NMPA (National Medical Products Administration) certification is essential for medical devices to be marketed in China. Here’s an overview of the scope and applicable regulations for NMPA certification:

1. Scope of NMPA Certification

NMPA certification applies to a broad range of medical devices, including:

• Class I Devices: These are low-risk devices subject to the least regulatory control. Examples include simple diagnostic devices and certain surgical instruments.
• Class II Devices: These are moderate-risk devices requiring more regulatory control. Examples include infusion pumps and some diagnostic equipment.
• Class III Devices: These are high-risk devices requiring the most stringent regulatory control. Examples include heart valves and pacemakers.

2. Regulatory Framework

Key Regulations and Guidelines

1. Medical Device Supervision and Administration Regulation (MDSAR): This regulation governs the management of medical devices, outlining the requirements for registration, manufacturing, and post-market surveillance.

2. Regulations on the Supervision and Administration of Medical Devices: This detailed regulation includes requirements for registration, production, and importation of medical devices.

3. Technical Guidelines for Registration of Medical Devices: These guidelines provide specific technical requirements for the registration of different types of medical devices.

4. Good Manufacturing Practice (GMP) for Medical Devices: This guideline specifies the quality management standards that manufacturers must adhere to.

5. Regulations on the Supervision and Administration of Medical Device Clinical Trials: These regulations govern the conduct of clinical trials necessary for the approval of medical devices.

3. Certification Process

Pre-Submission

• Prepare Documentation: Gather all required documentation, including technical files, clinical data, and manufacturing information.
• Determine Classification: Verify the classification of your device (Class I, II, or III) as it will dictate the regulatory pathway.

Submission

• Submit Application: Submit the application along with required documentation to the NMPA. For Class I devices, the process is typically simpler and involves fewer documents. For Class II and III devices, more comprehensive documentation is required.
• Review Process: NMPA conducts a technical review of the application. This includes assessing the safety and effectiveness of the device based on submitted data.

Approval

• Certification Issuance: Upon successful review, NMPA issues a registration certificate allowing the device to be marketed in China.
• Post-Market Surveillance: Once certified, the device is subject to post-market surveillance requirements, including periodic inspections and reporting of adverse events.

4. Requirements and Considerations

• Clinical Trials: For Class II and III devices, clinical trials in China might be required. The trials must adhere to local guidelines and standards.
• GMP Certification: Manufacturers must comply with GMP standards, and facilities may need to be inspected and certified by NMPA.
• Language Requirements: All documentation must be provided in Chinese or accompanied by a certified translation.
• Importation: For foreign manufacturers, a local representative in China may be required to handle regulatory matters and post-market responsibilities.

5. Timelines and Costs

• Timelines: The registration process can take several months to over a year, depending on the class of the device and the complexity of the submission.
• Costs: Costs include application fees, clinical trial expenses (if applicable), and fees for translation and notarization of documents.

6. Recent Updates

NMPA continually updates its regulations to align with international standards and improve the efficiency of the certification process. Keeping abreast of these changes is crucial for compliance.

Useful Links

For more detailed information, you can visit the NMPA’s official website:

• NMPA Official Website

If you have specific questions or need assistance with the application process, consulting with a regulatory expert familiar with NMPA regulations can be highly beneficial.

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