1, a copy of the business license;
2, the legal representative, the person in charge of the enterprise, the person in charge of quality of the identity of the person, a copy of the certificate of qualifications or titles;
3, the enterprise organization and departmental setup instructions;
4, the scope of business, the business model Description;
5, business premises, warehouse address of the geographic location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) copy;
6, business facilities and equipment directory;
7, authorization;
8, other.
The use of the Internet to promote medical devices need to apply for certificates of qualification:
1, if you build their own website, APP, etc. to promote medical devices need to apply for the Internet drug information service qualification certificate, the need for companies to provide offline medical device qualification certificates, the second class of filing or the third class of the production license, the need to provide ICP license or ICP filing screenshots;
2, if the use of other platforms to promote medical devices, you need to provide and the platform signed a stationing contract, medical device advertising review form, need to provide offline medical device qualification certificates, Class II filing or Class III production license and need to provide ICP license.
Legal basis
"Regulations for the Supervision and Administration of Medical Devices"
Article XII engaged in the operation of Class II medical devices, the business enterprise shall be located in the municipal food and drug supervision and management department for the record. Article XVII set up warehouses across administrative areas, should be the location of warehouses to the municipal food and drug supervision and management department for the record. Article 30 is engaged in the second class of medical equipment business, by the business enterprise to the municipal people's government where the municipal food and drug supervision and management department for the record.
Measures for the Administration of Registration of Individual Business Names
Article 11 The name of an individual business shall not contain the following contents and words:
(1) detrimental to the state, social public **** interests;
(2) violation of social order and morals, and does not respect national and religious customs;
(3) may cause deception or public misunderstanding;
(4) the names of foreign countries or regions, international organizations;
(5) the names of political parties, party, government and military organs, mass organizations, associations and their abbreviations, and troop numbers;
(6) the names of "China", "China", "China", "China", "China", "China", "China", "China", "China", "China", "China", "China", "China", "China", "China" and "China". China", "China", "national", "country", "international" words;
(7) Hanyu Pinyin, alphabets, foreign characters, punctuation;
(viii) language and writing that do not conform to national norms;
(ix) other contents and words prohibited by laws and regulations. Article XII individual business households apply for name registration, the business scope involves registration of prior authorization, shall apply for pre-approval of the name. The applicant shall apply for pre-approval of the name approved by the registration authority to the relevant departments for prior approval procedures. Scope of business does not involve prior authorization, you can apply for pre-approval of the name, you can also apply for registration with the establishment of an individual business or change. Registration authority for name pre-approval, shall not charge a fee. Article 13 An application for pre-approval of the name of an individual industrial and commercial enterprise shall be submitted by the applicant or the applicant's authorized agent to the registration authority where the place of business is located with the following materials:
(1) application for pre-approval of the name of the individual industrial and commercial enterprise;
(2) proof of the operator's identity;
(3) if the operator entrusts an agent to do the work, the operator shall also submit the letter of attorney and the agent's proof of identity. Proof of identity of the agent.