The following cases can be regarded as having passed the enterprise quality system assessment:
(a) the State Council drug regulatory authorities recognized by the quality certification body issued by the GB / T19001 and YY / T0287 (or GB / T19002 and YY / T0288) standard quality system certification certificate, the certificate is valid.
(B) has implemented the production license for industrial products, the certificate is valid.
(C) has implemented product safety certification, product safety certification held by the enterprise within the validity of the certificate. Article III application for the second and third class of medical device manufacturers quality system assessment, are the location of the province, autonomous region, municipality 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 enterprises 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 Schedule) for self-examination, fill in the self-examination form. Self-inspection form should be filled out truthfully and accurately for on-site inspection. Article II of 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, the applicant enterprise on-site inspection.
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. Article VI 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 by the composition of the appraisal; identified appraisal of the personnel and the enterprise to be assessed should have no economic interest in contact. Article VII of the quality system on-site assessment, with reference to the quality system certification audit method; based on Annex 1 self-examination form to determine the content of the assessment, the key assessment items and determination of the rules for:
The assessment concluded that "through the assessment", the evaluation of the quality system and the existence of unqualified items should be truthfully stated, the unqualified items Give the deadline for rectification. Those who can't complete the rectification as scheduled shall be treated as "review after rectification". Article 8 If the conclusion of the appraisal is "review after rectification", the enterprise must complete the rectification and apply for review within half a year from the date of signing the "appraisal report", and the qualification of applying for registration of permitted production will be canceled after the expiration of the period. Article IX of 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 for drug supervision and management departments to provide otherwise).
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 and municipalities directly under the Central Drug Administration regularly review the system of enterprises. Article X enterprises through the quality system assessment, not in accordance with the provisions of the self-examination, not in accordance with the quality system requirements of the organization of production, verified by the location of the provincial, autonomous regions, municipalities directly under the Central Drug Administration to 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.