministerio xx Xxxxxxx de Fomento for other equipment: Ministerio de Industria y Consumo Energía — France Ministère de l’emploi et de la solidarité Direction des hôpitaux Bureau des dispositifs médicaux Ministère de l’économie, des finances et de l’industrie Secrétariat d’État à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Health Transport, Energy and Communications — Italy Ministero xxxxx Xxxxxx dell'Industria, del Commercio e dell'Artigianato — Luxembourg Ministère de la Santé des transports — Netherlands Ministerie van Verkeer en Waterstaat — Austria For telecommunications equipment: Bundesministerium für Wissenschaft und Verkehr For other equipment: Bundesministerium für Wirtschaftliche Angelegenheiten ▼B For the conformity assessment bodies designated by New Zealand For the conformity assessment bodies designated by the European Community — Netherlands Staat der Nederlanden — Austria Bundesministerium für Arbeit, Gesundheit und Soziales — Portugal Ministério da Saúde Under the authority of the Government of Portugal: Instituto das Comunicações de Portugal — Finland Sosiaali- For telecommunications equipment: Liikenneministeriö/Trafikministeriet For other equipment: Kauppa- ja terveysministeriö/ Social- teollisuusministeriö/ Handels- och hälsovårdsministeriet industriministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom UK Department of Health Trade and Industry SECTION IV

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand Australia to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New ZealandAustralia’s legislative, regulatory and administrative requirements The designated conformity assessment bodies are: (Name and details to be inserted)(Further names to be added as required) The designated conformity assessment bodies are: ([Name and details to be inserted) (] [Name and details to be inserted] [Further names and details to be added as required) ] [Further names and details to be added as required] SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community Commission Under the authority of the Government of Australia: (a) For certification bodies: — Ministry the Joint Accreditation System of Health Australia and New Zealand (XXX-ANZ) (b) For testing laboratories and inspection bodies: — The National Association of Testing Authorities, Australia (NATA) — Belgium Ministère de la Santé publique, de l’Environnement et de l’Intégration sociale l’économie Ministerie van Volksgezondheid, Leefmilieu en Sociale Integratie Economie — Denmark Sundhedsministeriet Direktoratet für Arbejdstilsynet — Germany Bundesministerium für Gesundheit Arbeit und Sozialordnung — Greece Υnουργsίο Υγsίας και Πρόνοιας Υπoυργεío Ανáπτυκης Ministry of Health Development — Spain Ministerio xx Xxxxxxx de Industria y Consumo Energía — France Ministère de l’emploi et de la solidarité Direction des hôpitaux Bureau des dispositifs médicaux relations du travail Xxxxxx XX0 Ministère de l’économie, des finances et de l’industrie Secrétariat d’État d’Etat à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Health Enterprise and Employment — Italy Ministero xxxxx Xxxxxx dell’Industria, del Commercio e dell’Artigianato — Luxembourg Ministère de la Santé des transports For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community Commission — Netherlands Staat der Nederlanden — Austria Bundesministerium für Arbeit, Gesundheit und Soziales wirtschaftliche Angelegenheiten — Portugal Ministério Under the authority of the Government of Portugal: Instituto Português da Saúde Qualidade — Finland Sosiaali- ja terveysministeriö/ Social- och hälsovårdsministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom UK Department of Health SECTION IVTrade and Industry

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand Australia to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New ZealandAustralia’s legislative, regulatory and administrative requirements The designated conformity assessment bodies are: ([Name and details to be inserted)(Further inserted][Note: Further names to be added as required) ] The designated conformity assessment bodies are: ([Name and details to be inserted) (] [Note: Further names to be added as required) ] SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community Under the authority of the Government of Australia: (a) For certification bodies: — Ministry The Joint Accreditation System of Health Australia and New Zealand (XXX-ANZ), and (b) For testing laboratories and inspection bodies: — The National Association of Testing Authorities, Australia (NATA). — Belgium Ministère de la Santé publique, de l’Environnement Institut belge des services postaux et de l’Intégration sociale Ministerie van Volksgezondheid, Leefmilieu des télécommunications Belgisch instituut voor postdiensten en Sociale Integratie telecommunicatie — Denmark Sundhedsministeriet Telestyrelsen — Germany Bundesministerium für Gesundheit Wirtschaft — Greece Υnουργsίο Υγsίας Υnο3ργsίο Μsτα ορω' ν και Πρόνοιας Εnικοινωνιω' ν Ministry of Health Transport and Communications — Spain Ministerio xx Xxxxxxx y Consumo de Fomento — France Ministère de l’emploi l’économie, des finances et de la solidarité l’industrie Secrétariat d’État à l’industrie Direction des hôpitaux Bureau postes et télécommunications Service des dispositifs médicaux télécommunications Ministère de l’économie, des finances et de l’industrie Secrétariat d’État à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Health Transport, Energy and Communications — Italy Ministero xxxxx Xxxxxx — Luxembourg Ministère de la Santé Ispettorato Generale TLC For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community — Luxembourg Administration des postes et télécommunications — Netherlands Staat der Nederlanden De Minister van Verkeer en Waterstaat — Austria Bundesministerium für Arbeit, Gesundheit Wissenschaft und Soziales Verkehr — Portugal Ministério da Saúde Instituto das Comunicações de Portugal — Finland Sosiaali- ja terveysministeriö/ Social- och hälsovårdsministeriet Liikenneministeriö/Trafikministeriet Telehallintokeskus/Teleförvaltningscentralen — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom UK Department of Health SECTION IVTrade and Industry

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand Australia to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New ZealandAustralia’s legislative, regulatory and administrative requirements The designated conformity assessment bodies are: (Name and details to be inserted)(Further names to be added as required) The designated conformity assessment bodies are: (Name [Names and details to be inserted) (] [Names and details to be inserted] [Note: Further names and details to be added as required) ] [Note: Further names and details to be added as required] SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community Commission Under the authority of the Government of Australia: (a) For certification bodies: — Ministry The Joint Accreditation System of Health Australia and New Zealand (XXX-ANZ) (b) For testing laboratories and inspection bodies: — The National Association of Testing Authorities, Australia (NATA) — Belgium Ministère de la Santé publique, de l’Environnement et de l’Intégration sociale l’économie Ministerie van Volksgezondheid, Leefmilieu en Sociale Integratie Economie — Denmark Sundhedsministeriet Direktoratet for Arbejdstilsynet — Germany Bundesministerium für Gesundheit Arbeit und Sozialordnung — Greece Υnουργsίο Υγsίας και Πρόνοιας Υπoυργεío Ανáπτυκης Ministry of Health Development — Spain Ministerio xx Xxxxxxx de Industria y Consumo Energía For the conformity assessment bodies designated by Australia For the conformity assessment bodies designated by the European Commission — France Ministère de l’emploi et de la solidarité Direction des hôpitaux Bureau des dispositifs médicaux Ministère de l’économie, des finances et de l’industrie Secrétariat d’État d’Etat à l’industrie Direction de l’action régionale de de la petite et moyenne industrie Sous direction de la sécurité industrielle Ministère de l’économie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Health Enterprise and Employment — Italy Ministero xxxxx Xxxxxx dell’Industria, del Commercio e dell’Artigianato — Luxembourg Ministère de la Santé For the conformity assessment bodies designated by New Zealand For the conformity assessment bodies designated by the European Community des transports — Netherlands Staat der Nederlanden — Austria Bundesministerium für Arbeit, Gesundheit und Soziales wirtschaftliche Angelegenheiten — Portugal Ministério Under the authority of the Government of Portugal: Instituto Português da Saúde Qualidade — Finland Sosiaali- Kauppa- ja terveysministeriö/ Social- teollisuusministeriö/Handels- och hälsovårdsministeriet industriministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom UK Department of Health SECTION IVTrade and Industry PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES The procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Community’s requirements The procedures to be followed by the European Community in designating conformity assessment bodies to assess products against Australia’s requirements The conformity assessment bodies listed in Section II will meet the requirements of the Directives listed in Section I, taking into account Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives, and are designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through: 1. Where the laws and regulations listed in Section I make compliance with AS 3920.1 and Australian standards for pressure equipment mandatory, the conformity assessment bodies listed in Section II are designated by the designating authorities specified in Section III in accordance with the following criteria: (i) Design verification bodies complying with AS 3920.1 and (i) Product certification bodies operating according to the requirements of EN 45011 or ISO Guides 28 and 40, and either: (a) operating within a quality system meeting the requirements of ISO 9001 and certified by a quality systems certification body operating according to the requirements of ISO Guide 62 or EN 45012, and either:

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand Australia to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New ZealandAustralia’s legislative, regulatory and administrative requirements The designated conformity assessment bodies are: ([Name and details to be inserted)(Further inserted][Note: Further names to be added as required) ] The designated conformity assessment bodies are: ([Name and details to be inserted) (] [Note: Further names to be added as required) ] SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community Under the authority of the Government of Australia: (a) For certification bodies: — Ministry The Joint Accreditation System of Health Australia and New Zealand (XXX-ANZ), and (b) For testing laboratories and inspection bodies: — The National Association of Testing Authorities, Australia (NATA). — Belgium Ministère de la Santé publique, de l’Environnement Institut belge des services postaux et de l’Intégration sociale Ministerie van Volksgezondheid, Leefmilieu des télécommunications Belgisch instituut voor postdiensten en Sociale Integratie telecommunicatie — Denmark Sundhedsministeriet Telestyrelsen — Germany Bundesministerium für Gesundheit Wirtschaft — Greece Υnουργsίο Υγsίας Υπoϊργεío Μεταeoρω' ν και Πρόνοιας Επικoινωνιω'ν Ministry of Health Transport and Communications — Spain Ministerio xx Xxxxxxx y Consumo de Fomento — France Ministère de l’emploi l’économie, des finances et de la solidarité l’industrie Secrétariat d’État à l’industrie Direction des hôpitaux Bureau postes et télécommunications Service des dispositifs médicaux télécommunications Ministère de l’économie, des finances et de l’industrie Secrétariat d’État à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Health Transport, Energy and Communications — Italy Ministero xxxxx Xxxxxx — Luxembourg Ministère de la Santé Ispettorato Generale TLC For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community — Luxembourg Administration des postes et télécommunications — Netherlands Staat der Nederlanden De Minister van Verkeer en Waterstaat — Austria Bundesministerium für Arbeit, Gesundheit Wissenschaft und Soziales Verkehr — Portugal Ministério da Saúde Instituto das Comunicações de Portugal — Finland Sosiaali- ja terveysministeriö/ Social- och hälsovårdsministeriet Liikenneministeriö/Trafikministeriet Telehallintokeskus/Teleförvaltningscentralen — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom UK Department of Health SECTION IVTrade and Industry

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand Australia to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New ZealandAustralia’s legislative, regulatory and administrative requirements The designated conformity assessment bodies are: ([Name and details to be inserted)(Further inserted][Further names and details to be added as required) ] The designated conformity assessment bodies are: ([Name and details to be inserted) (] [Further names and details to be added as required) ] SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community Commission Under the authority of the Government of Australia: (a) For certification bodies: — Ministry the Joint Accreditation System of Health Australia and New Zealand (XXX-ANZ) (b) For testing laboratories and inspection bodies: — The National Association of Testing Authorities, Australia (NATA) — Belgium Ministère de la Santé publique, de l’Environnement et de l’Intégration sociale l’économie Ministerie van Volksgezondheid, Leefmilieu en Sociale Integratie Economie — Denmark Sundhedsministeriet Direktoratet für Arbejdstilsynet — Germany Bundesministerium für Gesundheit Arbeit und Sozialordnung — Greece Υnουργsίο Υγsίας και Πρόνοιας Υnoυργsío Ανánuυ3ης Ministry of Health Development — Spain Ministerio xx Xxxxxxx de Industria y Consumo Energía — France Ministère de l’emploi et de la solidarité Direction des hôpitaux Bureau des dispositifs médicaux relations du travail Xxxxxx XX0 Ministère de l’économie, des finances et de l’industrie Secrétariat d’État d’Etat à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Health Enterprise and Employment — Italy Ministero xxxxx Xxxxxx dell’Industria, del Commercio e dell’Artigianato — Luxembourg Ministère de la Santé des transports For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community Commission — Netherlands Staat der Nederlanden — Austria Bundesministerium für Arbeit, Gesundheit und Soziales wirtschaftliche Angelegenheiten — Portugal Ministério Under the authority of the Government of Portugal: Instituto Português da Saúde Qualidade — Finland Sosiaali- ja terveysministeriö/ Social- och hälsovårdsministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom UK Department of Health SECTION IVTrade and Industry

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand Australia to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New ZealandAustralia’s legislative, regulatory and administrative requirements The designated conformity assessment bodies are: ([Name and details to be inserted)(Further inserted][Note: Further names to be added as required) ] The designated conformity assessment bodies are: ([Name and details to be inserted) (] [Note: Further names to be added as required) ] SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community Under the authority of the Government of Australia: (a) For certification bodies: — Ministry The Joint Accreditation System of Health Australia and New Zealand (XXX-ANZ), and (b) For testing laboratories and inspection bodies: — The National Association of Testing Authorities, Australia (NATA) — Belgium Ministère de la Santé publique, de l’Environnement et de l’Intégration sociale des affaires économiques Ministerie van Volksgezondheid, Leefmilieu en Sociale Integratie Economische Zaken — Denmark Sundhedsministeriet Boligministeriet — Germany Bundesministerium für Gesundheit Arbeit und Sozialordnung — Greece Υnουργsίο Υγsίας και Πρόνοιας Znoνργsío Ανánιν3ης Ministry of Health Development — Spain Ministerio xx Xxxxxxx de Industria y Consumo Energía — France Ministère de l’emploi et de la solidarité Direction des hôpitaux Bureau des dispositifs médicaux Ministère de l’économie, des finances et de l’industrie Secrétariat d’État à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Health Enterprise and Employment — Italy Ministero xxxxx Xxxxxx dell’Industria, del Commercio e dell’Artigianato — Luxembourg Ministère de la Santé des transports — Netherlands Staat der Nederlanden — Austria Bundesministerium für wirtschaftliche Angelegenheiten For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community — Netherlands Staat der Nederlanden — Austria Bundesministerium für Arbeit, Gesundheit und Soziales — Portugal Ministério Under the authority of the Government of Portugal: Instituto Português da Saúde Qualidade — Finland Sosiaali- Kauppa- ja terveysministeriö/ Social- teollisuusministeriö/ Handels- och hälsovårdsministeriet industriministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom UK Department of Health SECTION IVTrade and Industry

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand Australia to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New ZealandAustralia’s legislative, regulatory and administrative requirements Federal Office of Road Safety XX Xxx 000 Xxxxxxxx XXX 0000 Xxxxxxxxx The designated conformity assessment bodies are: (Name and details to be inserted)(Further names to be added as required) The designated conformity assessment bodies are: ([Name and details to be inserted) (] [Further names to be added as required) SECTION III THE ] AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY OF ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community — Ministry The Administrator of Health Vehicle Standards delegated by the Australian Minister for Transport under the provisions of the Motor Vehicle Standards Xxx 0000 — Belgium Ministère de la Santé publique, de l’Environnement des communications et de l’Intégration sociale l’infrastructure Ministerie van Volksgezondheid, Leefmilieu Verkeer en Sociale Integratie Infrastructur — Denmark Sundhedsministeriet Færdselsstyrelsen — Germany Bundesministerium für Gesundheit Verkehr — Greece Υnουργsίο Υγsίας και Πρόνοιας Υnoυργsío Μsuα oρω' ν Ministry of Health Transport — Spain Ministerio xx Xxxxxxx de Industria y Consumo Energía — France Ministère d’équipment, des transports et du logement Direction de l’emploi la sécurité et de la solidarité Direction des hôpitaux Bureau des dispositifs médicaux Ministère de l’économie, des finances et de l’industrie Secrétariat d’État à l’industrie Direction générale des stratégies industrielles circulation routière Sous direction de la qualité et de la normalisation réglementation technique des véhicules — Ireland Department of Health Enterprise and Employment — Italy Ministero xxxxx Xxxxxx dei Trasporti — Luxembourg Ministère de la Santé For the conformity assessment bodies designated by New Zealand For the conformity assessment bodies designated by the European Community des transports — Netherlands Staat der Nederlanden Dienst Wegverkeer (RDW Centrum voor Voertuigtechniek en Informatie) — Austria Bundesministerium für Arbeit, Gesundheit Wissenschaft und Soziales Verkehr — Portugal Ministério da Saúde Direcção-Geral de Viação — Finland Sosiaali- ja terveysministeriö/ Social- och hälsovårdsministeriet Liikenneministeriö/Trafikministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom Department of Health UK Vehicle Certification Agency SECTION IV

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand Australia to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New ZealandAustralia’s legislative, regulatory and administrative requirements The designated Therapeutic Goods Administration of the Department of Health and Family Services, in respect of the conformity assessment bodies are: (Name procedures required under the Community legislation cited in Section I, for all medical devices and details for all modules for the various phases of the conformity assessment procedures applicable to be inserted)(Further names to be added as required) such devices The designated conformity assessment bodies are: ([Name and details to be inserted) (] [Further names to be added as required) ] SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community — Ministry Department of Health and Family Services — Belgium Ministère de la Santé santé publique, de l’Environnement l’environnement et de l’Intégration l’intégration sociale Ministerie van Volksgezondheid, Leefmilieu en Sociale Integratie — Denmark Sundhedsministeriet — Germany Bundesministerium für Gesundheit — Greece Υnουργsίο Υnο3ργsίο Υγsίας και Πρόνοιας καί nρόνοιας Ministry of Health — Spain Ministerio xx Xxxxxxx y Consumo — France Ministère de l’emploi et de la solidarité Direction des hôpitaux Bureau des dispositifs médicaux Ministère de l’économie, des finances et de l’industrie Secrétariat d’État à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Health — Italy Ministero xxxxx Xxxxxx — Luxembourg Ministère de la Santé For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community — Luxembourg Ministère de la santé — Netherlands Staat der Nederlanden — Austria Bundesministerium für Arbeit, Gesundheit und Soziales — Portugal Ministério da Saúde de saúde — Finland Sosiaali- ja terveysministeriö/ Social- och hälsovårdsministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom Kingdom Department of Health SECTION IV

DESIGNATED CONFORMITY ASSESSMENT. BODIES The conformity assessment bodies designated by New Zealand Australia to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New ZealandAustralia’s legislative, regulatory and administrative requirements The designated conformity assessment bodies are: (Name [Names and details to be inserted)(Further inserted][Note: Further names and details to be added as required) ] The designated conformity assessment bodies are: (Name [Names and details to be inserted) (] [Note: Further names and details to be added as required) ] SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community Commission Under the authority of the Government of Australia: (a) For certification bodies: — Ministry The Joint Accreditation System of Health Australia and New Zealand (XXX-ANZ) (b) For testing laboratories and inspection bodies: — The National Association of Testing Authorities, Australia (NATA) — Belgium Ministère de la Santé publique, de l’Environnement et de l’Intégration sociale l’économie Ministerie van Volksgezondheid, Leefmilieu en Sociale Integratie Economie — Denmark Sundhedsministeriet Direktoratet for Arbejdstilsynet — Germany Bundesministerium für Gesundheit Arbeit und Sozialordnung — Greece Υnουργsίο Υγsίας και Πρόνοιας Υnoυργsío Ανánuυ3ης Ministry of Health Development — Spain Ministerio xx Xxxxxxx de Industria y Consumo Energía For the conformity assessment bodies designated by Australia For the conformity assessment bodies designated by the European Commission — France Ministère de l’emploi et de la solidarité Direction des hôpitaux Bureau des dispositifs médicaux Ministère de l’économie, des finances et de l’industrie Secrétariat d’État d’Etat à l’industrie Direction de l’action régionale de de la petite et moyenne industrie Sous direction de la sécurité industrielle Ministère de l’économie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Health Enterprise and Employment — Italy Ministero xxxxx Xxxxxx dell’Industria, del Commercio e dell’Artigianato — Luxembourg Ministère de la Santé For the conformity assessment bodies designated by New Zealand For the conformity assessment bodies designated by the European Community des transports — Netherlands Staat der Nederlanden — Austria Bundesministerium für Arbeit, Gesundheit und Soziales wirtschaftliche Angelegenheiten — Portugal Ministério Under the authority of the Government of Portugal: Instituto Português da Saúde Qualidade — Finland Sosiaali- Kauppa- ja terveysministeriö/ Social- teollisuusministeriö/Handels- och hälsovårdsministeriet industriministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kongdom UK Department of Health SECTION IVTrade and Industry PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES The procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Community’s requirements The procedures to be followed by the European Community in designating conformity assessment bodies to assess products against Australia’s requirements The conformity assessment bodies listed in Section II will meet the requirements of the Directives listed in Section I, taking into account Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives, and are designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through: 1. Where the laws and regulations listed in Section I make compliance with AS 3920.1 and Australian standards for pressure equipment mandatory, the conformity assessment bodies listed in Section II are designated by the designating authorities specified in Section III in accordance with the following criteria: (i) Design verification bodies complying with AS 3920.1 and (i) Product certification bodies operating according to the requirements of EN 45011 or ISO Guides 28 and 40, and either: (a) operating within a quality system meeting the requirements of ISO 9001 and certified by a quality systems certification body operating according to the requirements of ISO Guide 62 or EN 45012, and either: