Yes, China NMPA (National Medical Products Administration) certification for medical devices does require import documents, particularly for foreign manufacturers seeking to sell their medical devices in the Chinese market. These documents are crucial for ensuring that the product complies with Chinese regulations and standards before it can be marketed and distributed in China. Below are the key import documents required during the NMPA certification process:

1. Importer’s Authorization

• Importer License: Foreign manufacturers must designate a Chinese local agent or importer, as NMPA registration is generally only available for companies with a presence in China. This local representative or importer must have a valid business license and the authority to handle medical device registration in China.
• Power of Attorney (PoA): The foreign manufacturer must provide a power of attorney authorizing the local Chinese agent or importer to act on their behalf during the NMPA certification process. This document must be notarized and submitted along with the application.

2. Business License of the Importer

• A valid business license of the local importer in China must be submitted. This verifies that the entity is legally authorized to import and distribute medical devices in China.
• The business license should indicate the company’s registered activities related to the medical device industry (importing, distribution, etc.).

3. Import Registration Certificate

• Foreign manufacturers must ensure that their import registration certificate (if applicable) is in place. The importer or local representative in China is responsible for obtaining this document. It confirms that the importer is authorized to handle medical device imports.

4. Product Labeling and Instructions for Use (IFU) in Chinese

• NMPA requires all medical devices imported into China to have Chinese-language labeling and Instructions for Use (IFU). These must include:
  • Product name.
  • Manufacturer’s information.
  • Usage instructions.
  • Safety warnings and contraindications.
• The Chinese labels and IFUs must comply with NMPA regulations and be reviewed as part of the certification process.

5. Import Customs Documents

• Customs Declaration: When the product enters China, the importer must file a customs declaration with Chinese customs authorities. The customs declaration should include detailed information about the product, including the Harmonized System (HS) code, which classifies the product for tariff purposes.
• Import Customs Clearance: The import documents and customs clearance process ensure that the medical devices meet Chinese safety standards before they are sold to the market.

6. NMPA Registration Documents

• Device Registration Application: This is the primary document required to initiate the NMPA certification process. It includes detailed information about the device, such as:
  • Device classification (Class I, II, or III).
  • Product description and intended use.
  • Risk analysis and safety data.
  • Manufacturing details (quality control system, manufacturing practices, etc.).
• Clinical Trial Data (if required): For Class II and III devices, clinical trial data may be required. The local agent/importer will need to manage the clinical trials, which may need to be conducted in China or meet Chinese standards.

7. Quality Management System Certification (ISO 13485)

• Foreign manufacturers must provide ISO 13485 certification or other recognized quality management system certifications. This demonstrates that the manufacturer adheres to internationally recognized standards for medical device manufacturing.
• The ISO 13485 certificate and relevant documents need to be submitted as part of the NMPA application process. The local importer must confirm that the manufacturer complies with these standards.

8. Import and Sales Agreement

• Import Agreement: The foreign manufacturer and Chinese importer must have a signed agreement that outlines the terms and responsibilities for importing and distributing the medical device in China. This document is typically required by NMPA to confirm the business relationship.
• Sales Agreement: This agreement may also be requested if the importer is planning to distribute the device within China. It will show the arrangements for how the product will be marketed and sold.

9. Product Samples

• In some cases, product samples may be required for testing during the NMPA registration process. These samples are typically used for clinical evaluations, safety testing, or performance testing.

10. Foreign Manufacturer’s Certification (if applicable)

• Depending on the device and the specific requirements, the NMPA may require certifications from the foreign manufacturer or other countries to demonstrate that the device has been previously approved in other regulatory jurisdictions (e.g., CE mark, FDA approval, etc.).

11. Importation Record for Class II/III Devices

• For Class II and Class III medical devices, additional documents such as importation records may be needed, which could include evidence of the device's prior approval in foreign markets or any special testing reports.

Key Steps in the Import Process:

1. Selection of a Local Importer: A foreign manufacturer must select an authorized Chinese importer or agent with the required credentials to handle NMPA registration and importation processes.
2. Preparation of Documents: Both the manufacturer and importer must prepare the required documents, including the power of attorney, business licenses, product data, and quality certifications.
3. Customs Clearance: The importer must ensure that all customs documentation is completed for importing the device into China.
4. Submission of NMPA Application: The local representative submits the NMPA registration application and all required documents for the safety review and approval process.
5. Approval and Importation: After NMPA approval, the device can be legally imported and marketed in China, subject to customs clearance.

Conclusion:

China's NMPA certification process does require various import documents to facilitate the legal importation of foreign medical devices. These documents help ensure compliance with Chinese regulations, covering everything from importation rights to product safety and quality. The local Chinese agent or importer plays a central role in managing these documents and liaising with NMPA and customs authorities to ensure the medical device can be legally marketed in China.