All provinces, autonomous regions and municipalities directly under the food and drug administration, food and drug administration of Xinjiang:
For strengthening medical devices production supervision management, guide regulatory sector on medical devices production enterprise implementation medical devices production quality management specification and related Appendix of site check and on check results of assessment, according to medical devices production quality management specification and related Appendix, national food drug supervision management general organization developed has medical devices production quality management specification site check Guide principles medical devices production quality management specification no bacteria medical devices site check Guide principles Medical device manufacturing practices of implantable medical device inspection guidelines medical device manufacturing practices in vitro diagnostic reagents for on-site inspection guidelines. It is issued to you, please follow.
Guiding principles to guide regulators on medical device manufacturers to implement the medical device manufacturing practices and related site inspection and assessment of the results of the Appendix, applied to medical device registration on-site verification, medical device manufacturing license (including extended or changed) on-site inspections, as well as in accordance with the needs for medical device manufacturing enterprises to carry out supervision and inspection.
In the on-site verification of registration, licensing of medical devices (including change) on-site inspection, the inspection team shall, in accordance with guidelines issued by the CBRC on-site examinations proposed conclusions, suggestions and conclusions into "by checking the" "did not pass the check" "after rectification reviewed" three scenarios. On-site inspections are not found in the enterprise does not meet the project's, suggestions and conclusions for "check". Spot checks found in business-critical projects (ID "*") does not meet the requirements, or just have a General (not identified "*") does not meet the requirements, but it may have a direct impact on product quality, recommends that the conclusions as "did not pass the check." Present only in General does not meet the requirements of the project, and have a direct impact on the quality of the product, suggestions and conclusions "after rectification reviewed". Check conclusion for "rectification Hou review" of enterprise should in site check end Hou of provides time within [which registered verification in 6 months within, production license (containing change) site check in 30 days within] completed rectification and to original review sector one-time submitted rectification report, review sector necessary Shi can arrangements for site review, all project meet requirements of, recommends conclusion for "through check". Failure to submit within the prescribed corrective action report or review are still does not meet the project's proposed conclusions for "did not pass the check." Production license continue spot checks found that enterprises do not meet project, rectification shall notify the enterprise, still does not meet the requirements after rectification shall not be extended.
In all kinds of supervision and inspection, find key does not meet the requirements of the project, or just generally does not meet the requirements of the project, but may have a direct impact on product quality should be required enterprises to stop production improvement; only found general projects do not meet the requirements, and have a direct impact on the quality of the product, companies should be required rectification.
Regulators should be submitted by the Inspection Unit recommendations conclusion information and on-site inspections of audit, issued the final results.
About breaches of the regulations on supervision and administration of medical devices, and related laws and regulations, it shall be handled according to the rules.
The food and drug administration
9/25/2015