Article 1 These Provisions are formulated in accordance with the Regulations for the Supervision and Administration of Medical Devices for the purposes of strengthening the administration of medical devices, enhancing the quality management of medical device manufacturers, and ensuring safety of patients.

Article 2 The Provisions are applicable to the evaluation of enterprises applying for registration for Class II and Class III medical devices, and the regular inspections to medical device manufacturers.

In any of the following cases, enterprises are regarded as passing the quality system assessment:

1. Where enterprises have obtained GB/T19001 and YY/T0287 standard (or GB/T19002 and YY/T0288 standard) quality system certificates issued by the quality certification institutions recognized by the drug regulatory department of the State Council and the certificates are within the period of validity.

2. Where products are subject to industrial goods production licenses, and the licenses are within the period of validity.

3. Where the products are subject to product safety certification and the certificates held by the enterprises are within the period of validity.

Article 3 The application for Class II and Class III medical devices manufacturing quality system assessment shall be accepted by, and the assessment shall be conducted by the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the Central Government, where the enterprises are located.

For some Class III medical devices specified by the government, the local drug regulatory departments of the provinces, autonomous regions and municipalities directly under the Central Government shall accept the applications and then submit them to the State Food and Drug Administration. The State Food and Drug Administration shall organize and conduct the assessments.

The catalogue of specified Class III medical devices is determined and announced by the State Food and Drug Administration.

Quality system assessment can be entrusted to and conducted by the drug regulatory department at the next lower level, or by recognized third-party agencies. The entrusting party shall be responsible for the results of such assessment.

Article 4 Before applying for the product registration, enterprises should fill in the Application Form for Assessment on Medical Device Manufacturing Quality System (see Appendix 1), and submit the applications to drug regulatory departments at provincial level or above.

With regard to some Class III medical devices specified by the State, enterprises shall submit the application form along with the Product Quality Assurance Manual and Process Documents of the relevant product to the State Food and Drug Administration.

For all other products, before applying for quality system assessment, enterprises should conduct self-examination by filling the Self-examination Form for Quality System Assessment (See the table attached to Appendix 1). Information provided in the form should be truthful and accurate for on-site inspection.

Article 5 With regard to Class II medical devices, drug regulatory departments at provincial, autonomous region, and municipal government level shall check the Self-examination Form for Quality System Assessment and relevant materials submitted by enterprises and provide comments after examination. On-site inspections to the enterprises shall be conducted when necessary.

As to Class III medical devices, after complying with Article 3 of the Provisions, original copies of the Application Form for Assessment on Medical Device Manufacturing Quality System and Report on Assessment for Medical Device Manufacturing Quality System (see Appendix 1 and Appendix 2) shall be submitted to the State Food and Drug Administration for the record.

Article 6 There should be at least one auditor trained in implementation of GB/T19001 and YY/T0287 standards and certified as internal or external auditor. The auditor team shall be composed of at least two persons. It shall be ascertained that the auditors are of no economic interests to the enterprises being audited.

Article 7 The on-site quality system assessment shall be referred to examination methods used in quality system certification, and based on the contents of the self-assessment form as Appendix 1. Key assessment items and criteria are specified in the following table:

For an enterprises that passes the assessment, the comments on quality system and the statement of not passed items shall be faithfully made. A timeline for rectification of the not passed items shall be set. Where rectification is not completed within the timeline, the assessment result shall be regarded as “re-assessment after rectification”.

Article 8 Where the assessment result is “re-assessment after rectification”, the enterprise shall complete the required rectification and apply for re-assessment within half a year from the date the assessment report is signed. Otherwise, the enterprise is disqualified for registration application.

Article 9 The product manufacturing quality system assessment has a valid period of four years from the signing date of the “assessment report”. During this term, no further assessment is required for the enterprise applying for registration of a similar products (except specified otherwise by the State Food and Drug Administration).

Enterprises shall conduct regular self-assessment, record and archive the results according to the Self-examination Form for Quality System Assessment.

The drug regulatory departments of a province, autonomous region or municipality directly under the Central Government shall conduct regular system assessment on those enterprises.

Article 10 Where an enterprise, after passing the quality system assessment, fails to carry out self-assessment as required or organize production in accordance with the requirements of quality system, once confirmed, the drug regulatory department of the province, autonomous region or municipality directly under the Central Government, where the enterprise is located, shall issue warnings and require rectification within a specific timeline.

Article 11 The Provisions shall be interpreted by the State Food and Drug Administration.

Article 12 The Provisions shall become effective as of July 1, 2000.

Appendix 1: Application Form for Assessment on Medical Device Manufacturing Quality System

(Attached: Self-examination Form for Quality System Assessment)

Appendix 2: Assessment Report on Medical Device Manufacturing Quality System

[Appendix1]

Application Form for Assessment on Medical Device Manufacturing Quality System

Our enterprise is hereby, in accordance with the provisions concerning medical device registration in the Regulations for the Supervision and Administration of Medical Devices, applying for registration for product. The enterprise has prepared according to the requirements of the Provisions for Medical Device Manufacturing Quality System, and has conducted quality system self-assessment. The enterprise certifies that information filled in the self-assessment form is true and now is applying for quality system assessment.

A Self-examination Form for Quality System Assessment is attached

(Name of Enterprise, Signature of the Legal Representative)

Date: (Enterprise Stamp)

Self-examination Form for Quality System Assessment

1.      General Information of the Enterprise

2. Plan to establish and complete enterprise quality system according to GB/T19000 standard:

1) Is there any plan to establish and improve enterprise quality system according to GB/T19001 (or GB/T19002), and YY/T0287 (or YY/T0288) standards?

Yes □ No □

2) The enterprise plans to apply for quality system certification in year ____ , or it has no such a plan.

3) There are _______employees who have received training on GB/T19000 standard and YY/T0288 standard. There are ______employees who have acquired certificates as internal auditors.

4) Existing difficulties in passing quality system certification:

Expense□ ； No Specialist □； Low-level management □；Lack of awareness/acknowledgement□ ； Less imperative □

3. Name of the product for registration and scope of products covered in this report

Name of Product:_______________________

Scope of products covered in this report: ______________________

4. The enterprise’s quality management responsibilities

1) Are responsibilities of quality management, implementation and verification personnel established and documented?

Yes □ No □

2) The representative of management for the enterprise is _______; or no one is appointed□

3) Is the organizational chart of quality system available? Yes □ No □

4) Does your enterprise collect and keep laws, regulations, administrative rules, and quality standards of various levels related to production and operation?

Yes □ No □

5) Has the legal person or management representative received training in GB/T19000 and YY/T0287 standard? Yes □ No □

5. Design Control

1) Has the enterprise established and maintained a documented procedure or relevant requirements for design control and verification? Yes □ No □

2) Was risk analysis conducted during the design process? Yes □ No □

3) Has the enterprise established and maintained all technical specifications/norms and technical documents to be applied to the product (including a list of the product’s technical documents)? Yes □ No □

4) Is a record on product design modification for registration after trail production maintained? Yes □ No □

6. Purchase Control

1) Has the enterprise established and maintained a documented procedure for the control of purchase process? Yes □ No □

2) Has the enterprise established a purchasing list of major items for the product applying for registration and decided on qualified subcontractors? Yes □ No □

3) Is the purchasing information of the product explicit and complete? Yes □ No □

7. Process Control

1) Has the enterprise defined the critical and special production process of the product for registration and established relevant control documents or working instructions? Yes □ No □

2) Is the production of sterile medical devices organized in accordance with the Production Management Standard for Sterile Medical Devices? Yes □ No □

3) Are the required equipments, overalls and testing instruments for such product provided meeting the requirements for manufacture? Yes □ No □

4) Do the personnel in the manufacture of the product have relevant qualifications or receive specific training? Yes □ No □

5) Has the enterprise established the contents, procedures, and records of the process testing for the product/ testing in production process? Yes □ No □

6) Has the enterprise specified the required working environment and cleanliness of the product? Yes □ No □

7) Has the enterprise established technical materials and acceptance standard for the installation, examination and testing of the product? Yes □ No □

8) Has the enterprise defined the records of process control? Yes □ No □

9) Has the enterprise defined the scope and extent of the product’s traceability (material, component, process, and destination/whereabouts)? Yes □ No □

10) Are the product label (including final product label) and marks of the status of examination and testing visible on production site? Yes □ No □

8. Product Examination and Testing

1) Has the enterprise established professional institutes for examination and testing of product and defined their responsibilities and authorities? For active medical device and implantable medical devices, has the enterprise established identity records of those inspectors? Yes □ No □

2) Has the enterprise established the procedure for examination and testing, as well as documentation? Yes □ No □

3) Does the enterprise conduct examination and check-up on in-coming goods? Yes □ No □

If yes, please list the procedures, and names for such examination and check-up ____________________________________________________

4) Does the enterprise conduct process examination? Yes □ No □

If yes, please list the procedures and names for such examination ____________________________________________________

5) Does examination and testing of the final product cover all the testing items defined in technical standard? Yes □ No □

6) Does the enterprise maintain the record of such final product examination and testing, and report of the latest type testing? Yes □ No □

7) Does the enterprise have relevant testing equipment? Yes □ No □

8) Has the enterprise established and carried out the required documents on the control, calibration, and maintenance for the examination, measuring and testing equipments? Yes □ No □

9. Others

1) Does the enterprise regularly carry out review, evaluation and assessment on product quality and quality management? Yes □ No □

2) Does the enterprise keep the records for the above-mentioned assessment? Yes □ No □

3) Are there any stipulations on assessment and handling of nonconforming products? Yes □ No □

4) Does the enterprise deal with customer complains according to established procedures and keep the records? Are customer complaints handled in accordance with set procedures and records kept? Yes □ No □

5) Are there any stipulations for carrying out corrective and preventive measures? Yes □ No □

10. Conclusions on enterprise’s self-assessment by provincial-level competent authority

Date (Provincial-level Regulator Stamp)

[Appendix 2]

Assessment Report on Medical Device Manufacturing Quality System

1. Members of Assessment Team

2. Main Field Staff Members of the Assessed Enterprise

Name

Position

Department

 Title

3. Date of assessment：__________________

4. Assessment conclusion and suggestion: 

1) General evaluation of the enterprise’s quality system

2) Statement about the unsatisfactory parts

3) Conclusion (“pass” or “re-assessment after rectification”) 

4）Signature of the head of assessment team            

                                            Date         

5. Opinion of enterprise’s legal representative

              Signature of Legal Representative of Enterprise             

Date