深圳二类医疗器械生产许可证办理

随着现阶段的全面复工，很多有生产力的企业也将重视医疗资源的生产，在企业生产之前需要做的是现要申请相应的医疗器械经营许可资质。俗话说兵马未动需粮草先行，外加一些资质认证办理时间长，手续复杂。所以在企业业务方向确定之后需要马上办理相关资质。而港信通团队对于医疗器经营许可证的办理一向都丰富的经验。

据他们所知办理医疗器经营范围都有以下这些方面：：医疗器械分为3类：A category：类医疗器械有：Basic surgical knives "Scalpel handle and blade、Skin grafting knife、wart peeling knife、lancet、Blade、razor、dandruff scraper、Pick a knife、sharp knife、Shukyakuto、manicure knife、解剖刀等》；Category II：器械：(a)General diagnostic equipment(6820)：thermometer、sphygmomanometer;( b)Physical therapy and rehabilitation equipment(6826)：Magnetic therapy equipment;(c)Clinical testing and analysis instruments(6840)：Home-use blood glucose analyzer and test strips; (d)operating room、emergency room、Clinic equipment and appliances(6854)：Medical small oxygen concentrator portable oxygen generator; (e)Medical hygiene materials and dressings(6864)：Use absorbent cotton、Medical skim gauze; (f)Medical polymer materials and products(6866)：condom、避孕帽等；Category three：medical device：A、Disposable sterile medical devices

1. Disposable sterile syringe;
2. Disposable infusion set;
3. Disposable blood transfusion set;
4. Disposable anesthesia puncture kit;
5. Disposable intravenous infusion needle;
6. Disposable sterile injection needle;
7. Disposable plastic blood bags;
8. Disposable blood collection device;
9. Disposable burette infusion set。

B、Orthopedic Implants Medical Devices

1. surgical implant joint prosthesis;(Disposable sterile medical devices、hearing aid、Contact lenses and care solutions、In vitro diagnostic reagents、6846Implant materials and artificial organs、6877Except for interventional devices)wait。

其中一类，二类不用办许可资质，三类要办许可资质，The required materials are：

1. 三个相关医学专业毕业的本科以上（含本科）文凭产品质量监督检测人员（其中一个为质量检测负责人）；
2. 三个质量监督检测人员的身份证和毕业证复印件、work resume、退工证明；（食品药监局老师过来场地核查约谈的时候需要提供相关检测人员的身份证和毕业证原件，并本人到场）；
3. 所销售医疗器械对方生产厂家的公司营业执照、医疗器械生产企业许可证，医疗器械注册证、医疗器械注册登记表（盖对方公章）；委托销售授权书；
4. 公司法人代表身份证复印件及个人简历；site，50Above average，含体外试剂冷库地址：160Above average。

在知道以上业务范围的细分之后，企业可根据具体的业务快速区分出自己需要办理几类的医疗器械许可证，这样也可以在快速的市场反应中为企业多多争取市场时机。Related products：深圳二类医疗器械生产许可证办理

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