How to handle the medical device record

Medical device filing process is as follows:

1, online application. The applicant should be submitted through the online application for pre-approval, the enterprise in the submission of paper application materials shall be submitted at the same time the pre-acceptance number;

2, the window acceptance. Enterprises to submit paper applications to the window, receiving and accepting personnel to verify the application materials, on the spot to make a decision on acceptance;

3, on-the-spot review. After acceptance, the reviewer to review the materials, make a decision on the spot review;

4, get the results. The applicant in the window on the spot to receive "the first class of medical devices production record voucher" or "do not pass the decision.

The following information is required to apply for the medical device business record voucher:

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 card, a copy of the certificate of qualifications or titles;

3, the enterprise's organizational structure and departmental setup description;

4, the scope of business, the business mode description

5, business premises, warehouse address 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.

Legal Basis

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 interests of the state and the social public ****;

(2) violating the social order and morals and disrespecting the national and religious customs;

(3) May cause deception or misunderstanding to the public;

(iv) the names of foreign countries (regions), international organizations;

(v) the names of political parties, party, government and military organs, mass organizations, associations and organizations and their abbreviations, and the number of the troops;

(vi) "China", "Chinese", "national", "state", "international";

(vii) Hanyu Pinyin, alphabets, foreign characters, punctuation marks;

(viii) language and writing that do not conform to the 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.