Class II medical devices without license penalties

The class II medical device is mainly for the safety and effectiveness of medical devices, for which China's production of class II medical devices have very strict requirements, without authorization shall not be produced. Therefore, the next step will be introduced by you on the class II medical device without a license penalties and its related aspects of knowledge, I hope to be able to help you solve the corresponding problems. First, class II medical devices without a license penalty

In the absence of a business license to sell Class II medical devices is certainly illegal, there must first be a medical device license to sell.

Second, open the conditions of the second class of medical device manufacturers

open the second class of medical device manufacturers must have the following conditions:

(a) The person in charge of the enterprise should have secondary education or more junior title.

(b) The person in charge of the quality inspection organization should have college education or above, or intermediate or above title.

(c) The enterprise should occupy the corresponding proportion of the total number of employees above the junior title of engineering and technical personnel.

(d) The enterprise should have the appropriate product quality inspection capabilities.

(e) There should be with the production of products and scale of production, warehousing sites and environment.

(F) has the appropriate production equipment.

(vii) The enterprise should collect and save and enterprise production, business-related laws, regulations, rules and relevant technical standards.

(h) the production of sterile medical devices, should have a production site in line with the provisions.

Third, Medical Device Manufacturer License Application Process

Provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration received an application, should be based on the following circumstances were dealt with:

(a) the application does not belong to the department's terms of reference, it should be made immediately inadmissible decisions, and inform the applicant To the relevant administrative organs;

(ii) application materials can be corrected on the spot errors, the applicant should be allowed to correct on the spot;

(iii) application materials are incomplete or do not meet the requirements of the formal review, it should be issued on the spot or within five working days to the applicant, "Supplementary Material Notice", a one-time notification to the applicant needs to make corrections to all the contents of the application materials are not notified of the delay, since the receipt of Application materials from the date of receipt is accepted;

(d) application materials are complete, meet the formal review requirements, or the applicant in accordance with the requirements to submit all corrective application materials, be accepted.

Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments to accept or not accept the application for the start-up of medical device manufacturers, should be issued with the department's acceptance of the special seal and the date of the "Notice of Acceptance" or "Notice of Inadmissibility.

After reviewing the provisions of the written decision to grant a license, and within 10 working days to the "medical device manufacturer license. After review does not meet the requirements of the written decision not to issue a license, and explain the reasons, while informing the applicant of the right to apply for administrative reconsideration according to law or the right to file an administrative lawsuit.

According to the law can be known, in the absence of business license to sell Class II medical devices is certainly illegal, must first have a medical device license to sell.