1, with the qualification requirements: the applicant must be established in accordance with the law and has an independent legal personality of enterprises and institutions, or in accordance with the law in the administrative region and obtain the registration of business license for individual business households.
2, prepare the application materials: the applicant needs to prepare the relevant application materials, including the business license of the enterprise legal person, medical device business enterprise license, medical device quality management standard certification.
3, online application: the applicant needs to log in the State Drug Administration medical device license online application system, fill in the relevant information and upload application materials.
4, on-site audit: the applicant submits the application, the relevant departments will be the applicant's premises, quality management system, business scope of the on-site audit.
5, the audit results: after the audit, the applicant needs to pay the appropriate fees and receive the second-class medical device business license. If the audit is not passed, the applicant can reapply within the specified time, or apply for reconsideration.
The information required for the application of Class II medical device license is as follows:
1, application form: fill in the application form for Class II medical device license;
2, business license: provide a copy of the company's business license;
3, legal representative identification: provide the legal representative's identification documents, such as identity cards, passports, etc.;
4, proof of business premises: provide proof of business premises, such as property rights certificates, lease contracts and other supporting materials;
5, proof of corporate qualifications: provide proof of corporate qualifications, such as medical device quality management system certification;
6, proof of employees: provide proof of qualifications and training of employees and other related materials;
7, quality control manual: provide Quality control manual and other quality management documents.
In summary, the applicant should comply with the relevant laws and regulations when applying to ensure that the application materials are true and effective, and the establishment of the business premises in line with the requirements of the regulations.
Legal basis:
"People's Republic of China*** and the State Medical Device Supervision and Administration Regulations" Article 31
To engage in the operation of Class III medical devices, the business enterprise shall be located in the municipal people's government of the municipal government of the application for permission to operate and submit the conditions of its conformity with the provisions of Article 29 of the Regulations of the supporting 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.