Article I In order to strengthen the management of medical devices, strengthen the quality control of enterprises, to ensure the personal safety of patients, according to the "supervision and management of medical devices regulations", the development of these measures.
Article 2 These measures apply to the application of Class II, Class III medical device quasi-registered enterprises and the review of the enterprise's periodic review.
The following cases can be regarded as having passed the enterprise quality system assessment:
(a) the enterprise to obtain the State Council drug regulatory authorities recognized by the quality certification body issued by the GB/T19001 and
YYY/T0287 (or GB/T19002 and YY/T0288) standards of quality system certification certificate, the certificate is valid.
(B) has been implemented in the production of industrial products license products, the certificate within the validity period.
(C) has implemented product safety certification, product safety certification held by the enterprise within the validity of the certificate.
The third application for the second, three types of medical devices manufacturer quality system assessment, are located in the provinces, autonomous regions and municipalities directly under the Central Drug Administration to accept and organize the assessment.
State part of the three types of medical devices, by the local provinces, autonomous regions and municipalities directly under the Central Drug Administration acceptance, reported to the State Drug Administration, the State Drug Administration to organize the assessment.
Part of the catalog of Class III medical devices by the State Drug Administration to determine and publish.
Quality system assessment, can be entrusted to the next level of drug supervision and management departments or third-party organizations with appropriate qualifications. Quality system assessment results by the commissioning party.
Article IV of the enterprise in the application for product registration, should fill out the "medical device manufacturer quality system assessment application" (see Annex 1), to the provincial level above the drug supervision and management department to put forward the enterprise quality system assessment application.
State part of the three types of medical devices quality system assessment, the enterprise quality system assessment application at the same time, to the State Drug Administration to submit to the assessment of the product's "quality assurance manual" and "procedural documents.
Other products of the quality system assessment, the enterprise quality system assessment application, should be made according to the "quality system assessment of the enterprise self-examination form" (see Annex 1 of the attached table) for self-examination, fill in the self-examination form. Self-inspection form should be filled out truthfully and accurately, in order to prepare for the on-site assessment when checking.
Article V of Class II medical devices, provinces, autonomous regions, municipalities directly under the Central Drug Administration should fill out the "quality system assessment of enterprise self-examination form" and provide relevant information for review, after review and sign the opinion, if necessary, on-site inspection of the applicant company.
Three types of medical devices, according to the implementation of Article III of these measures, the quality system assessment application and assessment report (see Annex 1, 2) should be filed in the State Drug Administration of the original (original) one.
Sixth appraisal should be at least one person by the implementation of GB/T19001 and YY/T0287 standard training, and obtain the qualification of internal or external auditor; appraisal of at least two people; identified appraisal of the personnel and the enterprise to be assessed should have no economic interest in contact.
Article 7 The quality system on-site examination shall refer to the method of quality system certification audit; the examination shall be carried out based on the contents determined in the self-examination table in Annex 1, and the key examination items and determination rules shall be as follows:
┌────┬──────────┬───────────────┐
││Product category│ Key examination items │ Appraisal conclusion │< /p>
│ │ IV.1, 2 │ 1. All the key examination items are qualified, and the other │
│ ├──────────┤ appraisal items do not conform to more than five items, │
│ │ III │ V.1, 3 │ Judgement of passing the appraisal. │
│ ├￥──────────┤ 2. There are failures in key assessment items, and other │
│ │ │ VI .1, 2, 3 │ The non-conformities of the assessment items are more than five items, │
│ ├￥──────────┤ Judged to be corrected and then re-examined. │
│ │ VII.1,2,3,9,10 │ │
│ ├──────────┤ │
│ │ Class │ VIII.1,2,6,7,8 │ │
│ ├──────────┤ │
│ │ IX.2,3,4,5 │ │
│ │ IV.1 │1.Focused assessment items All pass, other │
│ ├──────────┤ appraisal items do not meet more than five items, │
│ │ II │ V.1.3 │ │ Judged as passing the examination. │
│ │ VI.1 │ If there are more than five non-conformities in the appraisal items, │
│ ├──────────┤ the judgment is to review the appraisal after rectification. │
│ │ VII.1, 2 │ │
│ ├──────────┤ │
│ Class │ VIII.1, 6, 8 │ │
│ ├──────────┤ │
│ │ IX.2, 3, 4 │ │
└────┴──────────┴────────── ─────┘
The conclusion of the examination is judged as "passing the examination", the evaluation of the quality system and the existence of unqualified items should be truthfully stated, and the unqualified items are given a period of rectification. Can not be completed as scheduled rectification should be treated as "rectification review".
Article VIII of the appraisal conclusion of "rectification and review" to "assessment report" from the date of signing, the enterprise must be completed within six months to rectify and apply for a review, the late application will be canceled to apply for registration of permitted production qualifications.
Article IX of the enterprise product quality system assessment to "assessment report" through the signing of the date shall prevail, and its validity for four years; in the validity of the enterprise to apply for registration of similar products quasi-production, and no longer assessed (except as otherwise provided by the drug supervision and management departments).
Enterprises should be regularly quality system self-examination, self-examination results should be in accordance with the provisions of the "quality system assessment of enterprise self-examination form" records, archives.
Provinces, autonomous regions, municipalities directly under the Central Drug Administration regularly review the system of enterprises.
Article X of the enterprise through the quality system assessment, not in accordance with the provisions of the self-examination, not according to the quality system requirements for the organization of production, verified, by the location of the provinces, autonomous regions and municipalities directly under the Central Drug Administration shall be warned, and a deadline for rectification.
Article XI of these measures by the State Drug Administration is responsible for the interpretation.
Article XII of these measures since July 1, 2000 shall come into force. (Annex 1) "medical device manufacturers quality system assessment application"
(Attachment) "quality system assessment of the enterprise self-examination form"
(Annex 2) "medical device manufacturers Quality System Assessment Report"