Medical Device Development Suggestion Analysis Gradually Improve Standardization Management

Gradually improve the standardized management of medical devices

Accelerate the update speed of the national standard, solve the problem of classification and cross-cutting, establish a scientific and reasonable medical device standard system, propose to improve the national standard and the update rate of the industry standard for the problem of sampling and inspection; attach importance to and collect the national standard of the loophole or ambiguity through various channels. Relevant provisions and timely revisions.

For the classification problem, it is recommended to improve the classification and coding of medical devices in a timely manner, to solve the problem of non-uniformity and classification of classification principles; at the same time, clarify the hierarchical structure of medical device standards, clarify the principle of standard level setting; optimize the professional distribution of standards; Practical, scientific and reasonable, and forward-looking medical device standard system, so as to comprehensively improve the overall efficiency of medical device standards, better play its technical foundation and technical support, and lay a solid foundation for better national sampling inspection work. .

Continuously improve the quality of registered product standards (product technical requirements)

The status of standards in national sampling is critical and it is an important basis for evaluating product quality. On the one hand, the shortcomings in the current registered product standards, the inconsistent detection methods, and the irregular writing are on the one hand, the pace of the formulation and revision of the national standards should be accelerated, and the industry standards should be unified as soon as possible; on the other hand, it is recommended to strengthen the basic knowledge of standardization. The training, while at the time of registration inspection, gives scientific and reasonable advice on the pre-evaluation of registered product standards (product technical requirements), thereby improving the quality of registered product standards (product technical requirements).

Standardize and improve the level of review and approval. It is recommended to strengthen the business guidance of the examination and approval department, pay attention to the industry dynamics and the update of relevant national standards and industry standards in a timely manner; for medical device products with different evaluation criteria and strict control issues, it is recommended. Formulate a unified review principle; urge the enterprise to update the standard in time and adjust the product structure in the process of review and approval, and carry out supplementary tests on the changed standard items in time to make the products meet the requirements of the new standard.

It is a difficult problem in the national medical device sampling inspection work to continuously improve the registration of product standards for information construction. Some units have doubts about requesting registered product standards, and some units refuse to cooperate. The standard request in the sampling process still consumes a large amount of manpower and material resources of the sampling unit and the inspection unit, which seriously affects the progress of the sampling inspection.

It is recommended that the relevant informationization construction be completed as soon as possible, and the registration system and the registration standard library of the third-class products of medical equipment, the registration information and the registration standard library of imported medical device products, the medical device registration information and the record-keeping standard library of each province are better shared with the supervision system. For regulatory services.

Strengthening the capacity building of medical device testing institutions In 2013, a total of 33 medical device testing organizations participated in the supervision and sampling test. This is the first time. In this process, there is indeed a problem of uneven distribution of medical device testing institutions. Therefore, it is recommended to combine the State Council’s integration testing. Detect the spirit of the certification body, further strengthen the capacity building of each medical device inspection agency, improve the relevant infrastructure for medical device supervision and inspection as soon as possible, optimize equipment allocation, and improve inspection capability and level. Develop a more scientific and reasonable sampling plan.

Taking appropriate measures to improve sampling efficiency, it is recommended to conduct a survey of the distribution of medical device sampling functions and rationalize the business relationship. At the same time, it is recommended to identify the person in charge of medical device sampling and contacts to assess the completion of the sampling work. At the same time, efforts should be made to reduce the Sample rate, to minimize the possibility of sampling the wrong sample.

On the one hand, it is necessary to strengthen the professional training of samplers, standardize operations, and improve the quality and efficiency of supervision and inspection; on the other hand, the naming rules of medical devices should be unified, the names of medical devices should be standardized, and the sampled products can be easily identified from the names. .