Hainan MPA Accelerates Registration Approval for Overseas Medical Devices

On 31.03.2020, the Hainan MPA (Medical Products Administration) announced plans to boost the development of the medical and pharmaceutical industry in the Hainan free trade zone, utilizing digitalization, fast-track processing procedures and real-world data application.

This followed a press conference held by the Hainan MPA on 28^th March in which the Hainan MPA discussed in detail the NMPA’s approval of Allergan’s glaucoma drainage tube product using real-world data obtained from Hainan’s Pilot Zone (as reported in our previous newsletter).

Goals to facilitate administrative approvals

– Digitalize the medical device registration procedure in 2 years

– Speed up the approval process for unregistered importing medical devices and pharmaceutical products to:

• complete within 7 working days if certain conditions are met
• complete within 48 hours for special emergency situations

– Combining QMS inspections and production license check to shorten the application time

– Reduce the time needed for the technical review of medical devices by 10%

– Actively promote the pilot application of clinical real-world data

With upcoming plans to optimize the Hainan free trade zone, it will attract many overseas enterprises to utilize these business opportunities to enter China’s medical and pharmaceutical industry.

By Jacky Li. Contact Cisema to learn more.