China-SFDA Medical Device

General Description

In order to enhance the supervision of Medical device and ensure its safety, efficiency and human health according to Regulations on Supervision and Management to Medical device (No. 276, State Council of the People's Republic of China), SFDA accepts the sales of
Medical device either manufactured in domestic market or imported from abroad by obtaining SFDA medical device registration compulsively.

Applicable product

SFDA Medical Device definition:
Any instrument, apparatus, implement, material or other article, including software, intended to be used, alone or in combination, for human beings for the purpose of : -prevention, diagnosis, treatment, monitoring or alleviation -diagnosis, treatment, monitoring, alleviation of or compensation for an injury or handicapped -investigation, replacement or modification, or support of the anatomy or of a physiological process -control of conception And which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in this function by such means.

Conformity assessment procedure

Medical device registration procedure of SFDA is as follows:

1. Classification;
2. product testing;
3. product registration (when testing result is passed).
4. certificate issuing.

The classification rule can be referred to www.sfda.gov.cn
Procedure:

1. Classification of Medical device

Medical device is classified on the basis of technic, structure, performance, guideline and usage. It can be classified as Class I, Class II, Class III according to the product risk. Class I product has the lowest risk and Class III has the highest risk.

2. Testing process of medical device


• Application for the product registration standard（in Chinese）
• Reviewing the product registration standard
• Application for the Type Examination in China（Domestic medical device / Imported medical device – belong to Class II, Class III）
• Type Examination
  When applying for registration of Class II and Class III medical device, the product test must be performed in the testing institute accredited by SFDA.
• Clinical trials（Imported medical device- Class Ⅲ Implantable medical device） There’s no “Exempt” of clinical trials for Class III medical device. Clinical trials shall be performed according to Annex 12 of (Registration Management Method of Medical Device), requirement of (Clinical Trials Data Classification Rule of Medical Device Registration), product Classification and the practical situation of manufacturer.
3. Registration process of Medical device


• Submitting registration files（the registration can be started when obtaining test report and clinical test report (if applicable)）
• Document reviewing and evaluation（Test report and related documents reviewing）
• Admin checking and approval（Approval after checking the application data, test report and clinical test report conform to related regulation）
• Registration certificate issuing (Issuing related Medical device registration certificate, and the certificate’s period of validity is 4 years.)