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Inspection, supervision and administration of imported medical devices

The General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (AQSIQ) is in charge of the inspection, supervision and administration of imported medical devices throughout the country, responsible for organizing the collection and sorting of risk information and risk assessment related to imported medical devices, and taking risk warning and rapid response measures. The entry and exit inspection and quarantine institutions (hereinafter referred to as inspection and quarantine institutions) set up by AQSIQ are responsible for the inspection, supervision and administration of imported medical devices within their jurisdiction, the collection of risk information related to imported medical devices and the specific implementation of rapid response measures.

The registration of imported medical devices shall be handled according to Article 11 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 650 of The State Council) : to apply for the registration of category II medical devices, the registration applicant shall submit the registration application materials to the food and drug regulatory department of the local people's government of the province, autonomous region or municipality directly under the Central Government. To apply for registration of category III medical devices, the registration applicant shall submit registration application materials to the food and drug regulatory authority under The State Council.

To export category ii and class iii medical devices in our country's overseas production enterprise, should by its representative offices established in the territory of China or designated enterprise as a legal person as agent within the territory of China, to the food and drug supervision and administration department under the State Council shall submit an application for registration information and registration of the applicant's country (region) permitted by the competent department of the medical equipment market. The product inspection report in the application materials for registration of Category II and Iii medical devices shall be the inspection report issued by the medical device inspection institution. Clinical evaluation data shall include clinical trial reports, except for medical devices exempted from clinical trial in accordance with the provisions of Article 17 of these Regulations.

List of documents required for registration of class II and III imported equipment

The product registration service items for imported medical devices are the same as those for domestic products.

I. Application Form

2. Supporting documents

1. Certification documents of the country of origin allowing the product to be marketed and sold.

2. Production enterprise qualification documents.

3. A copy of the power of attorney, the letter of commitment of the agent and a copy of the business license or the registration certificate of the agency.

List of basic requirements for safety and effectiveness of medical devices

4. Review data

5. Research data

6. Manufacturing information

7. Clinical evaluation data

8. Product risk analysis data

9. Product technical requirements

10. Product inspection report

Product specification and label sample of minimum sales unit

Declaration of conformity

Inspection, supervision and administration of imported medical devices

List of documents required for registration of class II and III imported equipment

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