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On the issuance of "national quality supervision and testing of medical devices management (Tr by na b
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On the issuance of "national quality supervision and testing of medical devices management (Tr by NA B
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| Article Posted: 12/10/2010 |
| Article Views: 61 |
| Articles Written: 2638 - MORE ARTICLES FROM THIS AUTHOR |
| Word Count: 804 |
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On the issuance of "national quality supervision and testing of medical devices management (Tr |
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Business,Business News,Business Opportunities
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Provinces, autonomous regions and municipalities directly under Food and Drug Administration (Drug Administration), Pharmaceutical and Biological Products, State Food and Drug Administration, the Medical Device Quality Supervision and Inspection Center:
To strengthen supervision and management of medical device product quality, standardized quality control testing of medical devices work, the State Council formulated the "National Medical Device Quality Supervision and testing management (Trial)", is issued to you, please comply. The Problems please report the State Council.
State Food and Drug Administration National quality supervision and testing of medical devices management (Trial)
Chapter I General Provisions First medical device to enhance product quality supervision and management, standardized quality control testing of medical devices work, according to "Medical Devices Regulations" (hereinafter referred to as "Regulations") and related regulations, the enactment of this provision.
Article The term national quality supervision and testing of medical devices is by the State Food and Drug Administration (hereinafter referred to as the State Board) to organize food and drug supervision and management departments at all levels (hereinafter referred to as Drug Administration department) and take the national medical equipment the testing of Quality Supervision, medical device inspection authorities (hereinafter referred to as bearing inspection agency), for medical equipment for sampling, testing, and testing results according to notice and regulatory activities.
This Article shall apply to the PRC Drug Administration department, bearing inspection agencies, as well as in medical equipment production, management and use of the unit. Article
testing medical devices are divided into assessment of Quality Supervision, testing and monitoring of testing. Evaluative testing refers to grasp and understand the overall quality of medical device testing conducted by the situation. Supervision of testing is to monitor the quality of medical devices for the testing. State Bureau of the testing to evaluate the nature of testing the main provincial Bureau of the testing to monitor the testing of the main. Article
determine the quality of medical devices were seized products, according to national standards, industry standards, product standards and state registration requirements.
State shall supervise the quality of medical devices testing samples from the sampling units are provided free of charge, the number of samples should conform to the requirements of the random testing program.
National medical devices quality test of charge.
Article VII by the State Quality Supervision and testing medical devices qualified products, no special circumstances, one year from the date of sampling, the levels of drug supervision departments of the same enterprise may not be repeated with a product sample testing.
Chapter plans and programs Article VIII of the State Bureau
seek the views of interested parties, based on the need for annual inspection under the supervision and quality control testing of medical devices program. Testing program to determine species
Article fundamental principles: (A) potential risk to humans, its safety and effectiveness of medical devices must be strictly controlled;
(B) of the market with quality problems for medical devices;
(C) quality control testing of medical devices convicted of unqualified medical instruments;
(D) other key monitoring medical equipment.
Article implementation program testing program testing should be developed by the Pharmaceutical and Biological Products (hereinafter referred to as the testing laboratory) responsible for the development. Testing program should include sampling scope, method, volume, or standard test basis, test items and determining principles.
Sample chapter Article Drug Administration Department to carry out random medical devices, it should be sent two or more (including 2) supervision and inspection and sampling of medical devices (hereinafter referred to sampling personnel) to implement.
Sampling personnel should receive professional skills training, regulations, and sampling, and remained stable in a certain period of time.
Article XII random sample of staff in the implementation of the mandate, the administrative law enforcement should take the initiative to produce documents or sending the certificate document, and produce the sample files.
Article XIII of the sample units shall assist to carry out random sampling and show the following information required to provide originals or copies of:
(A) of the medical device manufacturer should provide the medical device manufacturer license, medical devices are taken from the product registration card, product standards, production records, inspection reports, production, inventory, sales and sales records and other related information;
(B) of the medical device business enterprises shall provide the medical equipment business enterprise license, medical devices are taken from product registration cards, certificates and other identification, purchase, inventory, sales and marketing records, inspection records and other related information; I am an expert from Components Electronic suppliers, usually analyzes all kind of industries situation, such as furniture rattan wicker , wire hanging basket.
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