Regulatory Approval Process for Medical Devices in China

In order to market and sell medical devices in China, manufacturers are required to undergo a regulatory approval process governed by the China Food and Drug Administration (CFDA). This article provides a detailed overview of the steps involved in obtaining CFDA approval for medical devices, highlighting key requirements and considerations for manufacturers.

Step 1: Determining Device Classification and Clinical Data Requirements: 

The first step is to determine the classification of the medical device in accordance with CFDA's Order No. 15 and the CFDA's classification database. For Class II and III devices, manufacturers must identify predicates and ascertain the clinical data requirements and methods to fulfill them.

Step 2: Appointment of a Local Agent:

To facilitate CFDA device registrations, manufacturers need to appoint an authorized agent located in China. This agent will serve as a liaison and coordinate the regulatory processes on behalf of the manufacturer.

Step 3: Proof of Home Country Approval:

Manufacturers must demonstrate proof of approval or market authorization in their home country by providing a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG).

Step 4: Proof of Manufacturer's Qualification:

Manufacturers are required to submit a notarized "proof of qualification of the manufacturer." This can be satisfied through various means, such as possessing an ISO 13485 certificate, an Establishment Registration from the FDA (for US companies), or a Manufacturing License (for Japanese or Korean companies).

Step 5: Preparation of Technical Requirement Document:

A Technical Requirement document must be prepared, particularly for Class II and III devices. This document should include details of any additional testing that needs to be conducted in China.

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Step 6: Testing in CFDA-Authorized Laboratory

For Class II and III devices, manufacturers are required to send their devices to a CFDA-authorized laboratory in China for testing. Testing fees are to be paid by the manufacturer.

Step 7: China Clinical Evaluation

For Class II and III devices that are not exempted under a clinical trial list, manufacturers need to prepare a China Clinical Evaluation. This may require data from clinical trials conducted specifically for the Chinese market.

Step 8: Document Preparation and Submission

For Class I devices, manufacturers need to prepare technical documentation for submission to the CFDA. A Registration Dossier must be prepared and submitted for Class II and III devices, along with payment of applicable fees. The dossier should include various documents such as the Technical Requirement document, proof of qualification of the manufacturer, CFS/CFG, Agent authorization letter, test reports, China Clinical Evaluation (if required), and other relevant documents. All documents must be in Simplified Chinese.

Step 9: Application Review Process

Class I device submissions undergo an administrative review, while Class II and III submissions undergo a full application review that includes both technical and administrative assessments. Novel and high-risk products may also be subject to an Expert Panel Meeting. The CFDA may conduct an on-site Quality Management System (QMS) audit of the manufacturing facilities.

Step 10: Issuance of CFDA Certificates

Class I devices that pass CFDA review will receive a voucher, while Class II and III devices receive the Import Medical Device Registration Certificate (IMDRC) following a successful review. The IMDRC certificate is valid for five years, and the CFDA registration number must be displayed on the device labeling, including the Instructions for Use (IFU) or user manual.

Step 11: Approval to Sell

Upon obtaining CFDA approval, manufacturers are authorized to market and sell their medical devices in China.

Conclusion

Navigating the CFDA regulatory approval process for medical devices in China can be complex and time-consuming. Manufacturers must carefully adhere to the outlined steps, ensuring compliance with classification requirements, clinical data submissions, testing, and documentation. Additionally, the CFDA reserves the right to request further documentation and conduct audits, which may extend the approval timeline. Seeking expert guidance and staying informed about specific CFDA requirements are essential for a successful market entry into China's thriving medical device industry.

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