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

CISEMA - China Certification, Purchasing and Quality Assurance

  • 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
  • About us
    • Partners
    • Company Profile
    • Testimonials
  • Locations
  • 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
    • Others
      • Publications
      • Online Shop
Contact
  • Home
  • News
  • News
  • NMPA Registration in China
  • Medical Device
  • Shelf Life for Passive Implantable Medical Devices: Draft Amendment Released

Shelf Life for Passive Implantable Medical Devices: Draft Amendment Released

Monday, 26 July 2021 / Published in Medical Device, News, NMPA Registration in China

Shelf Life for Passive Implantable Medical Devices: Draft Amendment Released

On June 10, 2021, the CMDE (Center for Medical Device Evaluation) of the NMPA (National Medical Products Administration) released the 2021 draft amendment of the guiding principles for the shelf-life of passive implantable medical device for registration and filing. The previous version of the guiding principles was issued in May 2017.  

Highlights

  • Consider how to set shelf life from the initial stage of the product development, and how to confirm the shelf life of the product continuously before and after selling into the market.
  • Validation tests of shelf life of medical devices usually include accelerated stability test, real-time stability test, etc.
  • The accelerated stability test design is based on the assumption that the chemical reactions involved in material deterioration follow the Arrhenius reaction rate function. However, not all the chemical reaction rates of materials conform to this function with the change of temperature. Many accelerated aging tests used in medical devices of polymer materials have been estimated based on the zero-order, first-order and pseudo-first-order chemical reactions of this equation.
  • Registered applicants are advised to set up multiple test observation time points (normally not less than 3) during the accelerated aging test. The zero-time performance data can be used as the reference index of the test items. The last observation point should be at least the same as the expected shelf life. Considering the complexity of changes in the real-world environment, it is recommended to set observation points longer than expected to declare shelf life.
  • The shelf life verification test of medical devices should be carried out with the same final products as the conventional production, and the packaging without products can be used for the verification of suitable items (such as packing tightness). Validation of the appropriate batch of products may be considered if the differences between batches may affect the results of shelf life verification. After the applicant has fully assessed the product and packaging material characteristics, sterilization process and other influencing factors, one batch of products may be selected for testing when appropriate.

By Colleen Xu. Contact Cisema if you would like to learn more.

Tagged under: Implants

What you can read next

From foreign- to China-made medical devices
medical device naming rules china
China Medical Device Naming Rules Updated
NMPA Annual Report

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
  • Publications
  • Seminars
  • Webinars

Recent Posts

  • clinical trials locally applied locally acting products

    New Guidelines on Clinical Trials of Locally Applied, Locally Acting Products

    Guidelines for clinical trials of locally appli...
  • medical device naming rules china

    China Medical Device Naming Rules Updated

    Medical device naming rules for China have been...
  • medical device qms audit

    Medical device QMS audit guidelines for product registration are open for comment

    China’s NMPA has issued draft guidelines on med...
  • china compulsory certificate

    Cisema Webinar: Certification in China – China Compulsory Certificate (CCC)

    The China Compulsory Certificate (CCC) is a man...
  • china gmp for pharmaceutical packaging

    China GMP for Pharmaceutical Packaging Materials (Draft for comments)

    A China Good Manufacturing Practices (GMP) on P...

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
Cookies on Cisema
Learn more about Cisema's Privacy Policy.