The China (Jiangsu) Pilot Free Trade Zone Suzhou Area (Suzhou FTZ) in SIP recently announced the Measures for Medical Device Manufacturers in Suzhou Industrial Park to Report on Purchase of Drugs for Production Purpose (Trial), which is also known as “Yanyigou”. The aim is to help medical devices companies prove the legal compliance of their purchase of drugs used in production process and therefore accelerate the manufacturing and registration of their products.
Related authorities of the FTZ had conducted a wide-range survey to learn about medical devices companies’ needs before the adoption of the new policy.
Under the policy, medical device manufacturers can report on their purchase of drugs from the domestic market on a voluntary basis and get the proof for legal compliance, and the local market regulator will conduct routine inspections and authorize a third party to carry out random inspections over the use of the drugs.
“The policy can provide strong support for our project,” said Suzhou Rainmed Medical Technology Co Ltd, an SIP-based, HKEX-listed company engaged in vascular interventional surgery robotics. The company recently submitted the report on its purchase of water for injection, becoming the first beneficiary of the policy.
December 27, 2024
