The NMPA (National Medical Products Administration) is responsible for regulating and supervising medical devices in China. The NMPA performs inspections to ensure that medical device manufacturers comply with the regulatory requirements and safety standards in China and to verify that medical devices are safety andeffectiveness, and that they meet the requirements for registration, production, distribution, and use in China.
During inspections, NMPA inspectors may review manufacturing processes, quality control systems, technical and regulatory documentation, and other medical device production and distribution aspects. Inspections can also include site visits, interviews with personnel, and reviews of documents and records.
In this series of blogs, we will discuss several types of inspections that the NMPA may conduct:
1. Pre-licensing inspection: This inspection is conducted before the NMPA issues a product certificate and manufacturing permit to a manufacturer to sell their medical devices in China. The inspection verifies that the manufacturer's facilities, test validation. Document control and manufacturing processes comply with the relevant Chinese regulations and standards.
Announcement No. 50 of 2022 issued by the NMPA of China provides guidelines for the verification of the quality management system (QMS) for medical device registration with astrong focus on the design and development transfer, testing validation, product realization, clinical trials handling, and control of outsourced processes during the device development phase. In addition, local manufacturers will be audited against Chinese GMP(No. 64) to issue the manufacturing permit. Foreign manufacturers could provide their QMS files under ISO13485.
2. Routine inspection: After a foreign manufacturer is licensed to sell their medical devices in China, routine inspections may be conducted periodically to ensure ongoing compliance with Chinese regulations and standards. This is called overseas inspection, which is similar to FDA random audit.
In accordance with Provisions for Supervision and Administration of Medical Device Manufacturing (Promulgated by Decree No. 53 of the State Administration for Market Regulation on March 10, 2022, these Provisions are effective as of May 1, 2022.) to engage in manufacturing activities of medical devices, an entity shall comply with laws, regulations, provisions, mandatory standards and the Good Manufacturing Practice for medical devices, and guarantee that information on the whole medical device manufacturing process is authentic, accurate, complete and traceable.
Specific considerations regarding the implantable, sterile medical devices, independent software, custom dentures, and in-vitro diagnostic reagents shall be considered.
3. For-cause inspection: For-cause inspections are conducted by the NMPA to investigate suspected violations of Chinese regulations and standards for medical devices, and to ensure that medical devices sold in China are safe and effective. For-cause inspections can be triggered by a variety of factors, including complaints from patients or healthcare providers, adverse event reports, information obtained from inspections of manufacturers or distributors, or if there is any other reason to suspect that a device may be unsafe or non-compliant.
In recent years, the NMPA has significantly increased its regulatory oversight of medical devices, including conducting more frequent inspections of manufacturers and distributors due to a number of factors such as:
- The rapid growth of the medical device industry in China has led to an increase in the number and variety of medical devices available on the market. This has created a need for more stringent regulation to ensure that these devices are safe and effective for patients.
- There have been a number of high-profile incidents involving medical devices in China. These incidents have led to increased public concern about the safety and efficacy of medical devices and have put pressure on the government to take more action to regulate the industry.
4. Post-market surveillance inspection: These inspections are conducted to verify the safety and effectiveness of medical devices that are already on the market in China. They are aimed at detecting any issues or risks that may have been missed during the initial licensing or routine inspections.
Announcement No. 101 of 2018, Regulations for the Administration of Overseas Medical Device Inspections provides regulation on the NMPA's inspection process for companies located outside of China, for which an on-site inspection is necessary in the pre-market or post-market phase.
The regulations also require that Chinese regulatory authorities have the right to conduct on-site inspections of overseas manufacturing facilities to ensure compliance with Chinese regulations. Failure to comply with these regulations may result in penalties or even a ban on importing products into China.
The Announcement No. 101 of 2018 reflects the Chinese government's commitment to improving the safety and efficacy of drugs and medical devices sold in the country, as well as its determination to enforce strict regulatory standards. The inspection scope is also against China GMP. No.101 is a guidance document to detail the inspection process.
In addition to medical device manufacturers, the NMPA inspects distributors of medical devices in China. Article 42 of State Council Order No. 739, Regulations on the Supervision and Administration of Medical Devices provides that medical device distributors are required to obtain a medical device distribution license from the NMPA before they can legally distribute medical devices in China. The NMPA conducts inspections of these distributors to ensure that they comply with Chinese regulations and standards for medical devices.
During the inspection, the NMPA may examine the distributor's QMS, storage and transportation conditions, sales and marketing practices, and other aspects of their operations. If the NMPA finds that the distributor is not complying with regulations, it may issue warnings, fines, or even revoke their distribution license. China GSP (NMPA Order No.54) is applicable here.
Foreign manufacturers of medical devices should be prepared for these different types of NMPA inspections and ensure that they comply with the relevant regulations and standards. A proactive approach to check its compliance and quality management internally can help to minimize the risk of non-compliance and improve the chances of passing NMPA inspections. Passing NMPA inspections is essential for medical device manufacturers who want to sell and keep their products in the Chinese market as well as distributors who operates the devices on the market.
Becoming curious about what the NMPA inspection process entails?
Read our blog series - 7 parts:
Part 1. China NMPA inspection types
Part 2. China NMPA inspection process
Part 3. Preparation for China NMPA inspection
Part 4. Verification of the QMS for Medical Device Registration
Part 5. Verification of the QMS for Medical Device Production
Part 6. Verification of the QMS for Medical Device Distribution
Part 7. China NMPA Inspection Results and Common Findings
If you need assistance with the preparation to upcoming NMPA inspection, mock-inspection, gap assessment of QMS compliance with China regulations, or need subject-matter expertise contact us.