深圳二类医疗器械生产许可证办理，深圳二类医疗器械备案在哪申请

随着时间的慢慢推移人们都自身健康安全也越加的重视了很多，这也从侧面催生了医疗器经营企业的发展。面对口罩、酒精、Forehead thermometer、消毒酒精等需求的增大，相比会有很多企业都会加入到医疗企业经营行业中来，满足市场需求的同时也能更好的发展市场经济。那么想要经营医疗器械的企业，办理相关证件您清楚吗？

如果有疑惑的话，请您关注港信通团队为您整理的一项详细内容：企业想要经营医疗器械，那么久必须要具备《医疗器械经营许可证》 。

具体申请材料分为：

1. The "Medical Device Business Enterprise License Application Form" submitted by the operating enterprise should be signed by the legal representative or stamped with the official seal of the enterprise.；
2. The items filled in the "Medical Device Business Enterprise License Application Form" should be filled in completely、precise，The content to be filled in should comply with the following

Require

。A、"Company name"、The "registered address" is the same as the "Industrial and Commercial Business License" or "Notice of Pre-Approval of Enterprise Name"。

B、The business scope to be applied for shall be filled in according to the first-level catalog of the "Medical Device Classification Catalog" issued by the State Food and Drug Administration in 2002.。C、"Registered Address"、When filling in the "warehouse address", the specific house number should be clearly stated.、Floor and room number。

1. Proof of identity of legal representative、Certificate of academic qualifications and professional title、The appointment document should be valid；
2. The copy of the "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the industrial and commercial administration department should be the same as the original，Copy to confirm and keep，Originals returned；
3. Property certificate、房屋租赁证明（出租方要提供产权证明）应有效；
4. Business person in charge、Quality manager resume、Educational qualification certificate or professional title certificate should be valid；
5. Enterprises should establish medical device quality management files or forms based on their own actual conditions。
6. The self-guarantee statement on the authenticity of the application materials should be signed by the legal representative and stamped with the official seal of the company.，If there is no official seal，The signature or seal of the legal representative must be。
7. All application materials need to be submitted with copies，申请人（单位）须在复印件上注明“此复印件与原件相符”字样或者文字说明，Date，Stamped with the official seal of the unit；Individual applications must be signed or stamped。
8. Application materials should be complete、clear、signature，And stamp each copy with the official seal，All application forms are typed and filled out by computer，Print on A4 paper，Use A4 paper for copying，Bind into a volume according to the order of the application materials catalog。

准备好以上材料就可以进行申请《医疗器械经营许可证》了，但是在申请之前如果您还有未尽知晓的问题随时都可以咨询港信通团队，随着现在医疗器械企业注册的企业常态化，港信通团队可以为你提供专业高效的商务代理。

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