办理医疗器械经营许可证条件和流程需要多少钱

Medical device operating enterprise license application conditions and procedures?需要多少钱？

Is the application form for a medical device operating enterprise license complicated??How long does it usually take to get it done??Are there any discounts for licensing??Conditions for starting a medical device business enterprise：one、personnel：

1. The full-time quality managers of Category III medical device operating enterprises should have a college degree or above or an intermediate professional title or above.;
2. 第三类医疗器械经营企业不低于100万元
3. 第三类医疗器械经营企业质量检验人员应具有大专以上学历或中级以上职称;
4. Enterprises involved in retailing household therapeutic products or Class III implantable devices should be staffed by personnel with certain medical technical qualifications。

two、Business premises：

1. Business premises：Generally, the area used by enterprises is not less than 40 square meters.，Residential buildings cannot be used as business premises for enterprises;Retail business enterprises must be front houses;
2. Warehousing conditions：Generally, the area used by enterprises is not less than 20 square meters.，Residential buildings cannot be used as storage spaces for enterprises;
3. Business single use sterile、Companies that produce special medical devices such as implants must have self-managed warehouses，Storage conditions should comply with product standards.

Require

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办理医疗器械经营企业许可证要看你是办理几类的医疗器械，每一类的

Require

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