China – Hong Kong Proposes Overhaul of Guidance on Medical Device Responsible Persons

The Hong Kong Medical Device Control Office (MDCO) is preparing to overhaul its guidance on the listing of local responsible persons (LRPs) for new medical devices. MDCO is holding a series of events next month to brief the industry on the changes to the 2005 guidance.

LRPs are entities that place medical devices on the Hong Kong market and serve as a link between manufacturers, distributors, the public and the government. Under the current guidance, LRPs are also expected to maintain distribution records, handle complaints, share records with inspectors and perform a range of other tasks involved in the listing and oversight of medical devices.

The revised guidance maintains most of the tasks listed in the current text but also features some new additions. MDCO is proposing to require LRPs to implement and maintain documented procedures in the handling, storage and delivery of medical devices. That requirement, which is absent from the current guidance, is intended to ensure devices are protected from environmental factors that could affect their performance and stop nonconforming and recalled products from being sold…