On April 30, 2015, Hong Kong announced a new voluntary registration system for medical device distributors. Distributors who apply for registration will be listed on a searchable online portal of device manufacturers and distributors, hosted by Hong Kong’s Medical Device Control Office. The inclusion of medical device distributors on this site should allow foreign device companies to more easily search for reputable distributors in Hong Kong.
To qualify, device distributors must have a local office in Hong Kong. Also, the distributors must have procedures in place to appropriately maintain records, store and deliver devices, manage product alerts and recalls, manage reportable adverse events and complaints, track high-risk devices, and provide maintenance and services for distributed devices. Class I device distributors will not be included in the new system.