Medical equipment business license is a medical device business enterprises must have the documents, the opening of the second class of medical equipment business enterprises, should be to the provinces, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department for the record; the opening of the third class of medical equipment business enterprises, should be by the provinces, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department for examination and approval.
Medical equipment business license process is as follows:
1, the applicant shall have qualified legal personality or other forms of organization, and registered in the administrative department for industry and commerce;
2, to prepare the relevant application materials, including medical device license application form, the applicant's identity card, organization code certificate, tax registration certificate, business license, enterprise production license, medical device license application form, the applicant's identification, organization code certificate, tax registration certificate, business license, enterprise production license, medical device license application form. Business license, enterprise production license, medical device product registration certificate, etc.;
3, submit application materials, the applicant should submit a written application to the local food and drug supervision and management department and submit the application materials described above;
4, the regulatory authorities on-site verification, to verify the authenticity of the applicant's submitted application materials. If the submitted materials do not meet the requirements, the regulatory department will require the applicant to make additional submissions;
5, on-site inspection, the regulatory department will carry out on-site inspections to check whether the applicant's premises, equipment, personnel, storage, quality management and other aspects of compliance with the relevant regulatory requirements;
6, audit and evaluation, the regulatory department will be the applicant to submit the materials and the results of the on-site inspection review, the applicant meets the requirements of the
7, the issuance of medical device license, through the audit of the applicant will be issued a medical device license, obtaining the qualification of legal operation of medical devices.
In summary, the Medical Device Business License is now a post approval, which is applied for after the business license is issued by the Administration for Industry and Commerce. The Medical Device Business License is valid for 5 years.
Legal basis:
"Supervision and Administration of Medical Devices 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 municipal people's food and drug supervision and management department to apply for a license to operate and submit its compliance with the conditions set out in Article 29 of the Regulations of the proof of information.
Acceptance of applications for business license food and drug supervision and management departments should 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.