China's medical device industry enters a golden age, with increased domestic and international demand, expanding market size, and enterprises standing out from the competition.

Driven by the global epidemic situation, population aging, and policy dividends, the growth rate of related medical device products is still increasing, and competition in the sector has become fierce. Traditional home appliance, technology, and Internet giants such as Gree, Huawei, and Tencent are all entering the market, but compared with this, companies that entered the market earlier and made early layouts have a greater advantage. Taking Chaosi Electronics as an example, it not only has extensive layouts in domestic and foreign markets and has obtained certifications from the US FDA and EU CE in advance, but also has more than 300 international patents. Its pulse oximeter products currently have more than 100 Models, including fingertip, handheld, wrist-mounted, and desktop types. These advantages in the industry cannot be surpassed by cross-border companies in the short term.

The stability of the domestic market, the influence of multiple factors, and the rise of Chinese medical device companies all indicate that the golden age of domestic medical devices has arrived. Medical device companies that entered the market early and made early layouts have better technological iterations, longer-term cultivation of usage habits, and more efficient sales channel systems. Their first-mover advantage will gradually become apparent and lead the development of the entire era.

Medical device safety is closely related to public life and health. In order to thoroughly implement the newly revised "Regulations on the Supervision and Administration of Medical Devices", promote the innovative development and high-quality development of the medical device industry, popularize the safe use knowledge of medical devices, and better meet the public health needs, the NMPA launched the 2021 "National Medical Device Safety Publicity Week" event from July 19 to 23, with the theme of "Safe Use of Medical Devices and Innovative Development."

Medical Device Safety Publicity Week is about to begin

The key points of this publicity activity are to showcase the achievements of medical devices in the centenary of the founding of the party, to disseminate the "Regulations on the Supervision and Administration of Medical Devices" and its supporting regulations, to promote technological innovation and high-quality development of medical devices, and to carry out popular science publicity on medical device knowledge. Provincial-level bureaus are required to strengthen organizational leadership, highlight activity priorities, enhance the impact of activities, and carefully summarize work conditions to ensure the smooth progress of the publicity week.

The development of medical devices in China has been rapid. After liberation, China established a medical device industrial system with a relatively weak foundation. In the early 1990s, foreign medical devices entered the Chinese market, almost destroying the domestic medical device industry. Around 2005, after more than 20 years of national economic development and talent cultivation accumulation, the industrial wave of Chinese medical devices gradually emerged, and a large number of talents in the industry matured. To this day, the Chinese medical device industry is entering its golden age of development.

Through years of effort, China has achieved localization of some products, such as in-vitro diagnostics and monitoring equipment, but in other areas, such as medical imaging, continuous exploration is still needed. The "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the new "Regulations"), which came into effect on June 1 this year, for the first time incorporates the encouragement and support of innovative development of medical devices into the legal framework, emphasizing the "guaranteeing the safety and effectiveness of medical devices, protecting human health and safety" while also "promoting the development of the medical device industry". As the highest-level legislation in the field of medical device supervision, this revision of the new "Regulations" is carried out against the backdrop of China's implementation of medical device review and approval system reform and the pilot program of the medical device registrant system. It is a landmark achievement in medical device industry regulations and will play an important role in promoting innovation and high-quality development of China's medical device industry.

In the past two decades, China's pharmaceutical regulation has undergone continuous reform and strengthening. Medical device safety is related to the well-being, economic development, and social harmony of the entire population. The National Medical Products Administration's holding of a series of science popularization and publicity activities is in line with the requirements of "the strictest standards in four aspects." The pharmaceutical industry will continue to undergo transformation and upgrading.

The CIO Compliance Assurance Organization focuses on research in pharmaceutical regulatory science, promotes compliance and rapid development of the pharmaceutical industry, strives to serve China's pharmaceutical transformation and upgrading, and aims to become the most professional third-party service institution. The CIO Compliance Assurance Organization provides quality management system services for the entire lifecycle of medical device registrants and filers, GMP for manufacturing enterprises, and GSP compliance audit services for trading enterprises. It comprehensively investigates all compliance risk points and assists enterprises in solving identified problems in the most optimal way.

The CIO Compliance Assurance Organization, as an independent third party, actively participates in social governance in the pharmaceutical field, making pharmaceuticals more reliable and the public more at ease.

Four Important Considerations for the Domestic Production of Imported Medical Devices in China

By establishing a foreign-invested enterprise in China, the registrant of imported medical devices can produce Class II and Class III products that have already obtained import medical device registration certificates within China. This can optimize the supply chain, reduce production costs, and provide more convenience for the localization of imported medical devices.

In recent years, there has been a growing demand from the industry to optimize the registration application materials for the production of imported medical device products in Chinese enterprises and to avoid duplicate submissions of registration application materials. To implement the requirements of the Party Central Committee and the State Council to deepen the "streamlining administration and delegating power" reform and optimize the business environment, and to deepen the reform of the medical device review and approval system, the "Announcement of the National Medical Products Administration on Matters Concerning the Production of Imported Medical Device Products in Chinese Enterprises" (No. 104 of 2020) was issued. Based on this announcement, this article summarizes the matters that should be noted when producing products with imported medical device registration certificates in Chinese enterprises, for reference.

A foreign-invested enterprise needs to be established in China, and the original import registration certificate must be valid.

First, it is clear that the overseas registrant of imported medical devices cannot directly entrust domestic enterprises to produce registered products. The registrant of imported medical devices must establish a foreign-invested enterprise in China and produce Class II and Class III products that have already obtained import medical device registration certificates through it. This also includes products that have obtained medical device registration certificates in Hong Kong, Macao, and Taiwan.

In addition, if a foreign registrant invested in by a Chinese enterprise produces Class II and Class III medical devices that have obtained import medical device registration certificates in China, the Chinese enterprise investing in the foreign registrant can also apply for registration of the product as the registration applicant. This means that domestic medical device enterprises with international strategies can indirectly obtain varieties with existing import registration certificates by acquiring the equity of import registrants, thereby quickly achieving localization of these varieties.

Furthermore, the medical device registration certificate for the manufactured product must be valid; products whose original import registration certificates have expired or been cancelled may not be produced.

Ensure the Equivalence and Traceability of Domestic and Foreign Quality Management Systems

The drug regulatory authorities conduct comprehensive verifications of domestic registration applicants according to the medical device registration quality management system verification procedures. They will focus on the equivalence and traceability of domestic and foreign quality management systems, as well as whether the changes in the production process caused by the change will create new risks and lead to changes in registration matters.

Therefore, domestic registration applicants should ensure that ① the product design does not change and the quality system remains basically consistent; ② the safety and effectiveness of the product have not changed significantly.

Registration Application Materials Optimization; Some Original Registration Materials of Imported Medical Devices Can Be ReusedMaterials

For the production of imported medical device products in domestic enterprises, the drug supervisory and administrative department will optimize the registration application materials according to the existing regulatory framework.

(1) The foreign-invested enterprise established by the registrant of imported medical devices in China, as the registration applicant, submits a domestic medical device registration application to the drug supervisory and administrative department. Except for the registrant's name, address, and production address, the content of the registration application should, in principle, remain consistent with the corresponding imported medical device registration certificate and the "Registration Application Materials Requirements for Medical Devices/In Vitro Diagnostic Reagents".

(2) In the registration application materials submitted by the registration applicant, the summary information, research data, clinical evaluation data, product risk analysis data, summary information of in-vitro diagnostic reagents products, research data on main raw materials (when applicable), research data on main production processes and reaction systems (when applicable), analytical performance evaluation data, data for determining positive judgment values or reference ranges, stability study data, clinical evaluation data, and product risk analysis data of medical device products can be submitted as the original registration application materials of the imported medical devices. The importer and the domestic registration applicant should ensure the relevance and support of the above materials to this registration application.

(3) The registration application procedure should be implemented in accordance with the "Regulations on the Administration of Medical Device Registration," the "Regulations on the Administration of In Vitro Diagnostic Reagent Registration," and the relevant regulations on electronic submission of medical devices.

Newly Obtained Registration Certificates and Original Imported Medical Device Registration Certificates Are Independently Managed

Upon submission and approval of the registration application, the remarks column of the registration certificate should indicate the registration number of the relevant approved original imported product's medical device registration certificate, which will facilitate the identification and traceability of the relevant transferred production product registration certificates by drug supervisory and administrative departments at all levels. In addition, the domestic medical device registration certificate and the original imported medical device registration certificate are managed independently.

Overall, the production of products with imported medical device registration certificates in Chinese enterprises helps accelerate the localization of imported medical devices and promotes and drives the innovative development of domestic medical devices, increasing the accessibility of medical devices, better meeting the public's health needs, and promoting the high-quality development of the entire medical device industry.