Post-Market Surveillance. 1. Member States shall establish post market surveillance systems to complement the implementation of the ASEAN Sectoral Mutual Recognition Arrangements and ASEAN Harmonised Regulatory Regimes and/or Directives.
2. The relevant authority that undertakes the post market surveillance system of the Member States shall take the necessary actions to ensure compliance of products placed in the market with the applicable ASEAN Sectoral Mutual Recognition Arrangements and ASEAN Harmonised Regulatory Regimes and/or Directives.
3. Member States should ensure that the necessary laws and technical infrastructure are in place to support post market surveillance systems.
4. The effectiveness of the post market surveillance systems shall be further enhanced through the establishment of Alert Systems among Member States.
Post-Market Surveillance. Post-market surveillance activities conducted by Telecommunication Certification Body (TCB) in accordance with ISO/IEC 17065 and 47 CFR Section 2.962(g)(2).
Post-Market Surveillance. As a part of the certification of the Product, the Client‘s Product may be selected for market surveillance purpose according to FCC post-market surveillance guidelines. If selected, Client shall cooperate with the INTERTEK TCB representative which requires the TCB to perform post-market surveillance activities based on type testing of products that the TCB has certified. If selected, Client agrees to reimburse INTERTEK for its services in accordance with the current fee schedule and any shipping expenses.
Post-Market Surveillance. Post-market surveillance will be investigated through complaint history, surgeon feedback, and/or clinical evaluations of both WMT and related competitor products.
Post-Market Surveillance. Both OCD and SNBTS shall ensure that the other party is kept informed of any relevant post-production experience relating to the Products which comes to the attention of either party. OCD shall immediately notify SNBTS of any relevant corrective actions or non-conformances relating to the Products. Both SNBTS and OCD shall adopt and operate appropriate systematic procedures to record and review post-marketing experiences with the Products and such as to comply with all legal requirements.
Post-Market Surveillance. 1. Member States shall establish post market surveillance systems to complement the implementation of the ASEAN Sectoral Mutual Recognition Arrangements and ASEAN Harmonised Regulatory Regimes and/or Directives.
2. The relevant authority that undertakes the post market surveillance system of the Member States shall take the necessary actions to ensure compliance of products placed in the market with the applicable ASEAN Sectoral Mutual Recognition Arrangements and ASEAN Harmonised Regulatory Regimes and/or Directives.
3. Member States should ensure that the necessary laws and technical infrastructure are in place to support post market surveillance systems.
4. The effectiveness of the post market surveillance systems shall be further enhanced through the establishment of Alert Systems among Member States.
1. Member States shall take all necessary measures to ensure implementation of all the ASEAN Sectoral Mutual Recognition Arrangements, ASEAN Harmonised Regulatory Regimes and the relevant provisions of this Agreement within the time frame stipulated in the aforesaid agreements and to ensure compliance with aforesaid harmonised requirements.
2. The following instruments, and any future instruments agreed by Member States to implement the provisions of this Agreement, shall form an integral part of this Agreement:
(a) ASEAN Framework Agreement on Mutual Recognition Arrangements;
(b) ASEAN Sectoral Mutual Recognition Arrangement for Electrical and Electronic Equipment;
(c) Agreement on the ASEAN Harmonized Electrical and Electronic Equipment (EEE) Regulatory Regime; and
(d) Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme.
3. The ASEAN Consultative Committee for Standards and Quality (ACCSQ) shall be responsible for:
(a) identifying and initiating sectoral MRAs;
(b) monitoring the effective implementation of the relevant provisions of this Agreement in respect of standards, technical regulations and conformity assessment procedures;
(c) providing support to the respective Joint Sectoral Committees when required; and
(d) collaborating with the ASEAN Secretariat to provide regular feedback on the implementation of this Agreement.
4. The ACCSQ shall provide support and co-operation under the relevant ASEAN Free Trade Agreements (FTAs) with Dialogue Partners, including capacity building and institutional strengthening programmes for Standards, Technical Regulations and Conformity Assessment Procedures Chapters in such ASEAN FTAs.
5. The ACCSQ shall t...
Post-Market Surveillance. ASEAN Member States shall ensure that post market surveillance is in place to handle early warning of any adverse events and/or other product safety issues that may occur and shall take appropriate measures to ensure consumer safety.
Post-Market Surveillance. Integrator will cooperate with Cisco and Cisco’s applicable authorized representative directly in matters of vigilance and post-market surveillance in accordance with the European Commission Guidelines On A Medical Devices Vigilance System. Integrator will further provide any such technical support on the usage of HealthPresence Products to the End User based on information supplied by Cisco. Integrator reporting should follow the current European Commission Guidelines On A Medical Devices Vigilance System.
Post-Market Surveillance. Member States shall ensure that post market surveillance is in place to handle early warning of any adverse events and/or other product safety issues that may occur and shall take appropriate measures to ensure consumer safety.
Post-Market Surveillance. Guidant will be responsible for any reportable events, such as patient death or injury, associated with the Products to the European authorities, and MTI will be solely responsible for any reportable events associated with the Products to the United States authorities; provided, however, that to the extent required by applicable law each party may report such events to the applicable authorities. Guidant will notify MTI of any such event within two (2) days after Guidant learns of such event. Each party agrees to provide the other party with any assistance required in connection with such activities, including without limitation access to the Product files.
