Common use of Listing under the Medical Device Administrative Control System Clause in Contracts

Listing under the Medical Device Administrative Control System. 7.1 Currently, there is no specific legislative control over the importation and sale of medical devices in Hong Kong. Pending the enactment of legislation, the Department of Health of the Government of Hong Kong SAR (“DH”) has set up the “Medical Device Administrative Control System” (“MDACS”) with the following features: (a) listing system for medical devices, under which manufacturers and importers of medical devices could voluntarily list their medical devices with the DH; and (b) an adverse incident reporting system, through which the manufacturers, importers, users, and the general public could report adverse incidents to the DH for evaluation to reduce the likelihood of, or to prevent repetition of adverse incidents, or alleviate consequences of such repetition. 7.2 The MDACS is run by the Medical Device Control Office under DH (“MDCO”). 7.3 The Hospital Authority supports the MDACS’s objective to safeguard patient safety, and has included in this Invitation to Quote the requirement for the Seller to commit to the submission of their medical devices to the MDCO for listing under the MDACS by a date not later than six (6) months after commencement of the Validity Period. The Seller must provide relevant details on the listing in the relevant section under Schedule B. 7.4 Successful Sellers must update the Authority the listing record of their medical devices and/or status of their submissions to DH on a quarterly basis until all devices supplied under their Standing Quotations are listed. If, in the sole opinion of the Authority, any Seller fails to submit its application(s) to DH before the committed date provided in accordance with Clause 7.3 of this Part or fails in the listing of its medical device(s) under the MDACS before expiry of the Validity Period, the Authority may in its absolute discretion disqualify that Seller from participation in any future tenders and quotations issued by the Authority, for such period as the Authority may in its entire discretion consider appropriate. 7.5 The requirements in relation to the MDACS in this Clause 7 shall be referred to as the

Listing under the Medical Device Administrative Control System. 7.1 Currently, there is no specific legislative control over legislation that regulates the importation manufacture, import, distribution and sale of MDs (which may include medical devices equipment and consumables) in Hong Kong. Pending In order to pave the enactment way for implementing the long-term statutory control of legislationmedical devices, the Department of Health of the Government of Hong Kong SAR (“DH”) of the HKSAR Government has set up the “Medical Device Administrative Control System” (“MDACS”) MDACS with the following features: (a) a listing system for medical devicesapplicable MDs*, under which manufacturers and importers of medical devices the applicable MDs or their respective local representative could voluntarily list their applicable MDs with DH; and (* “Applicable MDs” are the Class II/III/IV general medical devices with and Class B/C/D in-vitro diagnostic MDs according to the DH; andclassification rules of MDs under MDACS.) (b) an adverse incident event reporting system, through which the manufacturers, importersmanufacturers (or their respective local representative), users, and the general public could report adverse incidents events associated with medical devices to the DH for evaluation to reduce the likelihood of, or to prevent repetition of adverse incidents, or alleviate consequences of such repetitionDH. 7.2 The MDACS is run by the Medical Device Control Office under DH Division (“MDCOMDD”)) under DH. Sellers may visit MDD’s website: or contact MDD at telephone number 0000 0000 or facsimile number 3157 1286 or via e- mail: xxx@xx.xxx.xx for further information on the MDACS. 7.3 The Hospital Authority supports the MDACS’s objective to safeguard patient safety, and has included in this Invitation to Quote the requirement for the Seller Sellers to commit to the submission of their medical devices offered products which are applicable MDs to the MDCO MDD for listing under the MDACS by a date not later than six (6) months after commencement of the Validity Periodcontract commencement. The Seller must Please provide relevant details on the listing in the Schedule B with supporting documents for all offered products which are applicable MDs. If Sellers’ offered products (or any of them) are not applicable MDs according to the classification rules of MDs under MDACS or are otherwise not subject to listing under the MDACS, please declare the same and provide the relevant section under details in Schedule B.B with supporting documents. 7.4 Successful The successful Sellers must shall, upon request by the Authority, update the Authority the listing record of their medical devices offered products which are applicable MDs under MDACS and/or status of their its submissions to DH on a quarterly basis until all devices supplied for listing of such products under their Standing Quotations are listedMDACS. If, in the sole opinion of the Authority, any the successful Seller fails to submit its application(s) to DH before the committed date provided in accordance with Clause 7.3 of this Part above or fails the MDACS listing cannot be completed within twelve (12) months after contract commencement or the successful Seller’s declaration under Clause 3 in Schedule B are found to be invalid, incorrect or unsubstantiated, the listing Authority may, without prejudice to the Authority’s other rights and remedies under the contract or by law, exercise all or any of its medical device(srights under Clause 27.1 of Part III (Terms and Conditions) under [and/or disqualify that Seller, its holding company and subsidiaries from participation in any future tenders issued by the MDACS before expiry of the Validity PeriodAuthority], as the Authority may in its absolute discretion disqualify that Seller from participation in any future tenders and quotations issued by the Authority, for such period as the Authority may in its entire discretion consider appropriate. 7.5 The Sellers shall confirm their agreement to comply with all statutory requirements within the prescribed period under the legislation should the statutory control of medical devices takes effect in relation to the MDACS in this Clause 7 shall be referred to as theSchedule B.

Listing under the Medical Device Administrative Control System. 7.1 13.1 Currently, there is no specific legislative control over legislation that regulates the importation manufacture, import, distribution and sale of MDs (which may include medical devices equipment and consumables) in Hong Kong. Pending In order to pave the enactment way for implementing the long-term statutory control of legislationmedical devices, the Department of Health of the Government of Hong Kong SAR (“DH”) of the HKSAR Government has set up the “Medical Device Administrative Control System” (“MDACS”) MDACS with the following features: (a) a listing system for medical devicesapplicable MDs*, under which manufacturers and importers of medical devices the applicable MDs or their respective local representative could voluntarily list their applicable MDs with DH; and (* “Applicable MDs” are the Class II/III/IV general medical devices with and Class B/C/D in-vitro diagnostic MDs according to the DH; andclassification rules of MDs under MDACS.) (b) an adverse incident event reporting system, through which the manufacturers, importersmanufacturers (or their respective local representative), users, and the general public could report adverse incidents events associated with medical devices to the DH for evaluation to reduce the likelihood of, or to prevent repetition of adverse incidents, or alleviate consequences of such repetitionDH. 7.2 13.2 The MDACS is run by the Medical Device Control Office under DH Division (“MDCOMDD”)) under DH. Sellers may visit MDD’s website: or contact MDCO at telephone number 0000 0000 for further information on the MDACS. 7.3 13.3 The Hospital Authority supports the MDACS’s objective to safeguard patient safety, and has included in this Invitation to Quote Agreement the requirement for the Seller Sellers to commit to the submission of their medical devices offered products which are applicable MDs to the MDCO MDD for listing under the MDACS by a date not later than six (6) months after commencement of the Validity Periodcontract commencement. The Seller must Please provide relevant details on the listing in the Schedule B with supporting documents for all offered products which are applicable MDs. If Sellers’ offered products (or any of them) are not applicable MDs according to the classification rules of MDs under MDACS or are otherwise not subject to listing under the MDACS, please declare the same and provide the relevant section under details in Schedule B.B with supporting documents. 7.4 Successful 13.4 The successful Sellers must shall, upon request by the Authority, update the Authority the listing record of their medical devices offered products which are applicable MDs under MDACS and/or status of their its submissions to DH on a quarterly basis until all devices supplied for listing of such products under their Standing Quotations are listedMDACS. If, in the sole opinion of the Authority, any the successful Seller fails to submit its application(s) to DH before the committed date provided in accordance with Clause 7.3 of this Part 13.3 above or fails the MDACS listing cannot be completed within twelve (12) months after contract commencement or the successful Seller’s declaration under Clause 4 in Schedule B are found to be invalid, incorrect or unsubstantiated, the listing Authority may, without prejudice to the Authority’s other rights and remedies under the contract or by law, exercise all or any of its medical device(s) rights under Clause 41 of Part II [and/or disqualify that Seller, its holding company and subsidiaries from participation in any future tenders issued by the MDACS before expiry of the Validity PeriodAuthority], as the Authority may in its absolute discretion disqualify that Seller from participation in any future tenders and quotations issued by the Authority, for such period as the Authority may in its entire discretion consider appropriate. 7.5 The 13.5 Sellers shall confirm their agreement to comply with all statutory requirements within the prescribed period under the legislation should the statutory control of medical devices takes effect in relation to the MDACS in this Clause 7 shall be referred to as theSchedule B.

Listing under the Medical Device Administrative Control System. 7.1 8.1 Currently, there is no specific legislative control over legislation that regulates the importation manufacture, import, distribution and sale of medical devices in Hong Kong. Pending In order to pave the enactment way for implementing the long-term statutory control of legislationmedical devices, the Department of Health of the Government of Hong Kong SAR (“DH”) of the Government of the HKSAR has set up the “Medical Device Administrative Control System” (“MDACS”) with the following features: (a) a listing system for medical devices, under which manufacturers and importers of medical devices or their respective local representative could voluntarily list their medical devices with the DH; and (b) an adverse incident event reporting system, through which the manufacturers, importersmanufacturers (or their respective local representative), users, and the general public could report adverse incidents events associated with medical devices to the DH for evaluation to reduce the likelihood of, or to prevent repetition of adverse incidents, or alleviate consequences of such repetitionDH. 7.2 8.2 The MDACS is run by the Medical Device Control Office under DH Division (“MDCOMDD”)) under DH. Bidders may visit MDD’s website. The MDACS is run by the Medical Device Division (“MDD”) under DH. Bidders may visit MDD’s website: or contact MDD at telephone number 0000 0000 or via e-mail: xxx@xx.xxx.xx for further information on the MDACS. 7.3 8.3 The Hospital Authority supports the MDACS’s objective to safeguard patient safety, and has included in this Invitation to Quote quote the requirement for the Seller Bidders to commit to the submission of their medical devices to the MDCO MDD for listing under the MDACS by a date not later than six (6) months after commencement of the Validity Periodcontract commencement. The Seller must Please provide relevant details on the listing in the relevant section under Schedule B. 7.4 Successful Sellers must 8.4 The successful Bidders shall update the Hospital Authority the listing record of their medical devices and/or status of their submissions to DH on a quarterly basis until all devices supplied under their Standing Quotations this Quotation are listed. If, in the sole opinion of the Authority, any Seller fails Bidder failed to submit its application(s) to DH before the committed date provided in accordance with Clause 7.3 8.3 of this Part or fails failed in the listing of its medical device(s) under the MDACS before expiry of the Validity PeriodContract, the Authority may in its absolute discretion disqualify that Seller Bidder, its holding company and subsidiaries from participation in any future tenders and quotations issued by the Authority, for such period as the Authority may in its entire discretion consider appropriate. 7.5 The requirements in relation to the MDACS in this Clause 7 shall be referred to as the

Listing under the Medical Device Administrative Control System. 7.1 14.1 Currently, there is no specific legislative control over the importation and sale of medical devices in Hong Kong. Pending the enactment of legislation, the Department of Health of the Government of Hong Kong SAR (“DH”) has set up the “Medical Device Administrative Control System” (“MDACS”) with the following features: (a) a listing system for medical devices, under which manufacturers and importers of medical devices could voluntarily list their medical devices with the DHDepartment of Health; and (b) an adverse incident reporting system, through which the manufacturers, importers, users, and the general public could report adverse incidents to the DH Department of Health for evaluation to reduce the likelihood of, or to prevent repetition of adverse incidents, or alleviate consequences of such repetition. 7.2 14.2 The MDACS is run by the Medical Device Control Office under DH (“MDCO”). Sellers may visit MDCO’s website: or contact MDCO at telephone number 0000 0000 for further information on the MDACS. 7.3 14.3 The Hospital Authority supports the MDACS’s objective to safeguard patient safety, and has included in this Invitation to Quote Agreement the requirement for the Seller Sellers to commit to the submission of their medical devices to the MDCO for listing under the MDACS by a date not later than six (6) months after commencement of the Validity PeriodAgreement commencement. The Seller must Please provide relevant details on the listing in the relevant section under Schedule B.B (Schedule of Compliance). 7.4 Successful 14.4 The successful Sellers must shall update the Hospital Authority the listing record of their medical devices and/or status of their submissions to DH on a quarterly basis until all devices supplied under their this Standing Quotations Quotation are listed. If, in the sole opinion of the AuthorityHA, any Seller fails failed to submit its application(s) to DH before the committed date provided in accordance with Clause 7.3 14.3 of this Part or fails failed in the listing of its medical device(s) under the MDACS before expiry of the Validity PeriodAgreement, the Authority HA may in its absolute discretion disqualify that Seller Seller, its holding company and subsidiaries from participation in any future tenders and quotations issued by the AuthorityHA, for such period as the Authority HA may in its entire discretion consider appropriate. 7.5 The requirements in relation to the MDACS in this Clause 7 shall be referred to as the