On April 16th and April 12th, the Heilongjiang Provincial Food and Drug Administration printed and issued the “Major Points for Medical Device Supervision in the Province of 2018” and the “Supervision and Inspection Plan for Medical Device Manufacturing Enterprises in Heilongjiang Province in 2018.” Check the key points, and will publish the work plan, organize and launch the special rectification of cracking unlicensed medical equipment and the use of unlicensed medical devices, and 'offline' remediation and 'on-line' remediation will be promoted simultaneously.
Within two days, two documents were issued, tightening the high-pressure situation of non-compliant companies and clarifying the three major inspection priorities.
(1) Products are listed in the national and provincial-level manufacturers of key medical device catalogs.
(II) Poor quality management system operation, last year product quality Supervised sampling inspections, complaints and reports, there is a large product quality and safety risks of the enterprise.
(iii) Sterile and implantable medical devices, third-type medical devices, imaging diagnostic equipment, electrotherapy equipment, denture metal materials and denture ceramic materials manufacturing enterprises.
According to the regulatory requirements, the first type and second type medical device manufacturing enterprises in the jurisdiction shall be selected in accordance with the principle of 'double randomness and publicity' for no less than 50% of the entire year; The production company implements full coverage of the entire project inspection.
At the same time, the inspection plan also put forward job requirements, focusing on 'problems', problem-oriented, and continued to increase inspections of production companies for flight inspections. Shun Manpagua is generally unsatisfactory for spot inspections, complaints and reports on products, targeted Conduct flight inspections to maintain a high pressure on non-compliant companies. Efficient and effective.
The specific inspection contents of the three major inspections are as follows:
(a) For aseptic, implantable, in vitro diagnostic reagents medical instruments produce enterprise , Mainly inspect whether its quality system maintains effective operation. The focus is on the control of the clean room (area), sterilization process control, process water use gas control, product traceability, product testing (especially sterility inspection) meets the requirements Wait.
(2) For custom denture manufacturing enterprises, it is mainly checked whether they meet the requirements of the specification and the customized denture appendix. On January 1, 2018, custom denture manufacturers must implement the specification and custom denture appendix. In custom dentures Appendices for institutions and personnel of custom denture manufacturing companies, plant and facilities, equipment, purchase , Production management, quality control, nonconforming product control, sales and after-sales service, etc. have made more specific, specific, strict special requirements.
(3) The municipal (prefecture) bureaus must strengthen the supervision of all enterprises in the jurisdiction, and enterprises must establish a quality management system that meets the requirements of the regulations and ensure their effective operation. Examine the quality control points of the production process and ensure the approval of registration with the product. The technical requirements are consistent, product release must comply with the release procedures to meet the release conditions and inspection procedures; strict inspection of raw material procurement and quality control, the main raw materials must meet the quality of raw materials provided by the registration of products standard , Never allow untested and unqualified raw materials to be put into use.
In addition to carrying out special operations to crack down on unlicensed operations, the Heilongjiang Provincial Bureau will also organize special inspections for the addition of fluorescent whitening substances to disposable infusion instruments. Manufacturers of disposable infusion instruments will undergo self-inspection, supervision and inspection, and severe punishment. Other aspects such as full deployment.
