According to public data from the State Food and Drug Administration (SFDA), as of the end of November 2016, there were actually 4,979 enterprises that could produce class I medical device products and 8,957 enterprises that could produce class II medical device products in the country.
Also from the General Administration of Pharmaceutical Supervision information, following the third category of mechanical enterprises first landing medical device GMP will be, since 2018, all the first and second category of mechanical enterprises must also comply with the requirements of medical device GMP.
2018 is the key year for the first and second category of mechanical enterprises to meet the medical device GMP standard, and will also be the key year for them to receive strict supervision. The General Administration of Pharmaceutical Supervision (GAPS) has long issued a notice to conduct double random public sampling inspections of more than 50 percent of the first and second category of mechanical enterprises, and to launch flight inspections of these two categories of mechanical enterprises in due course.
Nearly 5,000 first-class mechanical enterprises across the country will usher in a storm of inspections by the Drug Administration within this year. So, for the first class of medical equipment manufacturers, drug supervision mainly check what?
Class I medical device manufacturers, due to their products have a higher safety, lower risk of the basic characteristics, in the regulatory process is easy to be ignored.
However, due to the lack of attention earlier, the number of reported cases involving Class I medical device products has been increasing year by year. This is due to the two or three types of enterprises to start and product registration are subject to on-site inspection and system assessment, quality management has a corresponding foundation, and therefore relatively small problem. The production of a class of medical devices alone, but there are some common problems, such as: the lack of management system, quality management system can not cover the production, inspection of the whole process, and the enterprise's production, inspection records filled out there are incomplete, non-standardized, and not in accordance with the provisions of the plant, warehouse, equipment to implement the overall management. Factory inspection equipment is not measured, the staff of the serious lack of awareness of regulations, personnel management and other loose problems prevail.
In order to be able to better solve the quality management problems in the production process of medical devices, according to the requirements of the Circular of the State Food and Drug Administration on the Implementation of the Quality Management Standards for the Manufacture of Medical Devices on Related Matters (No. 15 of 2014), by January 1, 2018, all medical device and in vitro diagnostic reagent manufacturers are required to implement the GMP management system.
The following are the key items in the key points of on-site inspection of Class I medical device manufacturers:
Institutions and personnel
1. The responsibilities and authorities of each department should be clearly defined, and the quality management function should be clarified.
2. The person in charge of the enterprise should ensure that the enterprise organizes production in accordance with the requirements of laws, rules and regulations.
3. Should have the appropriate quality inspection organization or full-time inspectors.
4. Personnel engaged in work affecting product quality should be trained to meet the requirements of their positions, with relevant theoretical knowledge and practical skills.
Plant and facilities
1. Plant and facilities should be based on the characteristics of the products produced, the process and the corresponding clean level requirements for rational design, layout and use.
2. Should be equipped with products and production scale, variety, inspection requirements to adapt to the inspection sites and facilities.
Equipment
1. Should be equipped with products and scale of production to match the production equipment, process equipment, should ensure effective operation.
2. Should establish the use of testing instruments and equipment records, records should include the use, calibration, maintenance and repair.
Document management
1. Should establish and improve the quality management system documents, including the quality policy and quality objectives, quality manual, procedural documents, technical documents and records, as well as other documents required by law.
2. Technical documents should include product technical requirements and related standards, production process procedures, operating instructions, inspection and testing procedures, installation and service procedures and other related documents.
Design and development
1. Design and development output should meet the input requirements, including procurement, production and service related information needed, product technical requirements.
2. Elected materials, parts or changes in product features may affect the safety and effectiveness of medical device products, should evaluate the risks that may be brought about by the changes, and if necessary, take measures to reduce the risk to an acceptable level, and at the same time should be consistent with the relevant regulatory requirements.
Procurement
1. Procurement control procedures should be established.
2. It shall be ensured that the purchased items meet the stipulated requirements and are not lower than the relevant provisions of laws and regulations and the relevant requirements of national mandatory standards.
3. Should sign a quality agreement with the main raw material suppliers to clarify the quality of the responsibility borne by both parties.
4. Purchasing records should meet the requirements of traceability.
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Production management
1. Production should be carried out in accordance with the establishment of a quality management system to ensure that the product complies with the mandatory standards and registered or filed product technical requirements.
2. Production process regulations, operating instructions, etc. should be prepared to clarify the key processes and special processes. Check the relevant documents; whether to specify the key processes and special processes, key processes and special processes of the important parameters whether to do verification or confirmation of the provisions.
3. Each batch (unit) of products should have production records, and to meet the requirements of traceability.
4. Should be in the production process to identify the product inspection status, to prevent the flow of unqualified intermediate products to the next process.
5. Should establish product traceability program, the scope of product traceability, the degree of identification and the necessary records.
6. Product instructions, labeling should be consistent with relevant laws and regulations and standards.
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Quality control
1. Should be based on mandatory standards and registered or filed by the technical requirements of the product to develop the product inspection procedures, and issue the appropriate inspection report or certificate.
2. Each batch (table) of products should be a batch of inspection records, and to meet the traceability requirements.
3. Should provide product release procedures, conditions and release approval requirements.
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Sales and after-sales service
Should establish product sales records, and to meet the traceability requirements.
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Control of nonconforming products
The nonconforming products should be labeled, recorded, segregated, and evaluated, and according to the results of the evaluation, corresponding disposal measures should be taken for the nonconforming products.
Adverse events
1. should be established in accordance with relevant regulations and requirements of the medical device adverse event monitoring system, to carry out monitoring and re-evaluation of adverse events, and maintain relevant records.
2. The existence of potential safety hazards of medical devices, should be in accordance with relevant laws and regulations require the adoption of measures such as recall, and in accordance with the provisions of the report to the relevant departments.
3. Should carry out regular management review, evaluation and audit of the quality management system to ensure its continued suitability, adequacy and effectiveness.