Enterprises engaged in the wholesale business of Class II and Class III medical devices, sales records should also include the name of the purchaser, address, contact information, the relevant license document number or record number.
Application conditions and procedures
1, to apply for the three types of medical equipment business license, there must be a relevant business license, the general business license on the business scope of this column, need to be clearly written to the sale of 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 and affect the quality of the product, so very few dealers have the qualifications of the sale of Class III medical devices.
3, go to the industrial and commercial bureau for the addition, it is necessary to bring the industrial and commercial bureau staff to view the warehouse, you'd 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 with, but also need to bring the quality of the relevant information of the personnel.
4, three types of medical equipment business license, you need to go directly to the municipal drug supervision and management department for, in 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.
CIO Compliance Assurance Organization (CIO) provides medical device business license processing business and counsels enterprises to pass the on-site inspection at one time and get the license successfully.
How to apply for a license to operate a medical institution
Object of application: enterprises, institutions, social organizations and other institutions and individuals applying to open a medical institution.
Two for each medical (individual) medical institution license conditions:
(1) in line with the Autonomous Prefecture "medical institutions set up planning".
(2) in line with the Ministry of Health "basic standards for medical institutions.
(3) Having local household registration.
(4) The floor area of the house reaches 40 square meters or more.
(5) Obtaining a state-recognized secondary school education or above.
(6) Obtain the title of physician in the province and district, and engage in clinical staff of the same specialty in the registered medical institution for more than five years.
(7) Health technicians with titles outside the region must obtain a Physician's Practice Certificate before applying for a Medical Institution Practice License.
(8) Currently engaged in clinical activities must be the same as the physician title specialty (single subject).
(9) Registered capital of 10,000 yuan or more.