NMPA to Pilot Program Allowing Hong Kong Approved Products to Be Sold in Mainland China

Program Will Expand to 8 Major Guangdong Cities

Per article 11, item 2 in Decree 680, the National Medical Products Administration (NMPA) has announced that they will begin piloting a new program that, when fully implemented, would allow public hospitals in the major Guangdong cities to import Hong Kong and Macao approved products. The initiative titled, Work Plan for Supervision, Innovation and Development of Drugs and Medical Devices in Guangdong-Hong Kong- Macau Greater Bay Area, will continue the expansion of the Chinese Pearl River Delta economic region to include Hong Kong and Macao by allowing designated hospitals in mainland China expedited access to Hong Kong approved products.

The program will begin with the University of Hong Kong-Shenzhen Hospital and will expand to other hospitals as permitted by the Guangdong Health Commission. With a population of 70-75 million, Guangdong’s 9 major cities (not including Hong Kong and Macao) provide manufacturers already selling in Hong Kong with a steppingstone into the bigger market without any additional major regulatory hurdles. For manufacturers contemplating their entrance into the China’s mainland market, this is another incentive as Hong Kong’s regulatory requirements are much more straight forward and do not incur government review fees.

Initial Steps of the Pilot Program

The pilot program will begin with a few hospitals in the province and expand as long as there are no issues with the implementation. As the program expands, manufacturers with medical devices that meet the following criteria could gain expedited access to an increasing number of designated public hospitals in the Greater Bay area.

Products meeting the following:

• Purchased and used by public hospitals in Hong Kong or Macau
• Urgent clinical needs
• Clinical advancement

Since the program will likely require manufacturers acquire sponsorship from one of the designated Guangdong hospitals as part of the expedited application process, innovations and products not readily available through Chinese channels will likely have an easier time utilizing this new pathway, especially at the beginning.

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