State Drug Administration Order

  Number 22

    This Medical Device Manufacturing Enterprise Quality Inspection System Method was created and passed by the State Drug Administration at the general affairs meeting on April 29, 2000. It is henceforth passed and shall come into force effect from July 1, 2000.

Director General: Zheng Xiaoyu

May 22, 2000

Medical Device Manufacturing Enterprise

Quality System Inspection Method

Article 1 These Regulations are hereby formulated with a view to strengthening enterprise quality control and administration of Medical Device, ensuring patient safety, and enforcing the Regulations for the Supervision and Administration of Medical Device.

Article 2 This method is applicable for the inspection of enterprises that apply for Class II and Class III Medical Device manufacturing registration and respective enterprises’ regular inspections.

Enterprises meeting the following conditions are considered as having already passed the enterprise quality system inspection:
    1. Enterprise obtains the quality system certificate GB/ T19001 and YY/T0287 (or GB/T19002 and YY/T0288) issued by a quality inspection institution authorized by the State Drug Administration, and the certificate is still in its period of validity.
    2. Products with an industrial product manufacturing permission license are still in the period of validity.
    3. Product safety standards are implemented, and corresponding product safety certificates held by the enterprise are still in their period of validity.

Article 3 The inspection of system quality for enterprises applying for production of Class II or Class III Medical Device shall be collected, organized, and inspected by the respective Drug Administration Department of the province, autonomous region, or municipality directly under the central government in which the enterprise is located.

Certain Class III equipment specified by the government should be forwarded to, organized and examined by, the State Drug Administration after collection by the respective Drug Administration Department of the province, autonomous region, or municipality directly under the central government in which the enterprise is located.

The list of specified Class III Medical Device shall be confirmed and distributed by the State Drug Administration. The quality system examination may be entrusted to the next lower-rank Drug Administration department or a third party institution of the same qualification. The entrusted party is responsible for the system quality examination result.

Article 4 Enterprises shall fill out a Medical Device Manufacturing Enterprise Quality Inspection Form (see Appendix 1) before applying for the Product Manufacturing Permission Certificate, and submit the Enterprise Quality Examination System application to the Drug Administration department at or above the provincial level.

For the quality examination application of specified Class III Medical Device, enterprises shall additionally submit to the State Drug Administration a Quality Assurance Manual and a Procedure Form for each product applying for examination.

Before submitting the quality examination system application for all other products, enterprises shall fill in the Enterprise Quality Examination System Self- Inspection Form (see annex form of Appendix 1) and perform self-inspection accordingly. The content of the self-inspection form should be authentic and accurate for the time the inspection is performed.

Article 5 For Class II Medical Device, the respective drug administration departments of the province, autonomous region, and municipality directly under the central government shall check the Enterprise Quality Examination System Self-Inspection Form and any relative materials submitted by the enterprise and note decision; when necessary the relative drug administration department shall perform an on-site inspection to check validity of submitted materials.

For Class III Medical Device, following execution of Article 3 of this method, one original copy of both the Quality Examination System Application Form and the examination report (see Appendix 1 and 2) should be filed and recorded with the Stage Drug Administration for reference.

Article 6 At least one quality inspector shall be trained on examination implementation according to GB/T19001 and YY/T0287 standards and hold a certificate of inner inspector or outer inspector; the inspection group shall be comprised of at least two persons; the appointed inspector shall have no economic relation to the enterprise being examined.

Article 7 The on-site quality examination shall be based on the system of inspection and certification; the inspection should be carried out in accordance with the contents of Appendix 1 self-inspection chart, the focus of the assessment shall be based of the following determining criterion:

Enterprises receiving a “passing” assessment result shall make an authentic statement of the appraisal of the quality system and the existing “failed” items, and shall denote the adjustment deadline of the “failed” items. Those enterprises that do not complete the adjustment before the said deadline shall be dealt with as “re-examine following adjustment”.

Article 8 Enterprises considered “re-examining following adjustment” shall complete the adjustment within six months and apply for re-examination since the signed date of the “examination report”, otherwise the manufacturer registration application qualification will be cancelled.

Article 9 The validity of examination for the enterprise product quality system is four years from signed date of the passed “examination report”; during the validity period, enterprises applying for the manufacture permission registration for the same class product will not be examined again (excluding regulations otherwise specified by Drug Administration departments).

Enterprises should carry out the quality examination system at regular intervals and the assessment result should be recorded and kept on file according to the regulations of the Enterprise Quality Examination System Self-Inspection. The respective drug administration departments of each province, autonomous region, and municipality directly under the central government shall perform scheduled examinations of enterprises.

Article 10 Enterprises which do not perform scheduled self-inspections and do not manufacture according to the quality system requirements after passing the quality examination, will be issued a corrective warning by the drug administration department of the respective province, autonomous region, and municipality directly under the central government and given a time limit to make corrective adjustments.

Article 11 The State Drug Administration shall be responsible for further clarification of any part of this method.

Article 12 This method shall come into force beginning April 20, 2000.

(Appendix 1) Medical Device Manufacturing Enterprise Quality Examination System Application Form

(Annex) Enterprise Quality Examination System Self-Inspection Form(Appendix 2) Medical Device Manufacturing Enterprise Quality Examination System Report

[Appendix 1]

Medical Device Manufacturing Enterprise Quality Examination System Application Form

This enterprise, on the basis of the requirements of the Medical Device Supervision and Administration Conditions intends to conduct registration for the manufacturing of______________ product. It has completed preparations based on Medical Device Manufacturing Enterprise Quality System Examination Methods and completed the quality self-inspection and assures the authenticity of content contained in the form, and hereby applies for quality examination.

Enclosed, one Enterprise Quality Examination System Self-Inspection Form.

Name of the Enterprise, Signature of Legal Representative

______________. _______________. Year Month Day (Enterprise Seal)

Enterprise Quality Examination System Self-Inspection Form

I. Basic Information of the Enterprise

II. Establish a complete enterprise quality system plan according to the GB/T19000 series standard.
     1. Has the enterprise prepare for constructing a complete quality system based on the GB/T19001 (or GB/T19002), and YY/T0287 (or YY/T0288) series standards?

Yes No
     2. The enterprise plans to apply for quality system certificate in year ______. There is yet no plan?
     3. There are _____persons who have been trained on GB/T19000 and YY/T0288 series standards. There are ____ persons who have earned the internal examiner certificate.
     4. The challenge(s) of passing the quality system inspection and certification for the enterprise are the following:

Expense ; Lacking Guidance ; Low Management Level

Lack of Familiarity ; Lacking Sense of Urgency
III. The Product Names and Scope of this Application.

Names of products for certificate registration _____________________.

Scope of products and product names covered by the report: _____________________________.
IV. Enterprise Quality Management Responsibility.
     1. Have the administrative, executive, and inspection working staff taken on quality responsibilities and formulated them as written documents? Yes No
     2. The administrative representative of the enterprise is __________. Has not been appointed
     3. Can the organization chart of the enterprise quality system be provided or not? Yes No
     4. Does the enterprise collect and maintain the laws, statutes, administration regulations and quality standards of various levels related to production and business operation? Yes No
     5. Have the enterprise legal representative(s) or administrative representative(s) been trained on the GB/T19000 and YY/T0287 series standards? Yes No

V. Design Control
     1. Has the enterprise established and maintained the design control, verification or necessary corresponding procedures in written form?  Yes No
     2. Has a risk analysis been carried out during the design and setup process?  Yes No
     3. Have the complete technology regulation and application technology documents for products been established and preserved? (Including the product technology documents list)  Yes No
     4. Has a record of product design adjustment following test production registration been kept?  Yes No

VI. Purchase Control
     1. Has purchase control procedure been established and maintained in written form?  Yes No
     2. Has the main purchase list of the products applying for manufacture permission been established and have the qualified contract groups been defined?  Yes No
     3. Are the purchase materials of the product clear, definite, and complete?  Yes No

VII. Procedure control

     1) Have both the key and special procedures for applying for product manufacture permission registration been confirmed and have the corresponding control documents and manuals been compiled?

Yes No

      2) Have sterile medical devices been produced according to the Sterile Medical Device Production Management Regulations?  Yes No

     3) Are the equipment, installation, and inspection instruments complete? Can they satisfy the requirements of the product manufacturing process?   Yes No
     4). Personnel involved in product construction and production possess corresponding qualifications or relevant training.    Yes No

     5). Has the content, regulations, and records of product examination procedures been confirmed?

Yes No

     6) Have the product working environment and product sanitary requirements been regulated?   Yes No

     7) Have the technological materials and acceptance criteria for product installation and inspection been established?  Yes No

     8) Has the method for recording for procedure control been stipulated?  Yes No

     9) Have the tracing ability range, and degree of the product been confirmed? (Including materials, components, procedures, and destination)   Yes No

     10) Can the product labels (including the final product labels) and the labels of inspection and test condition be seen on site?  Yes No

VIII. Product Inspection and Testing
     1. Have the professional inspection and test institution been established and corresponding responsibilities and authority limits been defined? Have the identification of inspection personnel for radiant medical devices and the implant-able medical devices been recorded?   Yes No
     2. Have the inspection and testing programs been established in written form?   Yes No
     3. Have the inspection and verification of incoming stock been implemented?   Yes No

The regulations for inspection and testing of incoming stock and the corresponding names are

__________________________________________________________________

___________.
     4. Has the procedure inspection been carried out? Yes No

The regulations and names of procedure inspection are

________________________________________________________________

_____________.
     5. Does the final product test inspection cover items for inspection of out-of-factory technological standards?   Yes No
     6. Have the test inspection reports of above test and recent sample records been kept?   Yes No
     7. Does the enterprise possess the corresponding testing equipment?  Yes No
     8. Has the enterprise established and implemented written control, calibration, and maintenance regulations for inspection, measurement and testing equipment?    Yes No

IV. Other Aspects
1. Has the enterprise regularly carried out the auditing, evaluation, and appraisal of product quality and quality management?   Yes No

2) Has the record of last appraisal been kept on file?   Yes No
3. Has the appraisal and handling of unqualified products been stipulated?  Yes No
4. Have customer complaints been handled and recorded according to a definite procedure?  Yes No
5. Does the enterprise possess written procedures for correction and prevention methods?   Yes No

X. Provincial administration department’s decision on enterprise self-inspection results:

Year Month Day (Departmental Director’s Seal)

[Appendix 2]

Medical Device Manufacturing Enterprise Quality Examination System Report

I. Inspection Group Members

II. Members of Inspected Unit Present

III. Inspection date: _____________

IV. Inspection results and suggestions:
     1. Basic appraisal of enterprise’s quality system.
     2. Statement regarding unsatisfactory sections.
     3. Inspection result (suggest pass examination, or suggest re-examination following adjustment and correction).
     4. Head Inspector signature ____________ Date____________

V. Enterprise Legal Representative’s Remarks

Signature of Enterprise Legal Representative_______________ Date

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