Hong Kong Hones Voluntary Medical Device Registration System

Continuing to refine its system for registering medical devices, Hong Kong’s Medical Device Control Office is encouraging importers to adhere to new rules designed to improve quality control for consumers and decrease uncertainty for manufacturers.

In accordance with the new procedures, which went into effect June 1, 2018, Hong Kong importers are asked to maintain a staffed office in Hong Kong to carry out business operations. Importers are also asked to maintain quality management systems for the devices they import, including establishing testing and storage procedures. In addition, importers are asked to maintain clear records of the disposition of their products for at least seven years after the projected service life of any medical device.

Unlike in China, the listing system in Hong Kong, a special administrative region of China, is voluntary. But Hong Kong is increasingly seeking to follow established international precedents and create a risk-based regulatory framework for medical devices. Device makers will find it increasingly difficult to do business in Hong Kong if they choose not to take part in the new regime. Hong Kong hospitals and healthcare professionals are more likely to use voluntarily listed devices, and the government has signaled that it is moving towards a mandatory system soon.