Hong Kong drafts new rules for medical products liaisons

Local representatives of foreign medical products firms in Hong Kong will be required to strengthen their procedures for handling, storing and delivering medical devices under new guidelines being proposed by the government.

The draft rules on local responsible persons (LRPs), who serve as liaisons between manufacturers, distributors, the public and the government, would come on top of a series of requirements on LRPs already in place. Under those current requirements, LRPs must maintain distribution records, handle complaints, track specific medical devices, share records with medical inspectors, submit post-market surveillance records if asked and meet Hong Kong advertising requirements.

The new guidance from Hong Kong’s Medical Device Control Office (MDCO) is designed to ensure that medical devices are not adversely impacted by poor storage conditions.

Other elements of the draft revised guidance from MDCO tighten restrictions on transferring devices from one LRP to another and mandate LRPs institute a process to receive emergency complaints 24 hours a day. If an LRP is permanently removed for non-compliance, MDCO would automatically de-list all the devices covered by the LRP but continue to enforce post-market safety requirements on those devices.