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Laws & Regulations - Medical Devices - Provisions for Assessment on Medical Device Manufacturing Quality System
Provisions for Assessment on Medical Device Manufacturing Quality System
 
2012/3/20 14:42:59¡¡Source: ¡¡Hits:

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:

Classification of  Products

Key Assessment Items

Assessment Results

Class III

IV. 1, 2

1. Key assessment items all passed  and five other items at most not passed. Result: pass

2. Key assessment items not all passed and more than five other items not passed.

Result: Re-assessment after rectification

V. 1, 3

VI. 1, 2, 3

VII. 1, 2, 3, 4,9, 10

VIII. 1, 2, 6, 7, 8

IX. 2, 3, 4, 5

Class II

IV. 1

1. Key assessment items all passed and five other items at most not passed. Result: pass

2. Key assessment items not all passed and more than five other items not passed.

Result: Re-assessment after rectification

 

V. 1, 3

VI. 1

VII. 1, 2

VIII. 1, 6, 8

IX. 2, 3, 4

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 rectificati

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