Annual validation of the scope of work, time, procedures in accordance with the "Guangxi Zhuang Autonomous Region Medical Device Manufacturing (Management) Enterprise License Annual Validation (Interim) Measures" issued by the Gui Drug Supervision and Inspection issued [2002] No. 19.
Two, the annual validation review requirements
The second, the annual validation of the third class of medical device manufacturers in accordance with the "supervision and management of medical device manufacturers", "medical device manufacturers quality system assessment methods", "single-use sterile medical device products (injection, infusion apparatus) production rules (revised in 2001)" and "Guangxi Zhuang Autonomous Region Medical Devices Implementation Rules for the Recognition of Qualifications of Manufacturing Enterprises".
The second and third class of medical equipment business enterprises annual verification in accordance with the "supervision and management of medical equipment business enterprises", "Guangxi Zhuang Autonomous Region Medical Equipment Business Enterprise Qualification Recognition Implementation Rules" and "one-time use of sterile medical equipment business enterprise qualification recognition implementation rules".
Three, preliminary examination, on-site review
1, division of labor
(1) the annual validation of single-use sterile medical device manufacturers on-site review by the Bureau is responsible for the municipal (local) Bureau of Pharmaceutical Supervision to sign the preliminary examination opinion.
(2) other second and third class medical device production, business enterprises annual validation of the initial and on-site review entrusted to the city (prefecture) Drug Administration is responsible for.
2, the content of the initial and on-site review of production enterprises
The production of single-use sterile medical devices, in accordance with the "single-use sterile medical device products (injection, infusion apparatus) production rules (revised in 2001)" for the initial and on-site review.
Other second and third class medical device manufacturers, in accordance with the "medical device manufacturer quality system assessment methods" and "Guangxi Zhuang Autonomous Region Medical Device Manufacturer Qualification Accreditation Implementation Rules" for quality system assessment and on-site review and preliminary examination. Among them, since 2000 has passed the autonomous region Drug Administration organization of the quality system assessment or quality system certification certificate of the enterprise (except for enterprises that have been relocated or reorganized), no longer for quality system assessment, but should be submitted through the assessment of the material or a copy of the certificate of accreditation.
3, the business enterprise initial and on-site review of the content
The initial and on-site review of one-time use of sterile medical equipment business enterprises, in accordance with the "one-time use of sterile medical equipment business enterprise qualification recognition of the implementation rules". Among them, after May 31, 2002 has been reviewed in accordance with these Implementing Rules qualified non-new enterprises will no longer be on-site review, should be submitted to the original has passed the on-site review of the scoring method (item-by-item review), review of the scoring table and review report (original).
The other second and third types of business enterprises of the initial and on-site review, in accordance with the "Guangxi Zhuang Autonomous Region Medical Device Business Enterprise Qualification Recognition Implementation Rules". Among them, after May 31, 2002 has been in accordance with these Implementing Rules for on-site review of non-new enterprises, no longer on-site review, should be submitted to the original has passed the review of the on-site review of the score sheet (original).
Four, validation
Third class of medical devices with the scope of production of production enterprises and business license is not marked "retail" and contains a one-time use of sterile medical devices business scope of enterprises, by the city (prefecture) Drug Administration after passing the preliminary examination, sent to the autonomous region and Drug Administration validation and verification, stamped with 01 validation special And validation, stamped with a special seal 01 validation.
Other types of production and operation of enterprises by the commissioned city (prefecture) Drug Administration is responsible for validation and verification, qualified to cover the corresponding number of validation seal.
V. Notes
1, for a review of unqualified companies are allowed to rectify and re-examine within two months.
2, the review should be strictly in accordance with the review approach (standards or rules), the enterprise must meet the requirements of the necessary conditions, the veto items must be qualified.
3, the city (prefecture) due to objective reasons and did not complete the 2001 annual validation, can be carried out at the same time in 2001, 2002 annual validation. Each year's validation of the declaration materials should be filled out according to the actual year, while accepting and reviewing. On-site review of the materials attached to the validation application form. Validation of qualified in 2001 and 2002, respectively, the annual validation column signed on the 2001 or 2002 annual validation of the views of the qualified and stamped validation of the special seal.