A Preliminary Exploration of the Problems and Solutions in the Development of China's Medical Device Industry

The medical device industry involves medicine, machinery, electronic information, bioengineering, materials science, and other fields. It is a multidisciplinary, knowledge-intensive, and capital-intensive emerging industry. Compared with developed countries, China's medical device industry has a weak foundation. At the same time, the rapidly growing medical needs of society are huge, stimulating the rapid growth of the domestic medical device market.In recent years, the growth rate of China's medical device market has been significantly higher than that of other countries.

With the rapid development of the industry, more high-tech medical device products have been launched, bringing new challenges to medical device supervision and putting higher demands on the overall quality and ability building of the regulatory team. This paper analyzes the current development of the medical device industry and the corresponding regulatory work, and takes Tianjin as an example to discuss the problems faced by the development of the medical device industry, and puts forward preliminary solutions and suggestions.

Overview of Medical Device Industry Development

The rise in health needs has driven progress in the medical and health industry and objectively promoted the expansion of the global medical device market. According to statistics released by EvaluateMedTech, the global medical device market sales in 2017 were approximately US\$405 billion, a year-on-year increase of 4.6%, and sales are expected to reach US\$594.5 billion in 2024. Between 2017 and 2024, the global medical device market CAGR (compound annual growth rate) was 5.6%.

According to other relevant statistics,In 2018, the size of China's medical device market was approximately 530.4 billion yuanFrom 2014 to 2018, the domestic medical device market CAGR was 20.02%, higher than the global growth rate. Overall, the domestic medical device market performed brilliantly.

Current Status of Medical Device Supervision

In the discussion of the current status of medical device supervision in China, we can present it from several aspects: medical device classification management, the number of production and operating enterprises, and regulatory measures.

Medical Device Classification Management

According to the provisions of the "Regulations on the Supervision and Administration of Medical Devices",China implements classified management of medical devices according to the degree of riskFirst-class medical devices have a low degree of risk and can be guaranteed to be safe and effective through routine management, such as medical X-ray films and gauze; second-class medical devices have a moderate degree of risk and require strict control management to ensure their safety and effectiveness, such as medical suture needles (without thread) and sphygmomanometers; third-class medical devices have a higher degree of risk and require special measures to strictly control management to ensure their safety and effectiveness, such as implantable cardiac pacemakers and vascular stents.

Number of Production and Operating Enterprises

According to the statistics from the National Medical Products Administration Information Center cited in the "China Medical Device Industry Development Report (2019)",As of 2018, there were 17,236 medical device manufacturing enterprises in China, an increase of 1,112 compared to the previous year.Among them, 1,997 enterprises can produce Class III medical devices; 9,189 enterprises can produce Class II medical devices; and 7,513 enterprises can produce Class I medical devices.

As of 2018, there were 511,000 legally registered or filed medical device operating enterprises in China,Among them, 291,565 enterprises only operate Class II medical device products, 66,987 enterprises operate Class III medical device products, and 152,488 enterprises operate both Class II and Class III medical device products.

Regulatory Measures

China implements registration management (Class II and Class III medical devices) and filing management (Class I medical devices) for medical products entering the market; after entering the market, management is mainly carried out through supervision and inspection, adverse event monitoring, and supervision and spot checks.

Supervision and Inspection According to the inspection methods and purposes, supervision and inspection are divided intoRoutine inspections, special inspections, compliance inspections, inspections with cause, and follow-up inspectionsThese types of inspections aim to check whether the production and operation conditions of enterprises continue to meet regulatory requirements, whether the quality management system is sound and can continue to operate effectively, and whether enterprises strictly follow mandatory standards or product technical requirements to organize production, and whether their products meet the standard specifications.

Adverse Event Monitoring Medical device adverse eventsrefer to various harmful events that occur under normal use of approved, qualified medical devices that cause or may cause harm to the human body. By monitoring adverse events, the potential risks of medical device products can be controlled to the maximum extent, ensuring the safe and effective use of products.

According to the relevant provisions of the "Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events",The holder of a medical device marketing authorization should conduct continuous research on its marketed medical devices, assess the risk situation, and assume the responsibility for monitoring medical device adverse events.The drug supervision and administration department should supervise and inspect the work of the holder and operating enterprises on medical device adverse event monitoring and re-evaluation according to their responsibilities.

Supervision and Spot Checks Quality supervision and spot checks of medical devices refer to activities in which the drug supervision and administration department samples and confirms samples according to the statutory procedures, designates qualified medical device testing institutions to conduct standard conformity testing, and conducts announcements and supervision and management based on the results of the spot checks. The drug regulatory department regularly develops spot check plans, selects spot check varieties, conducts supervision and spot checks, investigates and deals with enterprises for non-compliant problems found in spot checks according to law and regulations, and urges enterprises to implement rectification measures.

Problems Existing in Industrial Development

Taking Tianjin as an example, the problems faced by the development of the local medical device industry mainly focus on three aspects: lack of overall planning for industrial layout, the system of combining production, education, and research has not yet been formed, and the awareness of enterprise law-abiding and integrity still needs to be improved.

Lack of Overall Planning for Industrial Layout

Currently, the layout of the medical device industry in Tianjin hasScattered distribution, low correlation, lack of unified management, and failure to form a concentrated development patternAnd other issues.

Tianjin currently has two medical device and biopharmaceutical industrial parks: the National Biomedicine International Innovation Park Industrial Zone and the Tianjin Pharmaceutical and Medical Device Industrial Park.

The National Biomedicine International Innovation Park Industrial Zone is located inBinhai High-tech Zone, TianjinThe industrial park currently has 60,000 square meters of business incubation base and nearly 100,000 square meters of scientific and technological achievements transformation base, with relatively complete park hardware facilities and supporting policies. Tianjin Pharmaceutical and Medical Device Industrial Park is located in Beichen District, Tianjin. The planned land area of the park is 8.79 square kilometers, and the approved starting area is 3.33 square kilometers. In the future, the park will focus on "pharmaceutical manufacturing", "pharmaceutical equipment and medical device manufacturing", and "pharmaceutical R&D pilot test and transformation" as its core development sectors.

However, in the early planning of the above-mentioned parks, there was a lack of clear research on the regional characteristics, resources, and development of related products, resulting in unclear industrial positioning, low correlation, and inconspicuous agglomeration effects in the subsequent industrial layout. To a certain extent, this has resulted in waste of land and HR, and limited the park's ability for cyclical development.

The industry-academia-research system has not yet been formed.

In Tianjin and its surrounding areas, there are more than 20 research institutions related to medical devices, with a significant advantage in the concentration of intellectual resources. At the same time, Tianjin has a number of well-known universities such as Nankai University and Tianjin University, with many universities offering biomedical engineering majors, which provides a talent reserve for Tianjin's medical device industry. In addition, Tianjin has dozens of tertiary Grade A hospitals, providing certain clinical resources for the R&D and commercialization of medical devices. The existence of these conditions has provided strong support for the innovative development of Tianjin's medical device industry.

However, in recent years, the development of Tianjin's medical device industry hasfailed to fully integrate with intellectual resources, clinical resources and other advantageous resources,which has led to a certain degree of disconnect between research and development and industry.

The law-abiding and integrity awareness of enterprises still needs to be improved.

Enterprises bear the primary responsibility for product quality and safety.Some enterprises blindly pursue profits, focusing on sales while neglecting production, and have weak law-abiding and quality awareness.Some enterprises invest little or even no money in legal and quality management, and do not have a dedicated legal department or staff, and cannot keep up with the changes in laws and regulations, and are slow to react to new standards and regulations; some enterprises deliberately lower product quality standards to reduce costs; some enterprises do not organize production according to the approved and filed production process, and arbitrarily change the process flow or technical parameters; and some enterprises forge production records and other quality management system documents. The above behaviors all pose potential risks to the quality and safety of products produced by enterprises.

Solutions and countermeasures

In response to the above problems, we can focus on leveraginginter-departmental synergy, encouraging industrial agglomeration, supporting key enterprises, and exploring regional cooperationto address them.

The healthy development of the industry requires the concerted efforts of relevant departments. Regulatory departments can cooperate with relevant departments involved in industry development, such as industry associations, to regularly study the problems faced by enterprise development and discuss measures to promote industry development and improve regulatory efficiency.

At the same time, we can communicate with local governments and suggest that they strengthen their policy support forcharacteristic medical device enterprises and parks in their jurisdictions, encouraging the formation of regional industrial alliancesWhen enterprises that have obtained medical device production licenses and product registration certificates open new factories in other provinces, regulatory departments can adopt the method of simultaneous processing of "two certificates" to simplify pre-approval and optimize the business environment.

Formajor scientific and technological projects or key R&D plan supportmedical device products, andproducts with leading domestic technologyrelevant departments can provide a "green channel" for their application and registration, and give priority to processing.

In addition, with the implementation of the medical device registrant system, the pre-market investment cost of enterprises will be further reduced, which will help attract more social resources into the medical device industry, and objectively help encourage innovation,improve the conversion rate of scientific research achievements.。

In the future, building a regional cooperation mechanism for medical device supervision may become a trend. The establishment of this mechanism can promote the healthy and coordinated development of the medical device industry in related regions. Regulatory departments can use this mechanism to gradually achieve the goals of sharing regulatory resources, mutual recognition of testing reports, and mutual exchange of regulatory information, gradually achieving the purpose of saving administrative costs and reducing the burden on enterprises.