OEM prohibited medical devices means original equipment manufacturers (OEM) are banned from production in China for certain medical devices. On March 24, 2022, the NMPA announced (No.17-2022) the the latest finalized version of the product catalogue prohibiting certain products sold in China from being manufactured by an OEM.
According to the Order 739 implemented in June 1, 2021, in general the registrants and filers at NMPA can self-manufacture medical devices or entrust a qualified manufacturer or OEM for production. However, the Order 739 specified that the manufacturing of high-risk medical implants cannot be entrusted to other parties. Read our separate blog post for more information about the Order 739.
OEM Prohibited Medical Devices – Catalogue Highlights
Key highlights of the catalogue update prohibiting certain high-risk products from OEM production are summarised by our regulatory experts below.
- As compared to the 2017 edition of the catalogue, implantable insulin pumps, surgical hemostatic materials, etc. will no longer be prohibited due to a more developed production process now in China and relatively low risk in the market.
- The new catalogue covers 3 types of active implantable devices (e.g. implantable cardiac pacemakers) and 9 types of passive implantable devices (e.g. intracranial stent systems), as well as allogeneic implantable medical device and implantable medical devices with animal tissue origin.
- For comparison between the 2014 version and 2022 version, please refer to the following catalogues:
- According to the guideline for writing OEM quality agreements in China (No.20-2022), OEM manufacturers and the registrants will be required to sign the OEM quality agreement specifying the obligations and responsibilities of both sides.
- Read our separate blog post about the draft catalogue issued on November 19, 2021. The finalized catalogue had some products removed from the draft catalogue including, but not limited to the following:
- Implantable cardioverter defibrillator
- Intracranial embolization equipment
- Intracranial coil system
- Tissue engineered biological amniotic membrane
By Jacky Li. If you would like to learn more about our localization services in China for original equipment manufacturer (OEM) or market holder authorization (MAH) or our registration and CRO services for medical devices, IVDs, pharmaceuticals, cosmetics or other products, please contact Cisema.