This is according to the "supervision and management measures for the online sale of medical devices" issued by the State Food and Drug Administration (SFDA), which specifies that the format of the filing certificate for the third-party platform for online trading services of medical devices shall be uniformly formulated by the SFDA, and then the provincial food and drug supervision and management departments shall be responsible for the printing of the certificate. Therefore, if you need to apply for or inquire about the record voucher, it is recommended to directly contact the provincial food and drug supervision and management department or relevant organizations in your location.
The information required to apply for the medical device business record certificate mainly includes:
1, a copy of business license.
2, the legal representative, the person in charge of the enterprise, the quality of the person in charge of the identification, education or title certificate copy.
3, the enterprise organization and departmental setup description.
4, business scope, business mode 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 catalog.
7. Authorization letter.
In summary, depending on the specific mode of operation and business scope, other information may need to be submitted. For example, for enterprises wholesaling Class II medical devices (including in vitro diagnostic reagents), the area used for operation, the area used for storage and the volume used for cold storage need to reach a certain standard, and they need to submit professional certificates of the quality management personnel and a directory of documents such as working procedures that are in line with the actual work of the enterprise. For enterprises wholesaling Class II medical devices (excluding in vitro diagnostic reagents), the person in charge of quality needs to have relevant professional qualifications or technical titles.
Legal basis:
Measures for the Administration of Registration of Individual Business Names in the People's Republic of China
Article 11
The name of an individual business shall not contain any of the following contents and words:
(1) those that are detrimental to the interests of the state and the social commons;
(2) those that violate the social commons, and those that don't respect the nationalities and religious customs;
(3) those that may cause deception or misunderstanding to the public;
(4) the names of foreign countries (regions) and international organizations;
(5) the names of political parties, party, government, and military organs, mass organizations, and organizations of associations and their abbreviations, as well as the numbers of troops;
(6) the names " China", "Zhonghua", "National", "State", "International " words;
(vii) Hanyu Pinyin, alphabets, foreign characters, and punctuation marks;
(viii) words and phrases that do not conform to the national norms;
(ix) other contents and words prohibited by laws and regulations.
Article 12
Individual industrial and commercial households applying for registration of their names shall apply for pre-approval of their names if their business scope involves pre-registration license. The applicant shall submit the name approved by the registration authority to the relevant departments for pre-approval procedures.
Business scope does not involve prior authorization, you can apply for pre-approval of the name, you can also apply for registration with the establishment of individual business or change.
Registration authority for name pre-approval, shall not charge a fee.