State Drug Administration Order

Number 16

     The Provisions on Medical Device Registration were examined and passed by the State Drug Administration on March 27, 2000 and shall go into effect April 10, 2000.

Director General: Zheng Xiaoyu

April 5, 2000

Provision on Medical Device Registration

Chapter I. General Principles

Article 1 These provisions were formulated in accordance with Regulations for the Supervision and Administration of Medical Device to regulate the registration and management of medical device and ensure the safety and effectiveness of medical device.

Article 2 All medical devices for sale and use within the borders of China must be registered in accordance with the provisions. Any such equipment or supplies that have not been so registered must not be sold or used in China.

Article 3 Medical devices shall be registered by classification in China.

Registration application of Class I medical devices manufactured by domestic enterprises shall be inspected by the Drug Administration of the municipalities consisting of districts. A registration certificate shall be issued for the product upon approval.

Registration application of Class II medical devices manufactured by domestic enterprises shall be inspected by the Drug Administration of provincial level. A registration certificate shall be issued for the product upon approval.

Registration application of Class III medical devices manufactured by domestic enterprises shall be inspected by the State Drug Administration. A registration certificate shall be issued for the product upon approval.

Registration application of medical devices manufactured by overseas enterprises shall be inspected by the State Drug Administration. A registration certificate shall be issued for the product upon approval.

Medical devices manufactured by domestic enterprises refer to those products of which the final manufacturing processes are completed within the borders of China.

Medical devices manufactured by overseas enterprises refer to products of which the final manufacturing processes are completed outside the borders of China.

The registration of products made in Taiwan, Hongkong and Macao for sale and use within the borders of Mainland China shall be inspected by the State Drug Administration. A registration certificate shall be issued upon approval.

Article 4 Medical device registration certificates shall be printed uniformly by the State Drug Administration.

    (1) Class I products by domestic enterprises can be directly applied for the manufacturing permit registration. For Class II and Class III products by domestic enterprises, initial registration can be made for only trial production, the certificate of which is valid for two years. Seven months upon trial production registration completion, application may be made for manufacturing permit registration, the certificate of which is valid for 4 years.

Formation of the registration number:

X₁ YGX (X₂ ) XXXX₃ No. X₄XX₅XXXX₆

X ₁ is the abbreviation for the location of the registering agency (national; provinces, autonomous regions or municipalities directly under the central government; or province, autonomous region plus municipality divided into districts);

X₂ is the type of registration (trial production or manufacturing permit).

XXX X₃ is the year of registration.

X₄ is the product classification.

X X₅ (for trial production) is the date of expiration of registration and

(for manufacturing permit) is the code for the product variety.

XXX X₆ is the registration serial number.

The registration certificate is attached with Medical Device Product Manufacture Recognition Form, which is to be used with the registration certificate.

    (2) Product Registration Certificate for products manufactured by enterprises outside the borders of China is valid for four years.

Formation of the registration number:

SDA (I) XXX X₁No. X₂ X X₃XXXX₄

XXX X₁ is the year of registration.

X₂ is the product classification.

X X₃ is the code for the product variety

XXX X₄ is the registration serial number.

The registration certification is attached with the Registration Form for Medical Device, which is to be used with the registration certificate.

Chapter II Registration of Domestic Medical Device

Article 5 For the registration of Class I medical device manufactured by domestic enterprises, the manufacturing enterprise must submit the following documentation:
   1. Qualification certification for medical device manufacturing enterprise.
   2. Product specifications and explanation of their determination.
   3. Self-test Report on all the properties and functions of the product
   4. Explanation of the current state of resources available with the enterprise for product manufacturing and quality control (including testing methods).
   5. Instructions for use of product.
   6. Self-declaration by the enterprise to guarantee the truthfulness of the documentation submitted.

Article 6 For the registration of Class II and Class III medical device manufactured by domestic enterprises for trial production, the following documentation must be submitted:
   1. Qualification certification for medical device manufacturing enterprise.
   2. Product technical file.
   3. Safety and risk analysis report.
   4. Product specifications and explanation of their determination.
   5. Self-test Report on all the properties and functions of the product
   6. Type test report issued within 1 year before the registration application for trial production (biological materials test should be carried out within 6 months before the start of clinical trials) by a test center recognized by the State Drug Administration.
   7. Clinical trials report from at least two clinical trial sites. The format of the reports must be in accordance with the Sub-provisions on Clinical Trials Report for Medical Device Registration (see appendix). The clinical trials shall be carried out in accordance with the Provision on Medical Device Clinical Trials.
   8. Instructions for use of product.
   9. Self-declaration by the enterprise to guarantee the truthfulness of the documentation submitted.

Article 7 For the registration of Class II and Class III medical device manufactured by domestic enterprises for trial production, the following documentation must be submitted for manufacturing permit, the manufacturing enterprises must submit the following documentation:
   1. Qualification certification for medical device manufacturing enterprise.
   2. Copy of trial production registration certificate.
   3. Product specifications.
   4. Product improvement report during the period of trial production.
   5. Valid certificate for quality system (recognition certificate) of the enterprise.
   6. Type test report issued within 1 year before the registration application for manufacturing permit by a test center recognized by the State Drug Administration.
   7. Product quality tracking report
   8. Self-declaration by the enterprise to guarantee the truthfulness of the documentation submitted.

Article 8 Six months before the expiration of product manufacturing permit expiration, application shall be made to re-register the product.
 1. For the re-registration of Class I medical device, the following documentation shall be submitted:
   1. Qualification certification for medical device manufacturing enterprise
   2. Copy of previous manufacturing permit
   3. Product specification
   4. Product quality tracking report.
   5. Self-declaration by the enterprise to guarantee the truthfulness of the documentation submitted.
 2. For the re-registration of Class II and Class III medical device, the following documentation shall be submitted:
   1. Qualification certification for medical device manufacturing enterprise
   2. Copy of previous manufacturing permit
   3. Type test report issued within 1 year before the registration application for manufacturing permit by a test center recognized by the State Drug Administration.
   4. Valid certificate of quality system audit (recognition certificate) of the enterprise.
   5. Product specifications and explanation of their determination.
   6. Product quality tracking report.
   7. Self-declaration by the enterprise to guarantee the truthfulness of the documentation submitted.

Article 9 Enterprise applying for registration of Class II and III medical device manufacturing permit shall pass quality system audit. Quality system audit shall be carried out in accordance with the Provisions on Quality System Audit for Medical Device Manufacturing Enterprises.

Article 10 For products, which meet either of the following conditions, application may be directly made for manufacturing permit after supplementary documentation submission required for product trial application.
   1. The enterprise has already acquired GB/T19001 and YY/T0287 or GB/T19002 and YY/T0288 (Quality System—Special Requirements Applicable to Medical Device) recognition certificates issued by a quality system recognition agency designated by the State Drug Administration. In addition, the product for which registration for manufacturing permit is being applied must be in the same product type as a product that has already been registered for manufacturing permit.
   2. The difference in configuration and functions between the product for which registration for manufacturing permit is being applied and a similar product that is already registered for manufacturing permit is insignificant in terms of safety and effectiveness.

Chapter III. Registration of Medical Device

Manufactured Outside of China

Article 11 The following documentation is required for the registration of medical device manufactured outside of China:
    1. Legal Qualification certification for medical device manufacturing enterprise
    2. Qualification Certification of applicant.
    3. Document proving that the government in the country of origin (or regions such as Taiwan, Hong Kong or Macao) has approved the product to be sold as medical device in the market of that country or region.
    4. Product technical specifications which refer to the requirements for safety and technical functions of the product to be registered and the corresponding testing methods (two copies required for Class III products).
    5. Product instructions for use.
    6. Type test report issued within 1 year before the registration application by a test center recognized by the State Drug Administration. (applicable to Class II and Class III products).
    7. Medical device clinical trials report. The format of the reports must be in accordance with the Sub-provisions on Clinical Trials Report for Medical Device Registration (see appendix). The clinical trials shall be carried out in accordance with the Provision on Medical Device Clinical Trials.
    8. Product Quality Guarantee issued by the manufacturer certifying that the quality of the product to be registered for sale in China is exactly the same as that of the product marketed in the country (region) of origin.
    9. Letter of Authorization for designated after-sales service agency in China and Letter of Undertaking and business license of the authorized agency
   10. Self-declaration by the enterprise to guarantee the truthfulness of the documentation submitted.

The above documentation shall have Chinese versions. Copies of documents, which must carry the signature and stamp of the issuing agency or be notarized by local notarized body, may be submitted for Item 1 through 3. All other documents must be the originals and carry the seal or signature of the legal representative of the enterprise

Article 12 Six months before the expiration of the registration certificate for imported medical devices, the following documentation needs to be submitted for product re-registration:
    1. Qualifications certificate of the applicant.
    2. Copy of old registration certificate.
    3. Document proving that the government in the country of origin (or region) has approved the product to be sold as medical device in the market of that country or region.
    4. Product technical specifications which refer to the requirements for safety and technical functions of the product to be registered and the corresponding testing methods (two copies required for Class III products).
    5. Product instructions for use. Type test report issued within 1 year before the registration application by a test center recognized by the State Drug Administration. (applicable to Class II and Class III products).
    6. Product quality tracking report.
    7. Product Quality Guarantee issued by the manufacturer certifying that the quality of the product to be registered for sale in China is exactly the same as that of the product marketed in the country (region) of origin.
    8. Letter of Authorization for designated after-sales service agency in China and Letter of Undertaking and business license of the authorized agency
    9. Self-declaration by the enterprise to guarantee the truthfulness of the documentation submitted.

Article 13 An on-site inspection of the production quality system is required for registration of Class III medical device manufactured by an enterprise outside the borders of Mainland China. The cycle time of on-site inspection of quality system is valid for four years. If the quality system for the same type of product has been inspected and approved within the same cycle, the on-site inspection need not be repeated for new registration application.

Chapter IV Management of Medical Device Registration

Article 14 The Drug Administration of the municipalities consisting of districts shall decide within thirty working days upon receipt of all required documentation whether or not to approve a registration application.

The Drug Administration of provincial level shall decide within sixty working days upon receipt of all required documentation whether or not to approve a registration application.

The State Drug Administration shall decide within ninety working days upon receipt of all required documentation whether or not to approve a registration application (exclusive of the time required to carry out an overseas on-site inspection of the quality system).

A written explanation of rejection reasons shall be issued for an application rejection.

Registration acceptance department shall issue Acceptance Notification upon receipt of full documentation and start the time count for documentation evaluation period.

If the applicant is informed to provide additional documentation or clarification of a certain question during documentation evaluation, the time required to respond to the request is not included in the time count for documentation evaluation period.

Article 15 An enterprise may apply for an exemption from type test if the applied medical device meets all of the following conditions:
    1. For a domestic enterprise, the enterprise has already acquired GB/T19001 and YY/T0287 or GB/T19002 and YY/T0288 recognition certificates issued by a quality system recognition agency designated by the State Drug Administration. In addition, the approved quality system covers the product being applied for registration.

For a product manufactured by an enterprise in another country or region, the enterprise has received and still has a valid market approval from the government agency of country of origin. In addition, the enterprise has acquired the recognition of its quality system based on ISO 9000 (or equivalent) series standard.
    2. The difference in configuration and functions between the applied product and a similar product that is already registered is insignificant in terms of safety and effectiveness.
   2. The product being applied is not an implantable device.
   3. The product being applied does not contain radiation source.
   4. The malfunction of the product, if any, shall not result in death or serious injury to the user or operator of the product.

Article 16 The instructions for use of the product should be examined and approved according to Provisions on Instructions for Use, Labeling and Packaging Indication of Medical Device. Upon approval of the instructions for use, no unauthorized amendment is permitted. Adding indication for use or expanding the scope of product application shall require a new application for registration.

Article 17 The classification medical device registration unit shall be based the differences in product technical configuration and functional specifications.

Article 18 For a product, which meant to be used in conjunction with other devices, registered as a component, the enterprise shall state the specifications or model number of recommended products, components or assemblies to be used together. For an assembly consists of components that have already been registered individually, the entire assembly shall be re- registered as a system.

For an assembly of components registered as a system, a list of main components shall be provided. In the case of any change in the specifications of one of the components, application shall be made to re-register the entire system.

If a component of an assembly that is registered as a system is to be sold separately, it does not require a separate registration.

Article 19 The procedures for amendment or supplementing a registration certificate are as below shown:
     1. In the case of manufacturing enterprise name change or merge with another enterprise, etc., change of enterprise name in the registration certificate is required. The application letter, the new business license and the certificate from the local drug administration shall be submitted to complete the registration certificate amendment procedures within 30 working days of the change.
     2. In case of product name change, but no change in the product itself, an application letter needs to be submitted to complete completed to registration certificate amendment procedures.
     3. In the case of loss or damage of the registration certificate, an application letter and a declaration of legal liability undertaking shall be submitted to apply for a new registration certificate.
     4. Manufacturing site change, though with no change in the company or the product itself, is not covered in the scope applicable to registration certificate alternation. The product shall be re-registered following the same procedures as its previous registration. A valid certification for production quality system audit (recognition) is required to be submitted for the registration application.

Article 20 If a registration certificate is altered, the original number is adopted with the word “amendment” in parentheses added at the end of the original number to indicate the alternation. The date of issue shall be the date the amendment is approved and the term of validity will be the same as the original registration, specified as “expires YY/MM/DD.” The original registration certificate shall be retracted when a new certificate is issued.

Article 21 The registration certificate is automatically invalidated if a medical device is out of production for over two consecutive years. If the enterprise intends to resume production, the product shall have to be re-registered.

Article 22 The management of the registration of medical device acquired from re-sale is covered under other provisions.

Article 23 A medical institution may develop medical devices for patient treatment, but the device cannot be mass manufactured during the research and development period. Such devices can only be used within the institution where it was developed and the institution shall receive a product use permit with the validity for two years. The institution shall apply for registration for manufacturing permit upon expiration of use permit according to registration evaluation and approval procedures.

Application for Class II products should be submitted to drug administration of provincial level and application for Class III products should be submitted to the State Drug Administration. The following documentation shall be submitted for the application:
     1. Qualification certificate of the medical institution.
     2. Product specifications.
     3. Type test report issued within 1 year before the registration application by a test center recognized by the State Drug Administration.
     4. Clinical trials Report
     5. Instructions for use.
     6. Declaration of legal liability undertaking for the product from the hospital.
     7. Self-declaration to guarantee the truthfulness of the documentation submitted.

Article 24 All the drug administration of the municipalities consisting of districts shall submit a report to drug administration of the provincial level every three months for product registration statistics. All drug administration of provincial lev el shall submit a report to the State Drug Administration every three months for product registration statistics. The State Drug Administration shall regularly publish medical device registration bulletin.

Chapter Ⅴ Penalties

Article 25 If a registratio n of medical device is obtained in violation of this provision by submitting a false certificate, document or sample or through any other fraudulent means, the original registration agency shall revoke the registration and not accept another registration application of that enterprise in the next two years. A fine will also be levied in accordance with the relevant articles of the Provision on the Supervision and Management of Medical Device.

Article 26 If an enterprise changes the instructions for the use of the product by enlarging product applicable scope or indication for use without authorization, such case shall be handled in accordance with Article 35 of Provision on the Supervision and Management of Medical Device. The violation is considered as manufacturing medical device without registration for manufacturing permit, and the original registration agency shall revoke the product registration.

Article 27 If the applicant has disputes about the conclusion of medical device registration evaluation, the applicant may submit application requesting for documentation re-examination within thirty working days upon receipt of the decision notice. The request shall specify the application number of the original application, the product name and the name of the manufacturer and the reason for the request for application re-examination as well as relevant documents and samples.

Article 28 If it is discovered that the safety or effectiveness of a post-market medical device can not be ensured, drug administration of provincial level or above shall revoke the registration certificate according to the corresponding regulations. Those medical devices, the registration of which have been revoked, must not be manufactured, sold or used. The local drug administration shall be held responsible for the supervision and disposal of the devices already manufactured or used.

Article 29 The State Drug Administration has the right to order a local administration (provincial level or lower) to make corrections within a certain period of time in cases where the state bureau determines that registration is handled in violation of this provision. If such correction is not made within the specified time limit, the state administration may directly announce the revocation of the registration certificate that was illegally registered.

Chapter VI Supplementary Articles

Article 30 The State Drug Administration reserves the right to interpret this provision.

Article 31 This provision goes into effect April 10, 2000 in conjunction with the abolishment of the original Decree No. 16 of the State Drug Administration, Provision on the Medical Device Registration.

Appendix: Sub-provisions on the Clinical Trials Report for the Medical Device Registration

Sub-provisions on the Clinical Trials Report for the Medical Device Registration 

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