Shenzhen medical device business license application/conditions for starting a medical device business enterprise

Medical device operating companies describe in detail the methods used to deal with existing problems、go through、Involving medical equipment and personnel，Carefully formulate corrective measures and plans，Form a self-examination and rectification report，Submit to the local districted municipal food and drug regulatory department。The legal representative of the enterprise must sign the report，Stamped with official seal，and verify the authenticity of the report、Completeness and rectification commitments。If not reported due，The list of companies will be disclosed to the public，Listed as key inspection objects。

Refusal to report、False reporting and concealment of reports and failure of self-examination、Inadequate rectification，strict、from re-investigation，Until the "Medical Device Business License" is revoked。The circumstances are serious and suspected of committing a crime，will be handed over to the public security organs。Conducting serious illegal and untrustworthy conduct on medical device operating enterprises，Implement joint punishment in accordance with relevant regulations。

Shenzhen Business Co., Ltd. Hong Kong Xintong-Address：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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Medical device license conditions———–港信通-医疗器械许可证

Process

———–港信通-医疗器械许可证办理周期———–港信通-医疗器械许可证办理

cost

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