The scope of application and compliance requirements for NMPA (National Medical Products Administration) certification of medical devices in China involve several key aspects, including product classification, documentation, testing, and regulatory processes. Here’s a detailed overview:
1. Scope of Application
NMPA certification applies to all medical devices that are intended for use in diagnosing, treating, or preventing diseases, or for other medical purposes. The scope covers:
- Class I Medical Devices: Low risk, including items such as bandages or simple surgical instruments.
- Class II Medical Devices: Moderate risk, such as infusion pumps and diagnostic imaging devices.
- Class III Medical Devices: High risk, including complex devices like pacemakers and implantable prosthetics.
2. Compliance Requirements
a. Product Classification
Medical devices in China are classified into three categories based on risk:
- Class I: Devices that have a low risk and are subject to basic controls.
- Class II: Devices that have a moderate risk and require more controls to ensure safety and effectiveness.
- Class III: Devices that present a high risk and require rigorous controls and pre-market approval.
b. Documentation and Registration
Product Technical Requirements: Submit detailed technical documentation, including specifications, design, manufacturing process, and labeling.
Clinical Evaluation: For Class II and III devices, clinical data may be required to demonstrate safety and efficacy. Clinical trials conducted outside China may need to be re-evaluated or supplemented with local data.
Quality Management System (QMS): Compliance with QMS standards such as ISO 13485 is required. The manufacturer’s QMS should be documented and demonstrate adherence to quality standards.
Product Testing: Medical devices must undergo testing to ensure they meet Chinese standards. Testing is conducted by certified laboratories, and reports need to be submitted with the application.
Manufacturer’s Credentials: Documentation verifying the manufacturer’s capabilities and history, including business licenses, company profiles, and manufacturing processes.
Labeling and Instructions: Labels and instructions must be in Chinese and comply with NMPA requirements. This includes proper use, warnings, and contraindications.
c. Regulatory Process
Pre-Market Application: Submit an application to NMPA, including all necessary documentation, test reports, and clinical data. This includes forms such as the Registration Application Form for Medical Devices.
Review and Approval: NMPA will review the application and may request additional information or clarification. For Class III devices, the review process is more extensive and may involve onsite inspections.
Certification Issuance: Upon successful review, NMPA will issue a Medical Device Registration Certificate. This certificate is valid for 5 years.
Post-Market Surveillance: Once certified, manufacturers must comply with post-market surveillance requirements, including reporting adverse events and conducting regular audits.
Renewal and Changes: Certification must be renewed before expiration. Any changes to the product, manufacturing process, or labeling must be reported to NMPA and may require additional review.
d. Compliance and Enforcement
Inspections: NMPA may conduct inspections of manufacturing facilities to ensure ongoing compliance with regulatory requirements.
Adverse Event Reporting: Manufacturers must report any adverse events or product defects to NMPA and take corrective actions as necessary.
Market Surveillance: NMPA monitors the market for compliance and can take enforcement actions such as recalls or fines for non-compliance.
Resources
For detailed and updated information, refer to the official NMPA website and related regulatory guidance:
This comprehensive approach ensures that medical devices meet safety and efficacy standards required for the Chinese market.
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