• 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
  • 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
    • Newsletter Sign Up
    • Others
      • Publications
      • Online Shop
Contact
  • Home
  • News
  • News
  • NMPA Registration in China
  • Medical Device
  • Regulatory Updates for Implant Products in September 2021

Regulatory Updates for Implant Products in September 2021

Monday, 25 October 2021 / Published in Medical Device, News, NMPA Registration in China

Regulatory Updates for Implant Products in September 2021

On September 6, 2021, the CMDE (Center for Medical Device Evaluation) of the NMPA (National Medical Products Administration) released a draft version of the technical review guideline on the quality homogeneity of metallic implants using additive manufacturing.

The product scope covers metal implants that can be customized to patients using powder bed fusion (PBF) in the manufacturing process. The guideline listed out basic requirements for research studies on performance:

1. The applicant shall evaluate or compare the consistency of the product in terms of chemical composition, geometric structure, microstructure and mechanical properties. Specifically, it includes chemical composition, size, porous structure, internal quality (defects, metal powder residues, etc.), microstructure, surface quality (surface defects, surface roughness), dynamic and static mechanical properties (shear properties, compression properties, tensile properties, bending properties, torsion properties), corrosion resistance, metal ion precipitation, etc.

2. The applicant shall describe the typical factors that may cause uneven quality in terms of software, equipment, powder raw materials, additive manufacturing process and post-treatment process, personnel, etc. used in additive manufacturing, and explain the influencing factors, possible risks, quality control indicators, etc.

On September 3, 2021, the NIFDC (National Institute for Food and Drug Control) released (No.14-2021) the draft version of the following YY standards:

  1. YY 0315-XXXX – Wrought titanium and titanium alloy dental implants
  2. YY 0272-XXXX – Dentistry-Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements
  3. YY/T XXXX-XXX – Dentistry-Pre-capsulated dental amalgam

The YY standards were drafted by the Dental Instrument Inspection Center of the Peking University Hospital of Stomatology to replace the original YY 0315-2016 and YY 0272-2009. The draft documents provide definitions, performance requirements, corresponding test methods and specifications for the contents to be indicated on the packaging and marking.

Also, read our blog post about the 2021 draft amendment of the guiding principles for the shelf-life of passive implantable medical device for registration and filing released by the CMDE in June 2021.

Dental instruments and passive implants devices were both on the top five product groups of foreign origin to be registered in China in 2019 and 2020. We expect related new measures will be implemented as China continues to focus on strengthening the regulatory framework and market supervision of products belonging to these groups.

By Judith Sun, Colleen Xu, and Jacky Li. Contact Cisema if you would like to learn more.

Tagged under: dental implants, Implants, metallic implants, YY standards

What you can read next

Recalls of Medical Device Regulation Updated
Various Technical Review Guidelines Updated
Webinar: MedTech pathway to China: Market opportunities, regulatory hurdles and recent updates

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

  • China cosmetics efficacy claims FAQ

    China cosmetics efficacy claims FAQ available to answer key questions

    China cosmetics efficacy claims FAQ is availabl...
  • China cosmetics GMP inspections

    China cosmetics GMP inspections points have been finalised

    China cosmetics GMP inspections points and judg...
  • China medical device quality safety responsibility

    China medical device quality and safety responsibility regulations come into force on March 1, 2023

    China medical device quality and safety respons...
  • China drug standards draft measures

    China drug standards draft measures have been published by the NMPA

    China drug standards draft measures have recent...
  • China special equipment safety supervision

    China special equipment safety supervision – draft provisions released

    China special equipment safety supervision regu...

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.