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Which 22 Devices Not Allowed for Contract Manufacturing?

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The NMPA published the “Catalog of Medical Devices Prohibiting of Entrusted Production” on November 17, 2021, providing the scope of 22 devices which are not allowed for contract manufacturing.

NMPA has introduced the MAH system for 18 provinces including the booming med-tech markets of Beijing, Zhejiang, Jiangsu and Shandong in August 2019. The MAH system has major implications for the developers who have limited manufacturing capabilities. Companies that register devices do not have to be the manufacturers. They may commission one or multiple qualified contract manufacturing organization(s) to manufacture the approved medical devices.

The MAH system helps incentivize the medical device developers to focus on research and development, and it accelerates the marketing process of the device. The first device approved though the system was the portable ECG recorder. It only took 26 working days from filing acceptance to final approval.

The Medical Devices Contract Manufacturing List

The Prohibition Catalog includes but not not limited to the following devices:

Active Implantable Devices

  • Implantable cardiac pacemaker
  • Implantable cardioverter defibrillator
  • Implantable cardiac contractility regulator
  • Implantable circulatory auxiliary equipment

Non-Active implantable Devices

  • Sports injury soft tissue replacement implant
  • Acrylic resin bone cement
  • Allogeneic bone repair materials
  • Dural membrane patch
  • Aneurysm clip
  • Intracranial stent system
  • Intracranial embolization equipment
  • Intracranial coil system
  • Intracranial aneurysm blood flow guide device
  • Cardiovascular implants (except peripheral vascular stents)

For an English copy of the Prohibition Catalog please email info@ChinaMedDevice.com.