The NMPA published the “Catalog of Medical Devices Prohibited from Contract Manufacturing” on March 24, 2022. Compared with the draft version, issued in November 2021, with 22 devices on the list, the final document permits nine devices for contract manufacturing:
- Implantable cardioverter defibrillator
- intracranial embolization device
- intracranial coil system
- Tissue engineered biological amniotic membrane
- Corneal stromal sheet
- Vaginal patch, pelvic floor patch
- … …
MAH System
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 start-up companies with no or limited manufacturing capabilities.
Companies that register devices do not have to be the manufacturers at the same time anymore. They can design and develop the products and then commission one or multiple qualified contract manufacturing organization(s) to make their products for NMPA registration approval.
The MAH system helps incentivize the medical device companies to focus on research and development and consolidate the manufacturing to larger companies. It accelerates the innovation and marketing process of the devices. The first device approved though the system was the portable ECG recorder. It only took 26 working days from filing acceptance to final approval.
To consult on the MAH pathway, please email info@ChinaMedDevice.com.
Prohibition List
The contract manufacturing restriction catalog includes but not limited to the following class III high-risk devices:
Active Implantable Devices
- Implantable cardiac pacemaker
- Implantable cardiac contractility regulator
- Implantable circulatory auxiliary equipment
Non-Active implantable Devices
- Dura (spinal) patch (except products that do not contain materials of animal origin)
- Intracranial stent system
- Intracranial aneurysm blood flow diverter
- Cardiovascular implants (except peripheral stents, vena cava filters, and cardiovascular embolization devices)
- Filler material for aesthetic use
- Injectable fillers for aesthetic use
- breast implants
- Tissue engineering scaffold materials (except products that do not contain allogeneic or animal-derived materials)