1, "Medical Device Business License Application Form";
2, proof of qualification;
3, business license or pre-approval of the business name of a copy of the document certifying;
4, proof of qualification of the quality manager;
5, proof of qualification of after-sales service personnel.
Remarks: The specific processing information is based on local policies.
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Process:
1, the operator of the business enterprise operator with the above information to the municipal people's government of the location of the municipal people's food and drug supervision and management department to apply for a license to operate;
2, Staff to accept the information, and within 30 working days for review, if necessary, the organization verification;
3, in line with the prescribed conditions, permit and issue a medical device license; do not meet the prescribed conditions, not permitted and a written explanation of the reasons.
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Medical device license validity: medical device license is valid for five years.
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Medical device license inquiry: through the enterprise's provincial Food and Drug Administration website to query can be.
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No need to apply for a "medical device business license" medical device product list
1, general diagnostic instruments: thermometers, sphygmomanometers
2, physical therapy equipment: magnetic therapy appliances
3, medical hygiene materials and dressings: medical skimmed cotton, medical skimmed gauze, medical sanitary masks, sterile gauze
4, clinical clinical materials and dressings: medical skimmed cotton, skimmed gauze, sterile gauze
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The medical equipment business license inquiry: through the enterprise's provincial Food and Drug Administration website can query. p>
4, clinical testing and analysis instruments: home blood glucose meter, blood glucose test strips, pregnancy diagnostic test strips early pregnancy test side test strips
5, medical polymer materials and products: condoms, contraceptive caps
6, ward care equipment and appliances: wheelchairs, Chapter II Application for "Medical Device Business License" conditions
Article 6 The application for the "medical device business license" shall be accompanied by the following conditions Enterprise License" shall have the following conditions:
(a) with the scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(ii) with the scale and scope of operation of relatively independent premises;
(iii) with the scale and scope of operation of storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of the medical device products;
(iv) shall be Establish and improve product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and reporting system of adverse events;
(e) should have the appropriate technical training and after-sales service with its business medical device products, or agreed to provide technical support by a third party.