Regulatory Affairs

Regulatory Affairs

China - worldwide Approval of Medical Devices

Medical Devices for the Chinese market

With almost 1.4 billion people, the Chinese market is by far the largest in the world. It attracts large sales, but cannot be conquered overnight. Language barriers, long Approval times and non-transparent decisions are just some of the challenges that European manufacturers of Medical Devices face in China.

China - worldwide Approval of Medical Devices

Medical Devices for the Chinese market

With almost 1.4 billion people, the Chinese market is by far the largest in the world. It attracts large sales, but cannot be conquered overnight. Language barriers, long Approval times and non-transparent decisions are just some of the challenges that European manufacturers of Medical Devices face in China.

Challenges in the Approval of Medical Devices in China - Are you aware?

We are certain that you are aware of the difficulties accompanied with the Medical Devices Approval process. Besides obstacles like language and cultural barriers, manufacturers are often discouraged by many different factors such as:

  • The official structures and thus also the regulatory framework are constantly changing. For example, in 2018 the CFDA (China-FDA) was replaced by the NMPA (National Medical Product Administration) and a new classification system was introduced.
  • There are many individual national GB and YY standards that come quickly, are changed and need to be taken into account.
  • It is requested that you disclose proofs and documents that reveal your product in depth.
  • Your products must be re-tested in the national test centers. These tests are very specific, burdensome and time/cost intensive.
  • Many decisions from the authorities are accompanied by fruitful waiting times. Often their decisions are puzzling and are not always based on the applicable regulations.
 

Our expert knowledge for your success

We have in-depth, worldwide expertise in the Approval of Medical Devices. I will answer your questions about the MDR and put together a team for your project upon request.

Contact +49 451 808 503 60

qtec as your partner

Our experts:

  • Know the special Chinese culture
  • Are always up to date with national requirements
  • Know the advantages and requirements of the new Electronic Regulated Product Submission (eRPS)
  • Help you to minimize queries from the authorities
  • Enable you to reduce the time required for the Approval of your Medical Devices

With our native chinese speakers, we are also able help you with difficult communications and the creation of clinical evaluations, life-cycle or cybersecurity reports for China. Our Chinese experts know how to meet the local requirements without revealing too much know-how.

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