• 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
  • Cisema experts cited in drug-device combination news

Cisema experts cited in drug-device combination news

drug-device
Thursday, 09 September 2021 / Published in Medical Device, News, NMPA Registration in China

Cisema experts cited in drug-device combination news

Cisema’s regulatory affairs consultant Anna King was recently cited by Bioworld in their article titled “China clarifies rules for registration and classification of drug-device combinations”.

Mrs King and Stephen Sunderland from LEK Consulting LLC gave their views on the recent clarification from NMPA regarding drug-device combination products.

“Before the new regulation, a manufacturer had to try their luck and decide themselves whether they should submit their application to the technical review body for drugs CDE or the technical review body for medical device CMDE,” said King.

“With the new regulation, the procedure and responsibility are very clear now,” she said.

We have published more about the recent NMPA announcement in our blog post “New Preconditions for Marketing Approvals of Combination Products in China”.

Contact Cisema if you would like to learn more.

Tagged under: Combination Products, Drug - Medical Device Combination, Drug device combination products

What you can read next

15 Years in China Business
innovative-provisions-for-cosmetics-in-pudong-shanghai
Innovative provisions for cosmetics in Pudong, Shanghai now in force
Clinical Trials GMP management
Overseas clinical trial data for IVD registration in China – Technical guidelines issued

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

  • Children cosmetics technical guidelines in China

    Children cosmetics technical guidelines in China – Newly issued by NIFDC

    Children cosmetics technical guidelines in Chin...
  • pH Determination Method

    China’s cosmetic safety technical specifications – 21 revision items issued

    China’s cosmetic safety technical specifi...
  • laser therapy devices

    Clinical evaluation of laser therapy devices – New guidelines issued

    Clinical evaluation of laser therapy devices ha...
  • dental implant system

    Clinical evaluation of dental implant systems in China – New guidelines issued

    Clinical evaluation of dental implant system ha...
  • China Medical Device Webinar

    China Medical Device Webinar with AdvaMed Accel for U.S. exporters

    The China Medical Device Webinar will be featur...

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

© 2003-2023 Cisema. All rights reserved.

TOP