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. I/ We confirm that:
(a) The following medical device(s) under offer is/are already listed under the MDACS with the following details:- Medical device under offer (Manufacturer (Make), Brand and Model) Listing number issued by the DH Validity of the MDACS certificate (From) (To) Device Description under MDACS
(b) The following medical device(s) under offer has/have been submitted to the Medical Device Control Office (MDCO) under DH for listing under the MDACS by the following date(s):- Medical device under offer (Manufacturer (Make), Brand and Model) Actual date of submission to DH Application reference number provided by DH
(c) The following medical device(s) under offer will be submitted to the Medical Device Control Office (MDCO) under DH for listing under the MDACS by the following date(s):- Medical device under offer (Manufacturer (Make), Brand and Model) Planned date of submission to DH (a date not later than 6 months after commencement of the Validity Period) Name of Seller : Seller’s Chop : Name : Position Held : Signature : E-mail Address : Date : Tel. No: Fax No.:
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. I/ We confirm that:
(a) The following medical device(s) under offer is/are already listed under the MDACS with the following details:- Medical device under offer (Manufacturer, Brand and Model) Listing number issued by the DH Validity of the MDACS certificate Device Description under MDACS (From) (To) (b) The following medical device(s) under offer has/have been submitted to the Medical Device Division (MDD) under DH for listing under the MDACS on the following date(s):- Medical device under offer (Manufacturer, Brand and Model) Actual date of submission to DH Application reference number provided by DH I / We also confirm that the information and supporting documents provided under the “Checklist for Medical Devices to be Listed under MDACS” in the Appendix I to this Schedule B are accurate and not misleading. Name of Seller : Name : Authorized Signature : Seller’s Chop : Position Held : E-mail Address : Date : Tel. No: Fax No.:
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:
(i) reject all or part of the Goods which fail to meet any statutory requirement (or those which the Seller fails to demonstrate compliance with the statutory requirements) (“Relevant Goods”) delivered hereunder (notwithstanding any acceptance or deemed acceptance of the Relevant Goods by the Authority or the making of payment by the Authority);
(ii) cancel, or suspend the performance of, any order placed by the Authority for the Relevant Goods which is not yet delivered;
(iii) delete the Relevant Goods from the Agreement (if the Agreement is awarded with more than one item) such that the Authority shall not be obliged to order a minimum quantity of the Relevant Goods with the Seller during the term of the Agreement notwithstanding any provision contained in the Agreement; and/or
(iv) terminate the Agreement forthwith. Any monies paid by the Authority to the Seller in respect of the Relevant Goods which have been rejected shall be refunded to the Authority and the Authority may purchase from other sources alternate supplies to substitute for the Relevant Goods rejected and those which, but for the deletion of the Relevant Goods from the Agreement or the termination of the Agreement, would be supplied by the Seller to the Authority under the Agreement, and the Seller must, on demand by the Authority, pay to the Authority the additional costs and expenses in obtaining such alternate supplies, including but not limited to price difference and related freight and delivery charges. IN WITNESS this Agreement has been duly executed by or on behalf of the parties the day and year first above written. SIGNED by ) for and on behalf of the HA ) SIGNED by ) for and on behalf of the Seller ) in the presence of: ) SIGNED by ) for and on behalf of the HA ) SIGNED by for and on behalf of the Seller in the presence of: Signature of representative 1: Full Name of representative 1: Title: ) ) ) Signature of representative 2: Full Name of representative 2: T...
