China OEM production of high-risk implants will soon not be able to be entrusted to other parties as specified in the Order 739.
On November 19, 2021, the NMPA (National Medical Products Administration) issued the draft catalogue of medical device products to be prohibited from OEM (Original Entrusted Manufacture) production in China. The catalogue was first issued in April 2005, and the revised version was later issued (No.18 – 2014) on September 26, 2014. According to the Order 739 implemented in June 1, 2021, the registrants and filers will only be able to self-manufacture medical devices or entrust a qualified manufacturer for production in general.
22 high-risk medical implants have been added in the draft catalogue as below:
Active implantable medical device
1. Implantable Cardiac Pacemaker
2. Implantable cardioverter defibrillator
3. Implantable cardiac contractile force regulator
4. Implantable circulatory support devices
Non-active implantable medical device
1. Sports injury soft tissue replacement implant (Allograft)
2. Acrylic bone cement
3. Allogeneic bone repair materials
4. Dural membrane patch
5. Aneurysm clip
6. Intracranial stent system
7. Intracranial embolization equipment
8. Intracranial coil system
9. Intracranial aneurysm blood flow guide device
10. Cardiovascular implants (except peripheral vascular stents)
11. Plastic filling materials
12. Plastic injection fillers
13. Breast implants
14. Tissue engineering scaffold materials
Other medical devices not allowed for sub-contract production
1. Absorbable surgical anti-adhesion dressing
2. Tissue engineered biological amniotic membrane
3. Tissue engineering cornea stroma
4. Vaginal mesh and pelvic floor mesh
Because the manufacturing of medical devices in China are much more mature than before, the NMPA has removed some products from the previous catalogue in this draft that would allow the OEM production in future.
On November 15, 2021, the NMPA issued a draft guideline for writing OEM quality agreements in China. According to the draft guideline, registrants or filers shall sign this agreement with OEM manufacturers to specify the rights, obligations and responsibilities of both sides in the entire process of achieving product quality. Read our separate blog post for more detailed information.
By Alice Liu and Jacky Li. Contact Cisema if you would like to learn more.