The cost and timeline for Class II Medical Device NMPA registration in China can vary based on several factors, including the complexity of the device, the completeness of documentation, the need for clinical data, and regulatory updates. Here’s a general overview:

Cost:

1. Consultancy Fees: Engaging regulatory consultants or legal experts familiar with Chinese medical device regulations can incur significant costs. Fees can vary widely based on the scope of services required, such as document preparation, regulatory strategy, and liaison with NMPA.

2. Testing and Certification: Costs associated with conducting required tests according to Chinese standards or international standards recognized by NMPA can vary depending on the type of tests needed and the testing laboratory chosen.

3. Local Agent Fees: The local agent in China typically charges fees for their services, including acting as the official representative throughout the registration process and maintaining compliance with ongoing regulatory obligations.

4. Miscellaneous Costs: These may include translation of documents into Chinese, fees for document submissions through the NMPA's online platform, and potential costs related to an onsite inspection if required.

Timeline:

1. Preparation Phase: The preparation of technical documentation, including clinical data (if applicable), can take several months. This phase depends on the completeness of initial documentation and the complexity of the device.

2. Submission and Review: Once the application is submitted through the China Medical Device Registration (CMDR) system, the initial review by NMPA can take several months. This period includes the evaluation of technical files, test reports, and compliance with regulatory requirements.

3. Onsite Inspection (if required): If an onsite inspection of manufacturing facilities is necessary, it can add several months to the timeline, depending on scheduling and inspection logistics.

4. Approval and Certification: Upon successful review and potential inspection, NMPA typically issues a registration certificate. The timing for this final approval can vary but may take several months from initial submission to certificate issuance.

Overall Timeline Estimate:

• Total Processing Time: Generally, the entire process from preparation to obtaining the registration certificate for a Class II Medical Device in China can range from 12 months to 18 months or more, depending on various factors.

• Expedited Processes: Expedited pathways may be available for certain devices or under special circumstances, potentially shortening the timeline. However, these pathways often come with additional costs or requirements.

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