Listing under the Medical Device Administrative Control System. I/We confirm that:
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:
Listing under the Medical Device Administrative Control System. 7.1 Currently, there is no specific legislation that regulates the manufacture, import, distribution and sale of MDs (which may include medical equipment and consumables) in Hong Kong. In order to pave the way for implementing the long-term statutory control of medical devices, the Department of Health (“DH”) of the HKSAR Government has set up the MDACS with the following features:
Listing under the Medical Device Administrative Control System. 27.1 The Seller shall, upon request from the Authority, update the Authority the listing record of the Goods which are applicable MDs under MDACS and/or status of its submissions to DH for listing of such Goods under MDACS. If, in the sole opinion of the Authority, the Seller fails to submit its application(s) to DH before the committed date provided in accordance with Clause 7.3
Listing under the Medical Device Administrative Control System. The Seller agrees to comply with all statutory requirements within the prescribed period under the legislation should the statutory control of medical devices takes effect. The Seller shall demonstrate to the Authority its compliance with the statutory requirements upon request by the Authority. If the Seller fails to comply with any statutory requirement or demonstrate compliance of the same, the Authority may, without prejudice to its other rights and remedies provided under this Agreement or otherwise according to law:
