Medical equipment
industry development in the
past two years the hot, many local governments have stepped up the field
support, hope that through the spring breeze of the cure of the local medical
equipment industry developed. Recently, from the administration's kunming have
learned, only the first half of this year of kunming issued registration
certificates 45 class I medical devices, of which the first registered a newly
registered, 44.
This data is quite gratifying, compared to previous years had the very big enhancement. Such registration review is very strict, first registered variety classification accuracy, registration data is true and effective, and all varieties through the registered inspection. Medical device registration check, is to ensure that the authenticity of the enterprise application material, avoid fraudulent false declaration of important regulatory means. In accordance with the relevant documents GuoGuJu factories in kunming regulations, implement medical device registration for verification. Focus on whether the existing medical equipment according to medical equipment is declared or high class low cross;
The kind of medical device manufacturing enterprise registration form ", whether they contain the variety; Ensure that the main body of the administrative licensing legal; Directly used to gb and line mark, or the enterprise standard (registered product standards) cited corresponding mandatory national standard and professional standard is no current effective; Key check whether a enterprise performance test all the test conditions; Entrusted by the inspection of, whether to have entrusted inspection agreement, be entrusted inspection institutions have inspection conditions; The enterprise existing resources and quality management ability (including detection means)
Article: from perlong medical (http://www.pl999.net)
Attention: if you want to copy this article , you must attach the website.
This data is quite gratifying, compared to previous years had the very big enhancement. Such registration review is very strict, first registered variety classification accuracy, registration data is true and effective, and all varieties through the registered inspection. Medical device registration check, is to ensure that the authenticity of the enterprise application material, avoid fraudulent false declaration of important regulatory means. In accordance with the relevant documents GuoGuJu factories in kunming regulations, implement medical device registration for verification. Focus on whether the existing medical equipment according to medical equipment is declared or high class low cross;
The kind of medical device manufacturing enterprise registration form ", whether they contain the variety; Ensure that the main body of the administrative licensing legal; Directly used to gb and line mark, or the enterprise standard (registered product standards) cited corresponding mandatory national standard and professional standard is no current effective; Key check whether a enterprise performance test all the test conditions; Entrusted by the inspection of, whether to have entrusted inspection agreement, be entrusted inspection institutions have inspection conditions; The enterprise existing resources and quality management ability (including detection means)
Article: from perlong medical (http://www.pl999.net)
Attention: if you want to copy this article , you must attach the website.
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