State Drug Administration Order

Number 17

       The Provision on New Medical Device Approval (Interim) herein issued was discussed and approved on February 17, 2000 by the Bureau Commission of the State Drug Administration and go into effect April 20, 2000.

Bureau Director: Zheng Xiaoyu

April 10, 2000

Provision on New Medical Device Approval

(Interim)

Article 1 This provision has been formulated in accordance with the Regulation for the Supervision and Administration of Medical Device and are enacted to encourage the research and development of new medical devices, promote the healthy development of China’s medical device industry and ensure the safety and effectiveness of new medical device.

Article 2 "New medical device" refers to the kind of brand new product varieties which have not been available in the domestic market, or for which the safety, effectiveness and product mechanism have not been recognized domestically.

Article 3 The state shall carry out new medical device evaluation and approval procedure they can be sold in the Chinese market. After the State Drug Administration (hereafter referred to as “SDA”) has approved a new product, it shall receive a New Product Certificate for medical device. Receipt of this certificate cannot be considered as acquisition of approval for sale in the market.

Article 4 The manufacturing enterprise can use the New Product Certificate to apply for product registration.

Article 5 All New Product Certificates are printed by the SDA. The certificate number is as below shown:

GYGX (new) XXXX₁ No. X₂XX₃XXX₄

XXXX₁ is the year of approval

X₂ is the product classification

XX₃ is the code for the product family

XXX₄ is the serial number for the certificate

Article 6 SDA shall promptly publish a notice for approved new medical device.

Article 7 Before clinical trials for a new product can be carried out, the relevant documentation, as required by the Management Methods for the Medical Device Clinical Trials, must be submitted to the SDA. Only after SDA’s evaluation and approval, can the clinical trials be started.

Article 8 The following documentation is required to apply for a certificate for a New Product Certificate for medical device (in duplicates):
      a. Product technical report. The report should include dynamic analysis of this type of product from China or another countries, biological properties, physical properties, chemical properties, technical specifications and technical requirements for manufacturing process and recognized references and testing process and results for the technical indices.
      b. Product risk analysis and precaution. Report of new product investigation issued by national level information agency or patent examination agency.
      c. Product quality standards and explanation of their determination recognized by the (for research and development institution) or by local SDA in respective province, autonomous region or municipal city (for manufacturing enterprise)
      d. Product performance report prepared by the enterprise.
      e. Type test report of the product issued by a supervision and inspection center for medical device recognized by the SDA
      f. Document approving clinical trials.
      g. Reports on clinical trials issued by at least two clinical trial sites.
      h. Instructions for use of the product.

Article 9 SDA will notify the applicant upon receipt of all documentation for the application by an Application Acceptance Notice and decide on the application within fifty working days after the notice is issued. If the application is denied, SDA will notify the applicant of the reasons in written.

Article 10 If the applicant holds a different view towards SDA’s decision concerning the conclusion of an application evaluation, the applicant can submit a second application within thirty working days upon receipt of the decision from SDA.

Article 11 If the New Product Certificate is lost, the applicant may instead submit a declaration for undertaking related legal liability, a certificate of proof from the department of the enterprise responsible and a certificate of proof from the local SDA of the province, autonomous region or municipal city. The new documents should use the number from the lost New Product Certificate followed by the letter “B.”

Article 12 SDA will revoke a New Product Certificate if it is discovered that the applicant violated these Provision in the application process by submitting falsified certificates, documents or samples or by other fraudulent means. For a period of two years following such incident SDA will not accept another application for New Product Certificate from the applicant.

Article 13 SDA is responsible for the interpretation of this provision.

Article 14 This provision goes into effect from April 20, 2000.   

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