Another Special Region for Unapproved Device Usage in China—”Big Bay Area”

Unapproved medical devices can be clinically used in “Big Bay Area”, constituting Guangdong, Hong Kong and Macao with over 70 million people, as long as they are used in Hong Kong and Macao’s public hospitals and are granted importation certificate by Guangdong provincial government, according to joint announcement by eight central government agencies on November 25, 2020.

Key Takeaways for Overseas Manufacturers

The policy specifies the following aspects that overseas manufacturers need to pay attention:

1. Suspension of legal provisions: “For any Class II and Class III imported medical device in China, the foreign manufactures shall submit the application and home country approval to NMPA for registration approval”, published by Medical Device Supervision and Management in March 2014. However, devices used in nine cities in Guangdong are exempted now,
2. Scope of institutions: Health providers from Hong Kong and Macao that have medical services in nine cities in Guangdong are applicable. They can be sole proprietorship, joint venture, or cooperation, and are approved by the Guangdong Provincial Health Commission.
3. Step-by-step implementation: The Shenzhen Hospital of the University of Hong Kong will be used as a pilot in the first stage, and it will be gradually expanded to other designated medical institutions.
4. Medical device catalog: Guangdong government determines the imported medical device catalogue based on clinical needs.
5. Importation certificate: the designated medical institutions submit the application for the use of equipment, and the Guangdong Provincial Health Commission will evaluate the clinical needs and issue an audit opinion. For the content of evaluation request please email info@inspirativemed.com.
6. Customs clearance: the designated medical institutions shall apply for the medical device import declaration according to the approval opinions of the Guangdong Provincial Food and Drug Administration, and the Guangdong Customs shall verify and release based on regulations. Designated medical institutions commission medical device companies to purchase, import and distribute medical devices.

Difference between Guangdong and Hainan

At present, both Hainan and Big Bay Area have successively obtained the authorization to use urgently needed medical devices. The differences of the new policies between  Hainan Boao and Big Bay Area are shown as follows:

1. Products in Big Bay area contingent on approval by HK and Macao where Hainan more on overseas major countries regulatory approval.
2. Big Bay Area’s policy is brand new without any specific directions. Only one hospital designated to be able to apply to set up process for other hospitals. They still need to apply for urgent use, similar process as Hainan.
3. No mention about RWD and how much Hainan details can be used in the Big Bay area.