China GMP Medical Device 2022 Edition for sterile and implantable devices have been updated by the Beijing MPA on April 22, 2022, to replace the previous editions issued in 2016 with immediate effect:
- Good Manufacturing Practice (GMP) for Implantable Medical Devices (No.120-2022)
- Good Manufacturing Practice (GMP) for Sterile Medical Devices (No.121-2022)
China GMP Medical Device 2022 edition adds the following requirements:
- for OEM manufacturers and registrants to sign an OEM quality agreement specifying the obligations and responsibilities of both parties
- for enterprises to designate the department responsible for adverse event monitoring
- for management representatives to:
- build and maintain a well-established QMS,
- report QMS performance and identify room for improvements,
- raise staff’s awareness to comply with the Chinese law, rules and regulations, as well as to meet the customers’ expectations,
- fulfill the above requirements in alignment with the Guidelines for Management Representatives of Medical Device Manufacturers
- that inspection protocols should cover all technical parameters required by the Product Technical Requirements for quality control
- that raw material inspection, process inspection or periodic inspection can be carried out as non-factory inspection projects by a third-party inspection agency. However, it specifies that sterility testing, ethylene oxide (EO) residual testing, and bacterial endotoxins testing remain should not be carried out by a third-party.
China GMP Medical Device 2022 edition also amends:
- the detection method of ethylene oxide residue to be in line with the registered Product Technical Requirements. Methodological comparison with gas chromatography would be necessary if spectrophotometer detection is applied.
Concerning sterile medical devices in particular, the respective 2016 edition of the GMP originally indicated that the production of sterile medical devices included:
- darkroom operations,
- laser engraving,
- wielding,
- screen printing, etc.
This is now redefined in the 2022 edition to include:
- injection molding,
- extrusion,
- cleaning,
- drying,
- lyophilization,
- polymerization,
- polishing,
- bonding,
- welding,
- passivation,
- sterilization,
- heat treatment,
- primary packaging,
- aseptic processing, etc.
Concerning implantable medical devices in particular, the respective 2016 edition of the GMP originally indicated that the production of implantable medical devices included:
- darkroom operations,
- laser engraving,
- wielding,
- sandblasting, etc.
This is now redefined in the 2022 edition to include:
- casting,
- forging,
- injection molding,
- cleaning,
- spraying,
- drying,
- lyophilization,
- polymerization,
- polishing,
- passivation,
- sterilization,
- cutting,
- welding,
- primary packaging,
- virus inactivation, etc.
As China Regulatory and Registrations specialists, Cisema can assist you with the modification of your Quality Management System to Chinese standards as well as the writing of Product Technical Requirements (PTR) necessary for registration.
Cisema covers all your needs from clinical trials to product type testing, from legal agent to registration, from post-market compliance to in-China localization.
Send us your enquiry to see how we can help you.
By Julie Zhang and Jacky Li.
