Yes, providing enterprise background information is generally necessary for NMPA certification of medical devices in China. This information helps demonstrate the credibility, capabilities, and compliance of the manufacturer or the applicant. Typically, the enterprise background information includes details such as:

1. Company Overview: Description of the company, its history, structure, and management.

2. Quality Management System: Information about the quality management system in place, such as ISO 13485 certification.

3. Manufacturing Facilities: Details about the manufacturing facilities where the medical devices are produced, including their location and capabilities.

4. Regulatory Compliance: Previous regulatory approvals or certifications obtained for similar products in other markets.

5. Product Portfolio: Information about the range of medical devices manufactured by the company.

6. Financial Standing: Sometimes, financial information to demonstrate stability and capability to support production and quality assurance.

7. Authorized Representative: If applicable, details about the authorized representative in China, responsible for regulatory affairs.

Including comprehensive enterprise background information helps NMPA assessors evaluate the manufacturer's ability to consistently produce safe and effective medical devices that meet regulatory requirements.

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