Medical network - February 22 February 21, after prime minister li keqiang endorsement, printed and distributed by the state council "" much starker choices-and graver consequences-in" national drug safety planning "(hereinafter referred to as the" planning ") published the full text.
"Planning" in 2016-2020 listed medical equipment inspection tasks include:
1, every year to all national third class medical device manufacturing enterprise and the second category of sterile medical device manufacturing enterprise for a whole project inspection. Since 2018, every two years for the rest of the second category of medical device manufacturing enterprise and all the first kind of medical device manufacturing enterprise for a whole project inspection. Every year about 30-40 overseas medical device manufacturing enterprise quality management system to carry out the inspection, during the period of "much starker choices-and graver consequences-in" realizing a complete coverage of the high-risk medical equipment products to be imported.
2, every year for the whole check have special request for storage and transportation enterprise, "much starker choices-and graver consequences-in" during implementation of sterile, implantable medical devices and in vitro diagnostic reagents enterprise full coverage checking.
3, each year for the whole check third rate medical equipment usage of medical institutions, "much starker choices-and graver consequences-in" during the implementation of a complete coverage of other units to use check.
In the next few years, sterile, implantable medical devices and class iii medical devices are the focus of the agency inspector. And blue instruments that parker, the 2017 this type of medical devices nationwide examination has launched last month, and check covers production, management and use of the whole process.
Learned, on January 17, 2017, general office of national drug safety administration issued "about strengthening asepsis and implantable medical devices such as the supervision and inspection of the notice" (hereinafter referred to as the "notice").
Around the "notice" requirements, formulate practical work plan, the area under its jurisdiction aseptic production and management enterprises and implantable medical devices and use the unit to carry out supervision and inspection.
Scope of inspection: the provinces disposable sterile, implantable medical devices, and in addition to the sterile, third class medical planted instruments production enterprises; The provincial part sterile and implantable medical devices management enterprise; The provinces all secondary and tertiary hospitals.
Notice in accordance with the schedule, at least 1918 aseptic production enterprises, 339 into production enterprises, 1089 other third class medical equipment manufacturing enterprises, as well as 33896 business enterprises, 1954 1954 tertiary hospitals, secondary hospitals will accept the supervision and inspection in years.
Among them, sterile, implantable devices for specific check varieties directory as follows:
Administration of drug safety for the provinces designated inspection and summary report deadline is December 10, 2017. For the problems found in the supervision and inspection, production and operation enterprises and the use of units required to make correction, and by the number of the agency shall, in accordance with the supervision and inspection by more than 20% of the proportion of review.
The following key inspection of for different enterprises:
For sterile and implantable medical device manufacturing enterprise, focusing on:
1, procurement procedures is in line with the requirements, whether the supplier audit evaluation. Enterprises may not purchase under laws, regulations and national compulsory standards requirements of the product, and shall have the corresponding inspection and verification records;
2, control is in line with the requirements of clean room (area);
3, the sterilization process is in line with the requirements, especially the product aseptic performance and ethylene oxide residues should meet the standard requirements, and there are inspection records;
4, whether the production process of special process and key process for the identification and control;
5, the product traceability is in line with the requirements;
6, medical device adverse event collection and product recalls.
Other third class medical device manufacturing enterprise focusing on:
1, improve the quality management system;
2, the enterprise is equipped with matching to the products and production scale of production and processing equipment, and effective operation.
3, whether enterprises set up a supplier audit system;
4, whether product traceability;
5, whether to establish and implement quality control program;
6, adverse event monitoring and product recalls.
Business areas:
1, marketing channel is legal;
2, incoming inspection records in the record and sales matters is true complete;
3, whether the business registration certificate, qualification certificate, expired, invalid or obsolete YiXie products;
4, transport and storage conditions is in line with the label and manual identification requirements;
5, whether with the products that meet the needs of technical training and after-sales service capacity.
Using the link:
Corresponding to the scale of 1, is equipped with YiXie quality control organization or personnel;
2, whether to establish the use of covering the whole process of quality management system;
3, whether by the regulation of medical equipment procurement unified management;
4, whether strictly examine the supplier qualification and product documents;
5, whether to keep the relevant records and information;
6, in sterile and implanted medical equipment is set up and implement the system of quality inspection before use;
7, whether to implant and involved in class equipment set up using records, using the record is saved, relevant information is included in the information management system, ensure traceability with relevant information, etc. |
