Drugdu.com expert's response:

Application Process for Quality Management System Verification of Class III Medical Device Registration within China

I. Submission of Registration Application and Verification Materials:

The applicant must submit a quality management system verification application simultaneously with the Class III medical device registration application to the National Medical Products Administration (NMPA). Within 10 days of accepting the registration application, the NMPA will notify the corresponding provincial, autonomous regional, or municipal drug regulatory authority (provincial authority) to initiate the verification.

II. Verification Notification and Material Preparation:

Within 10 working days of accepting the application, the NMPA's Center for Medical Device Evaluation (CMDE) will send the quality management system verification notification, relevant materials, and an electronic copy of the registration application form to the provincial authority. For cases involving cross-provincial contract manufacturing, the notification will only be sent to the provincial authority where the registrant is located, which shall then coordinate with the provincial authority where the contracted manufacturer is located to jointly conduct or delegate the on-site inspection.

III. Provincial Authority Conducts Verification:

The provincial authority shall conduct the quality management system verification in accordance with the Medical Device Production Quality Management Practices and its relevant appendices, as well as verification guidelines. The verification covers design and development, procurement, production management, quality control, and other aspects, with a focus on verifying the authenticity of samples used for registration testing and clinical trials. The verification period is generally 30 working days and may be extended if necessary.

IV. On-Site Inspection and Conclusion Issuance:

Prior to conducting the on-site inspection, the inspection team shall develop an inspection plan specifying the inspection content, schedule, and personnel assignments. The on-site inspection operates under the leadership of the inspection team leader, who is responsible for the overall process. The inspection team shall issue a recommended conclusion, categorized as "Pass Inspection," "Rectification Required for Re-inspection," or "Fail Inspection." The provincial authority shall review the materials submitted by the inspection team and issue a final verification conclusion.

V. Rectification and Re-inspection:

If the verification conclusion is "Rectification Required for Re-inspection," the applicant must submit a re-inspection application and a rectification report within six months in a single submission. The provincial authority shall complete the re-inspection within 30 working days of receiving the re-inspection application. If verification can be confirmed through documentation review, an on-site re-inspection may be waived. Failure to submit within the specified timeframe or continued non-compliance after rectification will result in a verification conclusion of "Fail After Rectification."

VI. Verification Result Feedback and Registration Decision:

Within 5 working days of issuing the verification conclusion, the provincial authority shall notify the NMPA's CMDE of the result. If the verification fails, the technical evaluation agency shall issue a recommendation for registration denial, and the NMPA shall make a decision to deny registration.