5000 home appliance enterprises will check the storm this year, check the list of points
According to the open data of the State Drug Administration, as of the end of November 2016, there are 4,979 enterprises producing Class I medical equipment in the country and 8,957 enterprises producing Class II medical equipment.
Also from the information of the General Administration of Supply and Demand of the PRC, after the third type of enterprises have taken the first place to hold the GMP, all the first and second types of enterprises must comply with the GMP requirements of medical equipment since 2018.
2018 is the first and second year of key enterprises of GMP medical equipment compliance, will also be its key year to accept strict supervision of the Administration of Drugs has issued a circular to more than 50% of the first and second category Two randomly open random sampling enterprises, and timely commenced the flight inspection of these two types of machinery enterprises.
Nearly 5,000 first-class enterprises in the country will usher in a drug tycoon inspection storm this year. So, what are the major findings of the first-class medical device manufacturers?
Please read below!
'Dry cargo 'a class of medical device manufacturing enterprises on-site inspection points
A class of medical equipment manufacturing enterprises, because of their products with high safety, low risk of basic features, easy to monitor in the area is not taken seriously.
However, it is because no attention has been given earlier, and the number of reported cases involving a class of medical device products has also been increasing year by year since the establishment of second and third types of enterprises and the registration of products are subject to on-site inspection and system assessment and quality control There is a corresponding basis, and thus the problem is relatively small, while the production of a class of medical equipment companies generally have some problems, such as: the lack of management system, quality management system can not cover the entire process of production, testing, and business records of production and inspection There are also incomplete and non-standard problems, and the factory, warehouse and equipment have not been fully managed in accordance with the regulations. Ex-factory inspection equipment is not measured, there is a serious shortage of staff regulations and regulations, and loose management of personnel are common problems.
In order to better solve the quality management of medical device manufacturing process, according to the "National Food drug Supervision and Administration on medical instruments Production Quality Management Practices Notice (No. 15 of 2014), from January 1, 2018, all medical devices and in-vitro diagnostic reagents enterprise Have to implement the GMP management system.
The following is a key point in the field of medical device manufacturers to check points:
First, institutions and personnel
1. It should be clear that the responsibilities and authorities of various departments, a clear quality management functions.
2. Business leaders should ensure that enterprises in accordance with the law, Regulations And regulations require the organization of production.
3. Should have the appropriate quality inspection agencies or full-time inspectors.
4. Engaged in the impact product quality The personnel who work shall go through the training corresponding to the requirements of their positions and have the relevant theoretical knowledge and practical skills.
Second, plant and facilities
1. Plant and facilities shall be reasonably designed, laid out and used according to the characteristics of the products produced, the technological process and the corresponding cleanliness level requirements.
2. It shall be equipped with inspection sites and facilities suitable for the scale of production, variety and inspection requirements.
Third, equipment
1. Should be equipped with the production of products and the size of the matching production equipment, process equipment, should ensure effective operation.
2. Records of the use of the test equipment and equipment shall be established and the contents of the record shall include the conditions of use, calibration, maintenance and repair.
Fourth, document management
1. Establish and improve quality management system documents, including quality guidelines and quality objectives, quality manuals, procedural documents, technical documents and records, and other documents required by law.
2. The technical documents shall include the technical requirements of the products and related standards, production procedures, operation instructions, inspection and test procedures, installation and service procedures and other related documents.
Five, design and development
1. Design and development outputs should meet input requirements, including relevant information required for procurement, production and service, product technical requirements, etc.
2. Changes in the function of selected materials, parts or products may affect the safety and effectiveness of medical device products, the risks due to the changes should be evaluated, and if necessary, measures should be taken to reduce the risks to an acceptable level, and at the same time Meet the requirements of relevant laws and regulations.
Six, procurement
1. Procurement control procedures should be established.
2. It should ensure that the procurement of goods meet the requirements, and not less than the relevant provisions of laws and regulations and the relevant national mandatory standards.
3. Quality agreements should be signed with major raw material suppliers to clarify the quality responsibilities assumed by both parties.
4. Purchase records should meet traceability requirements.
Seven, production management
1. Production should be carried out in accordance with the established quality management system to ensure that the products comply with the mandatory standards and the technical requirements of the registered or filing products.
2. The preparation of production procedures, work instructions, etc., clear the key processes and special processes.View relevant documents; Whether the key processes and special processes are clear, the key processes and special processes whether the important parameters to verify or confirm the provisions.
3. Each batch of (Taiwan) products should have a production record, and meet the traceability requirements.
4. The inspection status of the product should be identified in the production process to prevent unqualified intermediate product from flowing to the next process.
5. Product traceability procedures should be established that set out the extent, extent, identification and necessary records of product traceability.
6. Product instructions, labels should comply with relevant laws and regulations and standards.
Eight, quality control
1. The inspection procedures of the products shall be formulated according to the mandatory standards and the technical requirements of the registered or filing products and the corresponding inspection reports or certificates shall be issued.
2. Each batch of (Taiwan) products should have batch inspection records, and meet the traceability requirements.
3. The product release procedures, conditions and release approval requirements shall be stipulated.
Nine, sales and after-sales service
Product sales records should be established and traceability requirements met.
Ten, nonconforming product control
The nonconforming product shall be marked, recorded, isolated and evaluated. According to the result of the review, appropriate measures shall be taken for the nonconforming product.
Eleven, adverse events
1. The monitoring system for adverse events in medical devices should be established in accordance with the relevant laws and regulations, carry out monitoring and re-evaluation of adverse events and keep relevant records.
2. Medical devices that have potential safety hazards should adopt measures such as recall in accordance with the relevant laws and regulations and report to relevant departments according to relevant regulations.
3. Management reviews should be conducted on a regular basis to evaluate and review the quality management system to ensure its continued suitability, adequacy and effectiveness.
