• EnglishEnglish
    • Deutsch Deutsch
    • Italiano Italiano
    • Français Français
    • 日本語 日本語
    • 한국어 한국어

CISEMA - China Zertifizierung, Einkauf und Qualitätssicherung

  • Services
    • NMPA Registration – Medical Devices and IVDs
    • NMPA Registration & DMF – Pharmaceuticals
    • NMPA Registration – Cosmetics
    • NMPA Registration – Health Food
    • CML (China Manufacture Licence) – Pressure vessels
    • CCC (China Compulsory Certification) – Industrial and consumer goods
    • Others
      • Sourcing and Quality Control
      • Logistics and Customs Support
      • Sales Support
  • Events
    • Trade Fairs & Conferences
    • Seminars
    • Webinars
  • News & Knowledge
    • Regulatory News
      • Medical Devices and IVDs
      • Cosmetics
      • Pharmaceuticals & DMF
      • CCC
      • Pressure Vessels
    • Whitepapers
    • FAQ – NMPA Registration – Medical Devices and IVDs
    • Newsletter Sign Up
    • Others
      • Publications
      • Online Shop
  • About us
    • Partners
    • Company Profile
    • Testimonials
  • Locations
  • Newsletter Sign Up
Contact
  • Home
  • News
  • News
  • NMPA Registration in China
  • Medical Device
  • China GMP Medical Device 2022 Edition for Sterile and Implantable Devices

China GMP Medical Device 2022 Edition for Sterile and Implantable Devices

china gmp for sterile and implantable
Tuesday, 24 May 2022 / Published in Medical Device, News, NMPA Registration in China

China GMP Medical Device 2022 Edition for Sterile and Implantable Devices

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.

GET IN TOUCH

🌐 Send us your enquiry
📚 Request our whitepapers

What you can read next

Public Consultation for the Directory of Claimed Health Functions Permitted for Health Food (I)(2019)
NMPA Solicits Public Opinions on the Reclassification of IVD Reagents
CBEC (Cross Border E-Commerce) – Deliveries Classified as Products for Personal Use

Search

Categories

  • Fairs & Events
  • News
    • CCC
    • CEL
    • CML, SELO
    • Medical Devices Listing in Hong Kong
    • NMPA Registration in China
      • Cosmetics
      • Health Food
      • Medical Device
      • Pharmaceuticals & DMF
    • RoHS
    • Voluntary Product Certification
  • Publications
  • Seminars
  • Uncategorized
  • Webinars

Recent Posts

  • Submission of safety information for cosmetics ingredients

    Submission of safety information for cosmetics raw materials – Draft guidelines issued

    Submission of safety information for cosmetics ...
  • avoid animal testing in Chinaweb-2023

    How to avoid animal testing in China for cosmetics | Cisema Webinar

    China’s beauty and cosmetic market has be...
  • guidelines for medical devices registration

    Guidelines for medical devices registration in China – New development plans in 2023

    Guidelines for medical devices registration in ...
  • China DMF of API

    China DMF of API, Excipient & Packaging Materials: Market & Regulatory | Cisema Webinar

    “China DMF of API, Excipient & Packag...
  • pre-phase III drug clinical trial meeting guidelines

    Pre-phase III drug clinical trial meeting guidelines released

    Pre-phase III drug clinical trial meeting guide...

Archive

Cisema

With twelve locations and over ninety highly qualified employees, Cisema can offer you optimal support in China.

Services

  • Certification
  • Sourcing and Quality Control
  • Logistics and Customs Support
  • Sales Support

Dialogue

  • Contact us
  • Newsletter Signup
  • Events
  • News & Knowledge
  • Partners

Company

  • GTC
  • Privacy Statement
  • Legal Notice
  • About us
  • Locations
  • GET SOCIAL

© 2021 Cisema. All rights reserved.

TOP