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1. Apply for a medical device manufacturing license: the applicant needs to submit the materials to the State Food and Drug Administration, after the audit, if it meets the relevant requirements, the applicant will be issued a manufacturing license.
2. Apply for a medical device registration certificate: After having a medical device production license, the applicant needs to submit the application materials for medical device registration to the state food and drug regulatory authorities, and if passed the audit, the medical device registration certificate will be issued.
3. Apply for a medical device market license: After having a medical device registration certificate, the applicant needs to apply for a market license from the food and drug regulatory department of the district or city where the applicant is located, and if the applicant passes the audit, a market license will be issued.
4. Payment of relevant fees:After obtaining all kinds of licenses, the applicant needs to pay the relevant certificate fees and data certification fees to the relevant organizations.
5. Receive certificates:After paying the certificate fees, you can receive the medical device manufacturing license, medical device registration certificate and market license, and formally start the operation.
Medical device qualification conditions
1. the applicant must be a legal enterprise legal person, and have the qualification of operating medical devices;
2. medical devices must be clinically tested and certified by the relevant national departments and meet the requirements of safe, effective and stable use;
3. the applicant must have the appropriate financial and technical strength. Can ensure the quality of medical devices and after-sales service;
4. Need to provide relevant supporting materials, including medical device production license, quality management system certification, safety and effectiveness assessment report, medical device registration certificate, and so on.
I hope the above can help you, if you have other questions please consult a professional lawyer.
Legal basis: "Medical Device Business License" Article VI apply for "Medical Device Business License" should have the following conditions: (a) with the scale and scope of business with the quality of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized professional qualifications or titles; (B) with the scale and scope of operation of relatively independent business premises; (C) with the scale and scope of operation of storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of the medical device products; (D) should establish and improve the product quality management system, including purchasing, purchase (D) should establish and improve the product quality management system, including procurement, purchase and acceptance, storage and storage, out of the warehouse review, quality tracking system and adverse event reporting system; (E) should have its operation of medical equipment products with appropriate technical training and after-sales service capabilities, or agreed by the third party to provide technical support.