HONG KONG EXTENDS PILOT PROGRAM TO RECOGNIZE CHINA AND KOREA AS REFERENCE COUNTRIES

Accelerating regulatory timeline

The Medical Device Division, or MDD (formerly the MDCO), has extended reference country status to China and Korea through the end of 2020. Under the program, medical devices that are approved for sale in these countries can forgo local conformity assessment review in Hong Kong, greatly accelerating their regulatory timeline.   

“Reference Countries” is used to identify which country’s approvals are eligible for expedited registration routes in different countries, whether it’s shorter review times and costs, to skipping in-country clinical trials.” 

Competitive market access

Manufacturers in Korea and China are eager to see this program turn out successful as it will allow them to gain access to the Hong Kong market just as quickly as manufacturers with products approved in Canada, Australia, the European Union, Japan and the USA; the 5 current Reference Countries. While the medical device registration system is technically voluntary, it’s important for serious manufacturers to participate as the vast majority of hospital purchases are of registered products. Currently, manufacturers without Reference Country approval need to undergo a conformity assessment by one of the three approved Conformity Assessment Bodies (CAB), BSI, SGS, or TUV SUD.

By allowing manufacturers to show conformity to the MDD’s assessment requirements by using NMPA or MFDS approvals, Chinese and Korean manufacturers would save 6-9 months during the application process.