A, publicity:
1, self-built websites, APP and other promotional medical devices, need to apply for the Internet drug information service Qualification certificate.
2, in other platforms to promote medical devices, need medical device advertising review form. (such as Baidu promotion, etc.)
Two, sales:
1, stationed on the platform (such as Taobao, Tmall, Pinduoduo, etc.) to sell medical devices, the platform side will require companies to provide medical equipment network sales record certificate.
2, the enterprise to build a website or APP to sell medical devices, need to provide medical device network sales record and Internet drug information service qualification certificate.
3, the enterprise to build a three-party platform for buyers and sellers to buy and sell medical devices, need to provide medical equipment network sales third-party platform filing.
Three, for advertising review form, medical device network sales record, Internet drug information service qualification certificate and medical device network sales of third-party platform for the record the process of materials needed: to Beijing as an example
1, advertising review form:
Processing unit for: the Beijing Municipal Bureau of Pharmaceutical Supervision
Processing procedures are: application acceptance (2 working days) --Review and decision (10 working days) --Awarding and delivery (10 working days)
Required materials: advertising review form (official website has a sample form), with the release of the content of the advertisement samples, the applicant's qualifications related to the main body of the materials. Or legally valid registration documents (including the "Business License", the contact person's identity documents, "Medical Device Manufacturing License", "Class I Medical Device Manufacturing Record Form", "Medical Device Business License" or "Class II Medical Device Business Record Voucher"), authorization documents (for the holder of the product registration certificate or record voucher authorization to agree to the manufacturer or operator as the applicant) Documents), the applicant entrusted agent's power of attorney and the main qualification materials, product registration and filing materials (including "Medical Device Registration Certificate", "Class I Medical Device Filing Certificate", "Medical Device Manufacturing License" or "Class I Medical Device Manufacturing Filing Form", registered and filed product product labels and product specifications), advertisements involving intellectual property rights and effective approval of the material (including trademarks, patents, copyrights, etc.). certificate, patent documents, copyright documents and other documents), the authenticity of the enterprise guarantee materials.
2, medical device network sales record:
Processing unit for: Beijing XX Market Supervision Bureau
Processing procedures: can be accepted on the spot or through the on-the-spot corrections to meet the acceptance of the conditions, directly into the acceptance of the steps on the spot to issue acceptance notices, meet the requirements of the decision to make the administrative licensing; does not meet the requirements of the decision not to make the administrative licensing.
These are the first steps in the process.
Required materials: "Medical Device Network Sales Information Form" (official website has a sample form), business license, legal representative ID card, medical device license (or medical device manufacturing license or Class II medical device business filing credentials, the applicant belongs to the self-built class of Web sites should be provided: Internet drug information service qualification certificates, telecommunication business licenses (if any) and Non-operational Internet information service filing instructions (non-operational Internet information service filing instructions that the ICP filing screenshot and website introduction), the applicant enterprise belongs to the stationing category of the website, should provide: all proposed to be stationed in the medical device network trading services third-party platforms to sign a stationing agreement, the applicant enterprise to declare the material, the specific processing personnel is not the enterprise's legal representative, the enterprise should be submitted to the letter of authorization.
3, Internet drug information service qualification certificate:
Processing unit for: Beijing Municipal Drug Administration
Processing process: application acceptance (2 working days) - review and decision (13 working days) - Issuance and delivery (10 working days)
Required materials: Internet drug information service application form and the Beijing Municipal Government Service Matters based on the application to inform the commitment, business license (original and duplicate), website domain name registration certificate, non-operational Internet information service filing instructions (if any), telecom business license (if any), the person in charge of the site and drug or medical device information reviewer Graduation certificate or professional and technical qualification certificate, ID card, the basic introduction to the website (including: business model, website column settings and operational functionality description), the Internet drug information service management document directory, apply for corporate filings, the specific handling personnel are not the legal representative of the enterprise, the enterprise should submit a letter of authorization.
4, medical device network sales third-party platform for the record:
Processing unit for: Beijing Municipal Drug Administration
Processing procedures for: application acceptance (on-site acceptance) - review and decision (1 working day) -Awarding and delivery (0 working days)
Required materials: medical device network trading services third-party platform filing form (provided by the official website), business license, legal representative ID card, the main person in charge of ID card, medical device quality and safety manager ID card and academic certificate (or professional and technical qualification certificate), non-business Internet information service filing Description, telecommunications business license (if any), the certificate of property rights or lease agreement (with a copy of the certificate of property rights of the house), organizational structure and departmental setup description and office location map, medical device network trading service quality management system directory, the website or network client application basic information and functional description, apply for the enterprise to declare the material, the specific processing personnel is not the legal representative of the enterprise , the enterprise should submit a power of attorney!