Apply for medical device production license in Shenzhen

彭易Aaron说深圳办理医疗器械生产许可证:如果您的企业是医疗器械行业的话，那么一定要办理医疗器械许可证。在办理医疗器械许可证中如果您有难以整理的地方可以咨询港信通国际。Hong Kong Xintong International has 13 years of experience in qualification processing，Can provide you with professional qualification business services。

以上是港信通国际在以往办理医疗器械时的一些经验：

1. 《医疗器械生产许可核发申请表》
2. 营业执照（A类有限责任公司）；
3. legal representative、Identity certificate of the person in charge of the company，Education certificate or professional title certificate，任命文件的复印件和工作简历；
4. 生产场地证明文件，Include a copy of the property certificate or lease agreement and the lessor’s property certificate；Factory general plan，Main production workshop layout diagram，clean

Require

workshop，需提供洁净室的合格检测报告复印件，标明功能间及人物流走向；

1. 企业的生产、technology、质量部门负责人的简历、学历证明或职称证明的复印件；
2. Production management、Educational qualifications of employees in quality inspection positions、List of professional titles；
3. 主要生产设备及检验仪器清单；
4. 生产质量管理规范文件（包括质量手册和程序文件）目录；
5. 产品的工艺流程图，And indicate the main control items and control points，Including equipment for critical and special processes、Description of personnel and process parameter control；
6. When applying for enterprise declaration materials，The person handling the matter is not the legal representative or person in charge himself，The enterprise should submit a "Power of Attorney"；
7. 申请材料真实性的自我保证声明，Including the catalog of application materials and the company's commitment to bear legal responsibility if the materials are false.，申请检查确认书；
8. 中华人民共和国医疗器械注册证和产品技术

Require

。

申请这类资质一定注意的是在规定的工作日完成资料提交，如果错过时期在进行补缴资料的话那将会很麻烦。如果您对

Application process

不熟悉的话。建议您咨询专业的第三方专业资质办理公司港信通国际为您办理。Related products：Apply for medical device production license in Shenzhen

About Hong Kong Xintong

Hong Kong Xintong focuses onGuangdong and Hong Kong license plates、Shenzhen Hazardous Chemicals Business License、Shenzhen labor dispatch licenseandShenzhen Charity Foundationapplication services，Assist customers to applyShenzhen travel agency business license、Shenzhen pawn shop business license、Shenzhen auction house license and other mainstream domestic financial licenses，Support enterprises to achieve compliance expansion of cross-border financial business。Also availableODI overseas investment registration、International travel agency registration and other services，Help enterprises expand their presence in international markets。Provide one-stop compliance solutions for enterprises。To learn more，Please contactHong Kong Information Communications Consultant。