The business activities of medical devices shall have business premises and storage conditions suitable for the scale and scope of business, as well as a quality management system and quality management institutions or personnel suitable for the medical devices operated. Engaged in medical device business, should be in accordance with the laws and regulations and the requirements of the medical device business quality management standards formulated by the drug supervision and administration department of the State Council, establish and improve the quality management system, to ensure the effective operation of medical devices.

1. What are the compliance aspects of medical device operation quality management?

1. Quality management institutions and personnel shall have quality management institutions or quality management personnel suitable for business scope and scale, and quality management personnel shall have relevant professional qualifications recognized by the state.

2. The legal representative, the person in charge and the quality management personnel shall be familiar with the laws, regulations, rules and norms of the supervision and management of medical devices and the relevant knowledge of the medical devices they operate.

3. After-sales service personnel shall receive technical training from the production enterprise or other third parties and obtain the after-sales service certificate of the enterprise.

4. Pre-job training: Conduct relevant pre-job training and continuing training for personnel in each position, and establish training records. Only after passing the examination can they take up their posts. The training content should include relevant laws and regulations, professional knowledge and skills of medical devices, quality management system, responsibilities and post operation procedures, etc.

Second, the risk points of medical device management:

1, without legal qualification;

2. The business premises do not meet the business needs;

3. Warehouse management does not meet the storage requirements.

Legal basis: Regulations on the Supervision and Administration of Medical Devices

Article 10 For the filing of Class I medical device products, the filer shall submit the filing materials to the food and drug supervision and administration department of the municipal people's government where the district is located. Among them, the product inspection report can be the self-inspection report of the filing person; Clinical evaluation data does not include clinical trial reports, but it can be data obtained through literature and clinical use of similar products to prove the safety and effectiveness of medical devices. Overseas production enterprises that export Class I medical devices to China shall, through their representative offices established in China or designated enterprise legal persons as agents, submit filing materials and certification documents of relevant competent authorities in the country (region) where the filer is located to the food and drug supervision and administration department of the State Council.