New Regulation for Overseas Medical Devices in Hainan

On June 2, the Hainan MPA announced (No.28 – 2020) the implementation of the new regulation to support the urgent clinical needs of medical device imports in Hainan’s Boao Lecheng International Medical Tourism Pilot Zone, also known as the Boao Hope City, replacing the temporary regulation (No.30 – 2019) announced in April 4, 2018.

What’s New?

• Medical institutions, importers and warehouses must keep a record of incoming and outgoing goods (with receipts as proof):
  • The records must be kept as long as 3 years (after expired) for medical device products with an expiry date
  • The records must be kept as long as 5 years for medical device products without an expiry date
  • The records must be kept forever for implantable medical device products
• Medical institutions are required to monitor the status of imported medical devices with clinical needs, establish a management system for adverse events reporting and address the responsible person to follow up

Prerequisites for importing medical devices urgently needed for clinical treatment

• There are no medical devices of the same type existing in the market yet
• The medical device can effectively provide clinical treatment or prevention to the subject (patient) with a life-threatening disease
• The medical device demonstrates significant clinical advantages

By Jacky Li. Contact Cisema if you would like to learn more.