Machinery / Industrial Parts & Tools

Due to the prevalence of the mutated new crown virus delta strain and the uneven supply of vaccines, the current global new crown epidemic is once again facing a severe situation. According to data released by the World Health Organization, more than 200 million people worldwide have been infected with the new crown virus, and 4.37 million people have died from the new crown pneumonia epidemic. The global economic recovery and the passage of international trade have been re-shrouded in haze.

In the difficult moment of the global fight against the "epidemic", "Made in China" medical devices have become the ballast stone of the world's fight against the "epidemic", and at the same time exposed their shortcomings in global competition. The lack of understanding and accumulation of market access and regulatory knowledge of overseas listing destinations is currently the most prominent challenge. To this end, our reporter interviewed Zhang Song, the global senior marketing manager of UL medical product market access, a world-renowned third-party testing and certification organization, to discuss the future compliance trend of medical device exports.

Exports increased by 112%!

In 2020, the new crown pneumonia epidemic will sweep the world, and the demand for masks, protective clothing, ventilators, testing reagents and other products around the world has skyrocketed, which has greatly promoted my country's medical device companies to go global. The rapid growth of my country's medical equipment exports that year has become a bright spot in foreign trade.

According to China's customs statistics, my country's foreign trade in medical devices reached US$139.8 billion in 2020, a year-on-year increase of 112%. Among them, exports amounted to US$101.5 billion, a year-on-year increase of 244%. In May of that year, the export value of medical equipment reached its peak.

Judging from the export trade data of commodity categories, the trade volume of my country's five major commodities of medical masks, medical protective clothing, ventilators, infrared thermometers and diagnostic reagents in 2020 is eye-catching. The export value of medical masks increased by 889% year-on-year, and the year-on-year growth of medical protective clothing was even as high as 11.27%.

In terms of export markets, in 2020, my country's medical device export destination countries are mainly the United States, the United Kingdom, Germany, Japan and France. Medical device products exported to the United States amounted to 26 billion U.S. dollars, and the export value of masks and protective clothing was 14.8 billion U.S. dollars, accounting for more than 50%.

Behind the highlights, it also reflects some of the pain points of my country's medical equipment "going to sea", the most important of which is the "blind spots" of market access and regulatory regulations. There are more than 200 countries and regions in the world, and each country and region has different policies, laws, entry thresholds, and qualification requirements. For most small and medium-sized manufacturers, solving this problem determines the sustainability of "going abroad" The essential.

EUA may be suspended

The United States is my country's largest export market for medical devices. To enter the US market, medical device products need to be certified by the Food and Drug Administration (FDA) before they can be marketed.

During the severe epidemic in the United States, in order to accelerate the improvement of the availability of respiratory equipment such as ventilators and respirators, and personal protective equipment (PPE) and other medical devices, US regulatory agencies, including the FDA, have established emergency routes for market access (EUA). To help respond to public health emergencies of new coronary pneumonia. For example, the FDA issued various EUAs as early as February 2020, and subsequently issued EUAs for personal protective equipment in March of that year. At that time, Chinese medical device manufacturers and exporters were striving to accelerate the entry of "Made in China" medical device products into the US market under the US policy of accelerating the regulatory review path.

Zhang Song said that with the widespread implementation of global epidemic prevention and control measures, the demand for epidemic prevention and control and rescue equipment in the US market has gradually stabilized, and the US FDA and other regulatory agencies intend to suspend EUA applications. For example, in March 2021, the FDA no longer accepts applications for emergency use authorization of PCR nucleic acid testing equipment, and at the same time withdraws some of the products that are applying for; at the end of June, the FDA considered non-NIOSH (National Institute of Occupational Safety and Health) certified breathing Masks and purification system equipment will no longer be in short supply for epidemic prevention, and personal protective equipment is expected to be removed from the EUA first. This means that once the EUA application is suspended or stopped, many Chinese manufacturers will have to obtain complete regulatory licenses or approvals in order to maintain compliance in the U.S. market and other markets during the epidemic.

Three elements of medical device export

For domestic and foreign manufacturers, obtaining market access approval from the US FDA is a complicated and time-consuming process. Zhang Song believes that domestic exporters of medical devices must master three major elements before exporting.

The first element is that Chinese medical device manufacturers and exporters should be aware that the US FDA has its own medical device quality management system (QMS) requirements, namely FDA Quality System Regulation (QSR), which is in line with ISO 13485 There are differences in quality system standards. If domestic manufacturers and exporters only meet the requirements of the ISO 13485 quality standard, they cannot meet the requirements for listing in the United States.

The second element is that for all medical device manufacturers that do not have an entity in the United States, they must appoint an FDA agent in the United States as their local representative and manage the FDA's pre-market review work on their behalf.

The last and most critical element is that manufacturers must ensure accurate risk-based product classification for devices submitted to FDA for review. It is reported that according to the different risk levels, the FDA divides medical devices into three categories (I, II, and III), with category III having the highest risk level. For any kind of medical device to be marketed in the United States, it is necessary to clarify the classification and management requirements of the product applying for listing. In addition, the FDA's classification has an equivalent system, and device applicants must prove that their device is substantially equivalent to an "equivalent device" that has been compliantly listed on the US market. High-risk Class III medical devices and some medium-risk Class II medical devices require additional and more important pre-market application materials, including clinical data.

In response to the complexity of US market access, Zhang Song added that Chinese medical device manufacturers and exporters can consider making full use of the FDA’s Pre-Sub (Pre-Submission) program, which will allow US market applicants to The FDA consults with the US FDA before submitting a formal listing application to resolve any issues, disputes, and doubts in the regulatory review process.

MDR brings special challenges

On May 26, 2021, the European Union's revolutionary medical device regulation MDR was officially implemented. Zhang Song pointed out that the changes in MDR regulations will have a major impact on all interest groups, whether for Chinese manufacturers, exporters, or EU distribution partners.

The promulgation of the new EU medical device regulation MDR requires the European Notified Body to review the safety and performance declarations of medical devices more comprehensively and thoroughly to ensure its CE certification compliance and European market license sales. For Chinese manufacturers and exporters who are active in the European market or interested in the CE mark certification of their devices, they will face a major and special challenge, namely the availability of the current notified body.

Zhang Song explained that manufacturers and exporters need to confirm whether the current notified body is designated to perform MDR certification under the new MDR regulations. Up to now, 22 notified bodies have been authorized to provide MDR CE compliance certification, but until more notified bodies are authorized, some manufacturers may find it difficult to find a qualified notified body to review their devices. In addition, for medical device companies whose current notifying agency is already one of the 22 MDR-authorized notifying agencies, it may also face a longer waiting time for conformity assessment review than usual.

Help Chinese products go to market quickly

The new crown pneumonia epidemic has spawned a strong demand for medical device products. A large number of medical device and in vitro diagnostic (IVD) companies hope that their products can meet the market requirements while meeting safety and effectiveness as quickly as possible. It is reported that the leading company in the field of nucleic acid molecular diagnostics in China, with the help of UL's professional and fast service, completed the preparation of all technical documents for CE certification and applied for submission in only 4 days, serving the world for its new coronavirus nucleic acid detection reagents. The epidemic prevention and control has opened up a fast track.

Public information shows that in April 2017, UL acquired Emergo, a world-renowned third-party medical device overseas market compliance consulting agency, and officially changed its name to Emergo by UL, focusing on medical device and IVD device market access compliance and safety services. The expert team of Emergo by UL brings together consultants on regulatory affairs supervision and quality system compliance (RA/QA) from more than 25 countries and regions in Europe, the United States, and Asia (including such as the United States, Europe, China, Japan, Brazil, etc.). Provide a comprehensive one-stop solution for comprehensive medical device registration, implementation of quality management system, local representative of registration place, clinical research compliance and regulatory strategy formulation, etc., to help Chinese medical device companies understand and apply for overseas market compliance listing registration.

Zhang Song finally stated that for those medical device manufacturers and exporters seeking efficient, collaborative, and internally automated supervision, Emergo by UL has independently developed RAMS (Regulatory Affairs Management Suite) online management platform for regulatory affairs, which can provide disruptive Digital medical device market compliance tracking and monitoring. At present, more than 14,000 medical device and IVD companies have successfully registered on the platform to facilitate the independent management of regulatory affairs.