台;其中提供验配服务的,经营场所使用面积不得少于30平方米,验光室(区)应具备暗室条件或满足无直射照明的条件。
4.经营除上述类代号以外其他三类类医疗器械的,经营场所使用面积不得少于60平方米,并配备与经营规模相适应的仓库。提供材料:
1、企业名称与经营范围,注册资本及股东出资比例,股东等身份证明;
2、医疗器械产品注册证书、供应商营业执照、许可证及授权书;
3、质量管理文件等;
4、2个或以上医学专业或相关专业人员证书、身份证明与简历;
5、符合医疗器械经营要求的办公场地及仓库证明; 6、公司章程、股东会决议等;
7、财务人员身份证和上岗证;8、其它相关材料。
1、提交的材料不同的食药所会有不同的差别,具体以现场核查为准。
2、第二类医疗器械经营备案凭证的申请都需要现场核查,一切情况以现场核查为准。3、医疗器械经营许可的申请
ee types of medical devices other than the above-mentioned codenames, the use area of the business site shall not be less than 60square meters, and it shall be equipped with warehouses suitablefor the business scale. Provide materials: 1. Enterprise name andbusiness scope, registered capital and proportion of shareholdercontribution, shareholders and other identity certificates; 2.Medical device product registration certificate, supplier businesslicense, license and authorization letter; 3. Quality managementdocuments, etc.; 4,2 or more certificates, identificationcertificate and resume of medical professionals or relatedprofessionals; 5. Certificate of office space and warehouse meetingthe business requirements of medical device operation; 6. Articlesof association, resolutions of shareholders' meeting, etc.; 7. IDcard and post card of financial personnel; 8. Other relevantmaterials. 1. There will be different differences in different foodand drug submitted materials, and the specific ones is subject toon-site verification. 2. The application for the business recordcertificate of category II medical devices requires on-siteverification, and all information shall be subject to on-siteverification.3. Application for the business license of medicaldevices