1. Business license, which needs to specify the scope of business.
2. warehouse, need to set up cold storage.
3. sales qualification, need to submit the relevant qualifications.
4. medical device business license, need to go directly to the municipal drug supervision and management department.
Application conditions and process
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 the column, need to be clearly written 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 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 business bureau for the addition, it is necessary to bring the business 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, but also need to bring the quality of the staff's relevant information.
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) The registered capital is 10,000 yuan or more.
I hope the above can help you, if there are still questions please consult a professional lawyer.
Legal basis:
"Supervision and Administration of Medical Devices Regulations" Article 29
Engaged in medical device business activities, there should be with the scale and scope of operation of the business premises and storage conditions, as well as with the operation of medical devices and quality management system and quality management organizations or personnel.
Article 30
Engaged in the second class of medical equipment business, by the business enterprise to the municipal people's government of the location of the municipal food and drug supervision and management department for the record and submit it to comply with the conditions of the provisions of Article 29 of these Regulations.
Article 31
Engaged in the third class of medical equipment business, the business enterprise shall be located in the municipal people's government of the food and drug supervision and management department to apply for a license to operate and submit the conditions of its compliance with the provisions of Article 29 of these Regulations. Acceptance of applications for business license food and drug supervision and management department shall be accepted within 30 working days from the date of review, if necessary, the organization verification. To meet the prescribed conditions, permit and issue a medical device license; do not meet the prescribed conditions, not permit and explain the reasons in writing. Medical device license is valid for 5 years. The expiration of the validity of the need for continuation, in accordance with the provisions of the relevant administrative licensing law for continuation procedures.