Provisions on the examination and approval of new medical devices (for Trial Implementation)

Article 1 In order to encourage the research and development of new medical devices, promote the healthy development of medical devices in China, and ensure the safety and effectiveness of new medical devices, these Provisions are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices. Article 2 The term "new medical device products" as mentioned in these Provisions refers to brand-new varieties that have not appeared in the domestic market or whose safety, effectiveness and product mechanism have not been recognized in China. Article 3 The State implements the examination and approval system for new medical devices.

New medical device products have passed the examination and approval of the State Medical Device Administration, and new medical device product certificates have been issued. The new product certificate of medical devices is not used as the approval document for products to enter the market. Article 4 A production enterprise may apply for product registration with a new product certificate. Article 5 The new product certificate of medical devices shall be uniformly printed by the State Administration of Medical Devices. The new product certificate number is:

National medical instrument (new) xxxx 1 No. X2XX3XXX4

These include:

XXXX 1 year certification

X2- Product Category

Xx3- Product Variety Code

Xxx4- serial number. Article 6 The State Pharmaceutical Products Supervision and Administration Bureau shall announce the approved new medical devices in a timely manner. Article 7 Before clinical trials of new drugs for medical devices, relevant materials shall be submitted to the State Pharmaceutical Products Supervision and Administration in accordance with the relevant provisions of the Measures for the Administration of Clinical Trials of Medical Devices, and clinical trials may be conducted only after examination and approval. Article 8 To apply for a new product certificate of medical devices, the following materials shall be submitted (in duplicate):

(1) product technical report. It should include the dynamic analysis of this kind of products at home and abroad, the biological performance, physical performance, chemical performance, technical performance and technological requirements of the products, as well as the basis, experimental process and results for determining the product performance indicators.

(two) product risk analysis and preventive measures.

(3) Novelty retrieval reports issued by national information or patent retrieval institutions.

(4) Product quality standards and preparation instructions approved by the State Administration of Pharmaceutical Products (for R&D units) or the pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government (for production units).

(five) product performance self-inspection report.

(six) the product type test report issued by the medical device quality inspection institution recognized by the State Administration of Medical Products.

(7) Approval documents for clinical trials.

(eight) clinical trial reports issued by two or more clinical trial bases.

(9) Instructions for use of the product. Article 9 After receiving the complete application materials, the State Pharmaceutical Products Supervision and Administration Bureau shall issue a notice of acceptance and make a decision on whether or not to approve it within 50 working days.

If it is not approved, it shall explain the reasons in writing. Article 10 If an applicant disagrees with the conclusion of examination and approval of the State Pharmaceutical Products Supervision and Administration, he may file an application for reexamination with the State Pharmaceutical Products Supervision and Administration within 30 days from the date of receiving the conclusion of examination and approval. Article 11 If a new product certificate is lost, the applicant may provide a statement of legal liability, and the supporting documents of the competent department of the unit and the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government may be reissued. The original number shall be used for the reissued certificate, and the word "supplement" shall be added. Article 12 Anyone who, in violation of these regulations, applies for a new medical device, provides false certificates, documents and samples, or obtains a new medical device certificate by other deceptive means, the State Administration of Pharmaceutical Products shall revoke his new product certificate and refuse to accept his new product application within two years. Article 13 The State Administration of Pharmaceutical Products shall be responsible for the interpretation of these Provisions. Fourteenth the provisions shall come into force as of April 20, 2000.