The Medical Device Control Office (MDCO) under the Department of Health has proposed guidelines on medical device importer listings March 30, 2007. Currently, this listing of importers would be voluntary.
Importers can apply for official listing, whether or not they import medical devices specified in the Medical Device Administrative Control System. The MDCO hopes that this listing will help increase medical device vigilance.
Applicants would need to submit a general form, distribution records for the imported products, procedures for the management of these distribution records, and other documents. The general form mainly consists of contact information and the role of the importer (as a distributor for another company, for their own product, etc). The management procedures would describe the identification, storage, protection, retrieval, retention time and disposal of the distribution records.
During the application process and after approval, importers must notify the MDCO of any changes to the information submitted. The MDCO may also ask importers to confirm reported changes with additional document submissions. In these cases, the importer would have three days to submit such documents.
The MDCO estimates that application review and approval will take eight weeks to complete. Approved applicants will be on the list for two years. Listed importers must re-apply three months before this two year expiration date. Application for inclusion in the List of Importers will be free of charge. Rejections may be appealed within four weeks of receiving notice of rejection.
Importers would also be responsible for deciding how to deal with complaints, recall notices, hazard alerts, and adverse events with their appropriate Local Responsible Persons (LRPs). An LRP must be either a legal person incorporated in Hong Kong, or a natural or legal person with a business registration in Hong Kong. It can also be the manufacturer if an LRP does not exist and the manufacturer has a place of business in Hong Kong.
The MDCO has stated that inclusion on this list does not imply that the importer has the required regulatory approvals or is in compliance with the applicable laws.
This draft document is currently open for comments until the end of April 2007.