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| Nanjing, Jiangsu Province Food and Drug Administration standards for medical devices to enhance the implementation of enterprise monitoring |
To further strengthen the national medical equipment, the implementation of industry standards, improve the scientific supervision of the city's level of medical equipment, medical devices to ensure that the property is safe and effective, Nanjing, Jiangsu Province Food and Drug Administration issued a "serious implementation of the medical device on the national, industry standards and strengthen the supervision of the notice ", to further strengthen the implementation of medical device companies of national standards, industry-standard monitoring.
Notification requirements, enterprises should strengthen the implementation of national standards and awareness of the subject line. Stressing the importance of medical device manufacturers is to carry out the national, industry-standard first responsible person. The new standard is published, and the enterprises should promptly carry out product design changes and amendments to such registration standards, to ensure the medical devices and the implementation of standards, reference standards to meet the new standards. Since medical devices national and industry standards from the date of the formal implementation of all relevant medical equipment manufacturing enterprises should follow the standard requirements of new manufacturing and testing organization, such as the State Food and Drug Administration in accordance with regulations made or requirements necessary for type test and (or) re- registration should be completed within the prescribed time limit accordingly.
The circular stresses the implementation of localization and monitoring the effectiveness of implementing standards to enhance business. Clear the county Food and Drug Administration (Branch) the state, Xingye standard implementation of the circumstances as an area of medical monitoring equipment manufacturing enterprises Richang an important part of Chongdianjiancha manufacturers are Jubei national, industry-standard requested production and test Tiao Jian, timeliness in accordance with the standards to organize production and testing work, do not meet the above requirements shall order rectification and investigated according to law. That have been published or are about to implement the national and industry standards should be enhanced, as soon as possible to urge the enterprises make preparations for the implementation of new standards, to ensure timely implementation.
Notice requirements, the District Food and Drug Administration (Branch) and the medical device manufacturer to arrange for staff for the State of medical devices, industry standard release, the revision tracking the trend, the establishment of relevant national, industry-standard file timely collect national, industry-standard paper or electronic text, and national and industry standards, as regulators and corporate training business to learn important content, improve the country, understanding and mastering of industry standards |
| AddTime：2010-7-8 11:20:14 |
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