Medical Device Inspection Updates Q&A by NMPA for Class III Devices in China

Medical device inspection guidance from China’s National Medical Products Administration (NMPA) has been clarified through a recent official Q&A on production site compliance. The document provides detailed insights into product release procedures, quality management requirements, and system expectations—particularly for Class III devices. Overseas manufacturers can refer to this Q&A to better align with China’s regulatory standards.

Implications for International Manufacturers

Standardization of Product Release
According to Article 60 of the "Regulations on the Production Quality Management of Medical Devices," overseas manufacturing enterprises must ensure that product release meets the following requirements:
1. The inspection items and methods for outgoing products should be carried out in accordance with the company's own finished product inspection procedures, and in principle, should cover the inspection items and methods that need to be routinely controlled in the product technical requirements. If not fully covered, an explanation and alternative solutions should be provided in the finished product inspection procedures.
2. The Chinese labels and instructions for use must comply with the "Regulations on the Management of Instructions and Labels for Medical Devices."
Standardization of Computer Information Systems for Class III Medical Device Business Operations
As a Class III medical device manufacturing enterprise (which is both a producer and a business operator of its own Class III medical devices), the official Q&A requires that a computer information system meeting the requirements for the quality management of medical device operations must be equipped, and the provisions related to computer information systems in the "Regulations on the Quality Management of Medical Device Operations" must be followed.The newly revised "Regulations on the Quality Management of Medical Device Operations," which came into effect on July 1, 2024, has detailed requirements for the functions of computer information systems. For example, it must have the capability to conduct real-time quality control over various operational links such as purchasing, receiving, acceptance, storage, sales, dispatch, review, and returns; have permission management functions to ensure that data entry, modification, and storage operations comply with the authorized scope, etc.; and have the functions of quality traceability in the operation process and collection and recording of unique identifiers for medical devices.

Key Changes Comparison

More Refined Regulatory Requirements:
Compared to the past, current regulatory requirements focus more on details and operability. Previously, regulations on product release and inspection items might have been relatively vague, but now, through official Q&A and other forms, these specific issues have been clarified and detailed. This provides companies with clearer guidance for implementing regulations, reducing ambiguity in understanding and operation.
Enhanced Corporate Primary Responsibility:
New regulations and Q&A place greater emphasis on the role of medical device manufacturers as the primary responsible parties for product quality. Companies are required to take on more responsibilities and obligations in quality management systems, supplier management, product traceability, and other aspects.
Emphasis on Information Management:
The use of information technology enables real-time monitoring and data traceability in the operation of medical devices, improving regulatory efficiency and precision. It also prompts companies to enhance their own information management levels.

Impact on International Customers and Recommendations

Regulatory Research and Compliance:
Overseas manufacturers should strengthen regulatory research and compliance management, optimize their quality control systems, and enhance communication with regulatory authorities.
Communication with Authorities:
During key stages such as product registration, production site changes, and contract manufacturing, companies should promptly communicate with regulatory authorities to understand regulatory requirements and seek guidance and support.
Adaptation to Local Environment:
Through good communication with regulatory authorities, companies can better adapt to the regulatory environment in China.

Further Information

To read the original official Q&A on medical device production site inspection requirements released by China’s National Medical Products Administration (NMPA), please refer to the first part of the Q&A addressing key production site compliance requirements and the follow-up clarification covering Class III device information system standards.

If you are a medical device manufacturer with questions about how China’s new inspection and quality system requirements affect your operations or registration pathway, please contact Cisema.