China Medical Device Filing and Registration

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What is the Definition of Medical Device？

Medical devices refer to instruments, equipment, utensils, in vitro diagnostic reagents and calibrators, materials and other similar or related articles directly or indirectly used in the human body, including required computer software; Its effect is obtained mainly by physical means, not by pharmacological, immunological, or metabolic means, or although these means are involved but only play an auxiliary role; Its purpose is to:

(1) Diagnosis, prevention, monitoring, treatment or remission of diseases;

(2) Diagnosis, monitoring, treatment, mitigation or functional compensation of injury;

(3) Testing, substituting, regulating or supporting physiological structures or processes;

(4) Life support or maintenance;

(5) Pregnancy control;

(6) To provide information for medical or diagnostic purposes by examining samples from human bodies.

According to the “Regulations on the Supervision and Administration of Medical Devices”, class I medical devices implement product filing management, and class II and class III medical devices implement product registration management. Before being put into the Chinese market, an application for filing or registration should be submitted to the corresponding drug regulatory authorities and a medical device filing certificate or registration certificate should be obtained. At the same time to ensure that the medical device production quality management system to carry out research and development and production and management activities.

Medical device classification and regulation in China

Class I medical device product filing process

Class I medical device product filing data requirements

Class I medical device filing form.
Associated documents (business license, enterprise qualification certificate, free sales certificate, etc.).
Product technical requirements.
Test reports.
Product specifications and minimum sales unit label design sample.
Manufacturing information.
Declaration of conformity, etc.

Class II medical device product registration process

Class II medical device product registration data requirements

1. Class II medical device registration form.

2. Associated documents (business license, enterprise qualification certificate, free sales certificate, etc.).

3. Product technical report.

4. Security risk analysis report.

5. Applicable product standards and descriptions.

6. Product performance self-test report.

7. Product registration test report issued by medical device testing institutions.

8. Clinical trial data of medical devices (if required).

9. Instructions for medical devices.

10. Effective certification documents of product production quality system assessment (certification).

11. The applicant shall provide a self-assurance statement on the authenticity of the materials submitted, etc..

Class III medical device product registration process

Class III medical device product registration data requirements