For NMPA (National Medical Products Administration) registration of medical devices in China, compliance with specific standards and regulations is crucial to ensure safety, efficacy, and quality. Here are some key standards and regulatory requirements that typically apply:

General Standards and Guidelines:

1. Good Manufacturing Practice (GMP):

   • Compliance with Good Manufacturing Practice regulations ensures that medical devices are consistently produced and controlled to meet quality standards. This includes facilities, equipment, personnel, and processes.

2. Quality Management System (QMS):

   • ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes. Certification to ISO 13485 or an equivalent standard demonstrates conformity to quality management system requirements specific to medical devices.

Specific Technical Standards:

1. Performance and Safety Standards:

   • IEC 60601 Series: Standards for safety and essential performance of medical electrical equipment, covering aspects such as electrical safety, electromagnetic compatibility (EMC), and usability.
   • ISO 14971: Application of risk management to medical devices. Compliance with ISO 14971 involves identifying hazards associated with medical devices and managing risks throughout the lifecycle.

2. Biocompatibility Standards:

   • ISO 10993 Series: Biological evaluation of medical devices. Compliance with ISO 10993 involves assessing the biological safety of the device, including testing for cytotoxicity, sensitization, and irritation.

3. Labeling and Packaging Standards:

   • GB/T 15490: General requirements for medical device labels and instructions for use. These standards ensure that labeling provides clear information on device identification, usage instructions, warnings, and precautions in Chinese.

Clinical Standards and Requirements:

1. Clinical Evaluation and Trials:
   • Depending on the device classification and risk level, clinical evaluation and trials may be required. Compliance involves conducting clinical studies according to NMPA guidelines and ethical standards, including reporting of adverse events.

Submission and Documentation Requirements:

1. Technical Documentation:

   • Comprehensive documentation demonstrating device safety, efficacy, and quality. This includes device descriptions, technical specifications, design rationale, testing reports, risk management documentation, and manufacturing information.

2. Application Process:

   • Submission of applications and supporting documentation through the NMPA's designated online platform or authorized third-party service providers. Applications must be complete, accurate, and comply with current regulatory requirements.

Regulatory Updates and Compliance:

1. Regulatory Updates:
   • Stay informed about changes in NMPA regulations, guidelines, and standards. Regularly review updates to ensure ongoing compliance throughout the device lifecycle.

Expert Assistance:

• Consult with Regulatory Experts: Engage with regulatory consultants or local agents experienced in NMPA registration processes. They can provide guidance on navigating standards, compiling required documentation, and ensuring compliance with regulatory requirements.

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