On March 1, 2024, the Medical Device Division (MDD) released the code of practice (CP-05) specifically for the listed medical device distributors in Hong Kong, aiming to stipulate the requirements that have to be complied with by the distributors.
The requirements listed by MDD include the scope of:
Premises and Equipment
Implementation and Maintenance of Procedures
Inspections
Advertisement and Promotional Materials
Notification of Changes
Notification of Renewal of Inclusion on the Listed Distributor
The Listed Distributor is required to establish a properly manned premise in Hong Kong, including but not limited to, an office, receiving/delivering area, and maintenance area, in which the distributions will take place. It is important to ensure the condition is clean and complies with the instructions stated on the label. The premise should keep a record of the temperature data and ensure all measuring equipment is inspected from time to time.
All distribution and post-market activities must be documented as conformity evidence to establish the necessary controls for identification, storage, security, retention time, and disposition. The Listed Distributor should retain the records for seven (7) years or the projected service life of the medical devices, whichever is longer.
All the supply records and updated lists of medical devices distributed should be documented with the make, model, batch number, serial number, quantity of the medical device, and other sufficient information needed for tracking or withdrawal. An action under CAPA would be taken if the Listed Distributor fails to ensure all the documented procedures are reviewed regularly.
Supply records and documented procedures should be ready to be inspected by the MDD and Listed Distributors must be able to submit other requested documents within the specific timeline given, including the premise inspection.
Submission of Renewal and Change Application Form for Listed Importers/Distributors (MD 203) should be submitted not later than four (4) weeks after the changes made to the submitted distributors particulars and MDD may request evidence documentary of the change within two (2) weeks.
While, renewal of current inclusion on the List of Distributors must be submitted under Renewal and Change Application Form for Listed Importers/Distributors (MD 203) not less than three (3) months and not more than six (6) months prior the expiry. If the renewal submitted after the expiry of the current listing, the listing will be invalid and shall not be purported as a Listed Distributor until approved by the MDD. Distributor may apply for inclusion on the List of Distributors if the current listing expired.
Delisting
MDD has the authority to cease the Listed Distributor from the current listing if the party fails to comply with the MDACS requirements, fails to address any situation that rise the public safety concern or medical device hazards, or, requested by the Listed Distributor.
Appeal
Distributor may appeal the decision from the Distributor Listing Approval Board on application rejection or Listed Distributor removal within fourteen (14) working days of being notified, but that does not suspend the delist decision from MDD. The appeal outcome will be notified to the distributor within four (4) weeks upon the appeal application submission (including the supporting documents, if requested).
Source: Medical Device Decision (MDD)
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