The CFDA (China Food and Drug Administration) is the highest administrative authority responsible for the registration and certification of medical devices and medical devices. It belongs to the Chinese Ministry of Health (MOH), the administrative body responsible for all medical health care in China.

Medical devices are classified by the CFDA in three different categories. The three classifications are marked Class I, Class II and Class III. Each category may require specific administrative procedures, product testing and / or even clinical trials.

- For Class I devices, safety and efficacy can be ensured through routine administration, so that product testing and clinical trials in China are usually not required.

- For Class II devices, safety and efficacy can be ensured through routine administration and product testing. Some devices also require clinical testing to gain regulatory approval for the Chinese market.

- Class III devices implanted in the human body or used to support or sustain life pose a potential risk to the human body and are strictly controlled through mandated tests and clinical trials to ensure safety and efficacy.

News

New Implementation Regulation CNCA-C11-01... New Implementation Regulation CNCA-C11-01 for Vehicle released 04-25-2020 -  on the 17 april 2020, a new implementation regulation CNCA-C11-01: 2020 for Vehicle was released...
Business Scopes of China CCC Certification... Business Scopes of China CCC Certification Bodies updated 09-14-2019 -  CNCA released china ccc certificaiton bodies for explosion protection products and Household...
10 new chinese GB Standards released 10 new chinese GB Standards released 08-16-2019 - According to a recent press from the State Council of P.R.C, 10 new GB Standards ("GB", "GuoBiao")...
Explosion protection products CCC releva Explosion protection products CCC relevant 07-17-2019 - according to a recent announcement of CNCA, explosion protection products are CCC relevant from 01...
374 new and revised GB Standards release 374 new and revised GB Standards released 07-09-2019 - According to a recent press from the State Council of P.R.C, 374 new and revised GB Standards ("GB",...
173 new and revised GB Standards release 173 new and revised GB Standards released 06-16-2019 - According to a recent press from the State Council of P.R.C, 173 new and revised GB Standards ("GB",...
business scopes of accredited testing laboratories... business scopes of accredited testing laboratories for CCC products updated 05-30-2019 - according to a recent announcement of CNCA, business scope of the following accredited testing laboratories...
Geely set up engineering R & D center in... Geely set up engineering R & D center in Germany 05-18-2019 - According to the China News Service Beijing on May 16 that the research and development center set...
Implementation Rules for Urban Rail Transit... Implementation Rules for Urban Rail Transit Equipments Released 05-06-2019 - According to a recent announcement from the China Certification and Accreditation Administration ("CNCA"),...
business scopes of test laboratories for... business scopes of test laboratories for China CCC products updated 04-29-2019 - business scopes of selected test laboratories for China CCC products were updated and released by...

Support

Unterstützung

You work at your pace. You can handle your projects independently via our portal, as well as inquire about personal support. We have therefore committed ourselves to give you the opportunity to design your own processes, without having to give up the support through our portal through us

Online Administration

Online Verwaltung

We offer you the opportunity to carry out your certification processes yourself, but without having to forego the know-how or the support of experienced employees. The online system is designed for a variety of certifications and offers you also FAQ lists, as well as ready-made forms and tables, as well as a module to clarify open questions with one of our employees.

Change Certification

Change Certification

In our fast time changes in business life are a constant accompaniment. Fixed structures that used to build up over many years can now be smashed very quickly. There are internal and external reasons for this. The CS gives an overview of the conformity during changes.

Cooperation

Kooperationen

Since we all only have a limited time and financial capacity, and want to offer the customer a comprehensive service, cooperations only make sense among related organizations. These have a reliable structure, as well as a good interpersonal harmony.

Go to top