Need to go to the Industrial and Commercial Bureau for Class 2 medical device business record, need to have a business address of not less than 60 square meters, the need for hearing professional equipment, medical, electronics and other professional degree graduates to act as the person in charge of the quality of the on-site verification of the qualified license issued after the business.
Individual businessmen can apply for a class 2 medical device license:
1, registered physician
2, need to cost listening to the test plus the certificate or less than 1000 yuan
3, the county drug supervision department is responsible for
First to the industrial and commercial verification of the name, approval to the local drug supervision to the status of a legal person apply for a license to operate; and then you can handle at the same time.
For the 2 level of business license, it is recommended that they go through the process, nothing difficult. There are several elements: to have and business type appropriate warehouse (very important, the warehouse should be divided into qualified area, unqualified area, to be inspected area and other signs, buy a few bamboo rafts, fire extinguishers, thermohygrometers, mouse traps, ledgers); enterprises to appoint a quality person in charge, and the person in charge of the academic qualifications of more than a college and have a relationship with the medical treatment; there is a corresponding management system; collection of relevant laws and regulations; to have to be prepared to operate The type of three certificates; the legal person and the person in charge of the enterprise should be familiar with Decree No. 276, etc..
Manufacturers need to provide the "Medical Device Manufacturing License", "Certificate of Conformity", the manufacturer's business license, it is best to have the manufacturer to the Drug Administration to provide the "Medical Device Registration Certificate" and authorization.