Medical Device Registration: This article is all you need

Registration inspection is the first major step in evaluating products before they are put on the market, and it plays an important role in registration review and post-market supervision. With the rapid development of the medical device industry, compared to the pharmaceutical management system, the registration inspection and inspection institutions of medical devices are still slightly inadequate. Strengthening the supervision of medical devices, improving the quality standards and management systems, and ensuring the safety and effectiveness of medical device use are particularly important.

I. Current Status of Medical Device Registration Inspection

Medical device registration inspection is a full-performance test of the product, also known as type testing. Class II and Class III medical devices undergo registration inspection by medical testing institutions accredited by the State Administration (Class I medical device approval procedures are assigned to local drug regulatory authorities; various cities and prefectures implement different management methods according to the actual use of the products; some products can be exempted from registration inspection, and some products require inspection[1] ), verifying through test data or conclusions that the tested product is safe and effective. Only after confirming that the tested product has passed the inspection can clinical trials or registration applications be carried out.

1. Registration Inspection Process

The drug registration inspection process includes: acceptance of drug registration applications, documentation and on-site inspections, drug registration inspection (including sample inspection and drug standard review), review, and approval. Generally, drug registration inspections are undertaken by the China Inspection Center or the drug inspection institutes of various provinces (municipalities and autonomous regions); registration inspections of imported drugs are organized and implemented by the China Inspection Center; registration inspections of special drugs and vaccines are undertaken by the China Inspection Center or drug inspection institutes designated by the State Food and Drug Administration.

The medical device registration inspection process mainly includes: registration inspection application, application acceptance, review and approval. Whether it is domestic or imported medical devices, sample testing is conducted at qualified medical device testing institutions; therefore, device registration inspection is relatively simple.

2. Source of Samples for Registration Inspection

According to the "Medical Device Registration Management Measures", "The production of registration inspection samples should meet the relevant requirements of the medical device quality management system, and only after passing the registration inspection can clinical trials or registration applications be carried out [2]". For medical device registration inspection products, whether imported or domestically produced medical device products, samples are submitted by the enterprises, and the management departments in the region do not participate in the registration inspection of medical device products. For example, for active medical devices, when applying for medical device registration inspection, enterprises can prepare materials and samples according to the inspection requirements of the medical device testing institution and arrange the inspection themselves, rather than having the management department in the region collect samples on-site (for drugs, registration inspection is carried out by the drug supervision and management department after on-site inspection).

Therefore, for medical device registration inspection products, especially products undergoing registration inspection for the first time, since the samples are not obtained through random sampling, the detected data are difficult to represent the quality of all products, making it difficult to guarantee the uniformity of the quality of all products, which will bring potential risks to the safety of device use.

3. Registration Inspection Items

In addition to testing according to national standards, industry standards, or standards formulated by the manufacturing enterprise itself, medical device products must also be tested according to national regulations or announcement documents for different types of medical devices.

Under normal circumstances, products that directly contact the human body (such as sterile products) must complete a biocompatibility evaluation; biocompatibility evaluation is generally not specified in product technical requirements. The manufacturing enterprise can provide the biocompatibility evaluation plan to the medical device testing institution when submitting samples; for active medical devices, electrical safety and environmental testing, and electromagnetic compatibility testing must be completed. Only when both performance testing and electromagnetic compatibility testing are passed can the product be determined to have passed registration inspection.

Table 1 Electromagnetic Compatibility Testing Items for Active Medical Devices

 II. Analysis of the Current Status of Medical Device Testing Institutions

(A) Main Functions

Currently, most medical device testing institutions in China are government-established institutions and government technical departments, whose main function is to provide technical support for the supervision of medical devices in China and undertake the pre-market registration, post-market supervision sampling, and standardization of medical devices in China[3].

1. Inspection Function

Inspection functions include registration inspection and supervision sampling. Registration inspection includes initial registration inspection and re-registration inspection every five years; supervision sampling is an important measure for the post-market supervision of medical devices in China. Each level of government supervision department conducts supervision sampling of medical devices at various stages of production, circulation and use every year to discover and solve potential problems with medical device products at each stage in a timely manner.

2. Standardization Function

China's medical device standards are divided into national standards, industry standards and registered product standards. Medical device testing institutions play a huge role in supporting the standardization of medical devices in China. They not only verify and audit the most common medical device registered product standards in the registration inspection of medical devices in China, but also undertake the formulation and revision of national and industry standards for medical devices in China. 

(B) Distribution and Testing Qualifications

At present, the purpose of establishing medical device testing institutions in various provinces (municipalities and autonomous regions) in China is to meet the needs of local medical device industry supervision, so the overall distribution and testing capabilities of medical device testing institutions are basically consistent with the development status of the local medical device industry. Provinces with a developed medical device industry have more testing institutions and higher testing levels, which meets the local government's needs for medical device industry supervision[4].

Currently, medical device testing institutions in China are concentrated in North China, East China, and Central South China, while there are relatively fewer in Northeast China, Northwest China, and Southwest China, as shown in Figure 1. Provinces with a developed medical device industry have more testing institutions and higher testing levels, which meets the local government's needs for medical device industry supervision[4].

Figure 1 Distribution of Medical Device Testing Institutions in Different Provinces (Municipalities and Autonomous Regions) of China

Data Source: Huoshi Creation

At present, there are a total of 53 medical device testing institutions with testing qualifications in China, including 10 national-level institutions (referred to as "Top Ten Centers"). The "Top Ten Centers" have relatively more qualifications and laboratory accreditation items, and their capabilities in various aspects are relatively strong. At the same time, the "Top Ten Centers" also undertake the standardization work of medical devices in China, as shown in Table 2.  

Table 2 Standardization Work of Medical Devices Undertaken by National Medical Device Testing Institutions in China

 (C) Business Analysis

Based on the calculation of various inspection reports issued throughout the year by 53 medical device testing institutions in China, including registration inspection, planned sampling inspection and commissioned inspection, the distribution of their business share is shown in Figure 3.

National-level testing institutions play a crucial role, not only undertaking a large amount of medical device testing work but also shouldering standardization responsibilities. Provincial-level testing institutions and institutions within the drug regulatory system still have considerable room for development. They need to continuously improve their scale and testing capabilities, narrowing the gap with national-level testing institutions to share more testing work and improve registration testing efficiency.`nbsp_tag

 III. Summary

Medical device registration testing is a very rigorous and important link, playing a vital role in registration review and post-market surveillance. At present, with the rapid development of the medical device industry, compared to the mature management system for pharmaceuticals, medical device registration testing is still somewhat inadequate, and testing institutions also face numerous challenges. Therefore, strengthening medical device supervision, improving quality standards and other management systems, and ensuring the safety and effectiveness of medical device use are particularly important.

For registration testing samples, it is recommended to refer to the management methods for pharmaceutical registration testing for sampling inspection, and at the same time strengthen the supervision of the quality system construction of medical device enterprises, urging enterprises to improve their quality management awareness.

Different types of registration testing institutions, especially provincial and other testing institutions, should focus on developing the testing capabilities of innovative medical devices, combining local industrial characteristics to develop professional expertise and testing systems, and creating highly specialized testing capabilities. By integrating new generation information technologies such as the internet, big data, and artificial intelligence with registration testing services, it is possible to promptly "divert" business, reduce queuing time, improve institutional utilization, and play a greater role in the healthy development of China's medical device industry.