Standard plays a very important role in the country to sample, it is the important basis to evaluate the quality of the product. For missing items that exist in the currently registered product standard, testing method is not unified, writing is not standard, on the one hand, should accelerate the pace of legal channels standard formulation and revision, as soon as possible, a unified industry standard; On the other hand, it is suggested that strengthening the standardized training of basic knowledge, at the same time at the time of registration for registered product standard (product specification) the pre-assessment of the scientific and reasonable advice, so as to improve the quality of the registered product standard (product specification).
Specification to improve the review level Suggestions to strengthen the review of examination and approval department for examination and approval of business guidance, timely attention to industry dynamic and update situation of relevant national standards, industry standards; For existing review size is differ, lax and other issues of medical equipment products, suggest to formulate unified principle of review; In the review process of examination and approval to urge enterprises to update the standard and adjust the product structure, to change the standard project in a timely manner to supplement tests, make products to meet the requirements of the new standard.
Constantly improve registration product standards for information construction difficulty is calendar year national medical apparatus and instruments to sample problem. Some units to ask for the registered product standard, some units have refused to cooperate. Sample standard for still in the process of cost a great deal of sampling unit, inspection unit of manpower material resources, the serious influence to sample progress.
Suggestions to complete the related information construction as soon as possible, for regulatory system Shared third class medical device product registration information and put on record the standard library, imported medical equipment product registration information and put on record the standard library, provincial medical instrument registration information and put on record the standard library, better service for regulation.
To strengthen the construction of ability of medical device testing institutions in 2013, a total of 33 medical device testing institutions involved in the supervision of proper, this was the first time, did exist in the process of medical device testing institutions ability distribution problems, it is recommended that combination of the state council on the spirit of integration testing certification institutions, further strengthening the construction of the ability of medical equipment inspection institutions, perfect the medical equipment supervision, inspection and related infrastructure, as soon as possible to optimize the equipment configuration, improve the capability and level of inspection. To develop a more scientific and reasonable to sample solution.
Take corresponding measures to improve the efficiency of sampling Suggestions to carry out the functions of medical apparatus and instruments to sample distribution of baseline investigation, and smooth business relationship; Also suggested that identified and contacts, head of the medical instrument sampling, the sampling work completion inspection; At the same time, try to decrease the rate of return sample, to minimize the possibility of fault samples.
On the one hand, to strengthen the sampling personnel professional training, standardized operation, improve the quality and efficiency of supervision and inspection work; On the other hand, should be unified medical equipment naming rules, norms of medical equipment, the name of the sampling of products is easy to identify from the name.