Medical Class 3 Qualification

What are the application conditions for a Class 3 medical device license? Three types of medical equipment business license to declare what?

Application conditions and procedures 1, to apply for three types of medical equipment business license, there must be a relevant business license, general business license on the business scope of this column, need to clearly write can sell three types of medical equipment. If not, you need to go to the Trade and Industry Bureau for additions.

2, the sale of Class III medical devices, you must have their own warehouse, and the warehouse needs to be set up in the cold storage, because Class III medical devices, there is a need for insulation, more than a certain temperature, it is easy to deteriorate the quality of the product, so very few dealers have the qualifications to sell Class III medical devices.

3, go to the Trade and Industry Bureau for the addition, it is necessary to bring the Trade and Industry Bureau staff to view the warehouse, you better clean up the warehouse, and then get the "Medical Device Business License Application Form" and fill out, and all the relevant qualifications of the enterprise, but also need to bring the quality of the relevant information.

4, three types of medical equipment business license, you need to go directly to the municipal drug supervision and management department for the acceptance of information within 30 days after the audit, if in line with the relevant provisions, you can issue three types of medical equipment business license.

Medical device license for personnel requirements:

1, the legal person who is also the person in charge of the enterprise needs to have a college degree or above, the professional does not require

2, the person in charge of quality needs to have more than 3 years of work experience, college education, graduated from a related professional

Medical device-related professions refer to: medical devices, biomedical engineering, mechanical, electrical, medical, bioengineering, Chemistry, Nursing, Rehabilitation, Laboratory Science and other specialties.

Medical device license process:

1, the declaration of information through the window audit (window audit is mainly to review the format and information is complete, of course, in general, the teacher will talk to you a little more carefully, to avoid you more run, anyway, once or twice is not all the report);

2, the background audit, the information is received by the window to give you out of the admissibility of notification, the information forwarded to the audit department. Department, if the information by the problem will be returned back to the declaration stage, if the information is qualified within seven days will be sent to the inspection team.

3, inspection, the Drug Administration to organize inspections, unqualified rectification reapply for inspection, qualified report,

4, the certificate, with the application form to the Drug Administration to receive the certificate, the big success. Need to focus on the medical device license all the information needs to be uploaded to the State Drug Administration website, so do not want to leave it to chance, because the City Council can not take this responsibility.

Medical device license for the required materials:

1, relevant medical graduates of college (including college) diploma product quality supervision and testing personnel (one of the quality testing responsible);

2, quality supervision and testing personnel ID card and a copy of the certificate of graduation, the work of the resume; (Food and Drug Administration teacher to come to the site to verify the interviews need to provide the relevant test) Personnel ID card and original diploma, and in person);

3, the sale of medical devices to the manufacturer of the other company's business license, medical device manufacturer's license;

4, the sale of medical devices to the manufacturer of the other medical device registration certificate, medical device registration form;

5, the sale of medical devices to the manufacturer of the other commissioned the sale of the power of attorney;

5, the sale of medical devices to the manufacturer;