OEM Quality Agreement for Medical Devices – Draft guidelines issued

OEM quality agreement for medical devices helps to set out the the rights, obligations and responsibilities of registrants, filers and OEM manufacturers during the entire production process to ensure the delivery of products with quality.

On November 15, 2021, the NMPA (National Medical Products Administration) 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. A complete medical device quality management system should be established by the OEM manufacturer, as well as meeting the requirements of the Good Manufacturing Practice for Medical Device.

Highlights

• Contract production in the Guideline refers to the production activities carried out by entrusted manufacturer (hereinafter referred to as “entrusted Party”) when they are entrusted by medical device registration or filing units(hereinafter referred to as “entrusting Party”).
• The guideline is not applicable to the following medical devices:
  • Implantable materials and artificial organs:
    1. Vascular stent and vascular stent system (except for peripheral vascular stent)
    2. Cardiac occluder, cardiac occluder system
    3. Artificial heart valve
    4. Plastic implant (agent)
  • Allogeneic medical devices
  • Some medical devices of animal origin:
    1. Repair materials for heart, nerve and dural
    2. Artificial skin
    3. Hemostatic and anti-adhesion materials used in human body
    4. Bone repair materials
    5. Other implantable medical devices directly created from animal tissues
  • Other medical devices:
    1. Pacemaker
    2. Implantable blood pump
    3. Implantable insulin pump.

• The guidelines defines the basic elements of the quality agreement for OEM production.
• The guideline provide the steps for protocol formulation and the principles and methods that should be considered in the protocol formulation.
• A template of the quality agreement is provided in the appendix of the guideline.

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. Read our separate blog post for more detailed information.

By Alice Liu and Jacky Li. If you would like support for drafting such agreements or for localization of your production in China, join our other customers and see what you’re missing out on by contacting us.