In the healthcare sector, the medical device industry has the largest growth potential for the Korean economy. In an era of life expectancy reaching 100 years, people need medical devices not only to prevent and treat diseases but to raise the overall quality of life. The nation has put particular efforts to make legislation, policies, and investments into the medical device industry recently.
Director at Johnson & Johnson Medical APAC
In April, the “Development of the Medical Device Industry and Innovative Medical Device Support Act” and the “In Vitro Diagnostic Medical Device Act” have passed the National Assembly.
Despite the government’s keen attention to and ample support for medical devices, the industry suffers from chronic problems. One of them is the regulator’s poorly managed evaluation body and the lack of staffs to approve medical devices. Without proper expertise and sufficient staff, any solution will end up as a stop-gap measure.
According to the Ministry of Food and Drug Safety, the government granted 3,202 certifications or medical devices in 2017, received 5,052 reports of medical devices, and evaluated 2,921 cases of technology document review. The numbers suggest that an official at the ministry had to manage more than 100 cases a year on average.
The ministry relegated the permission of first- and second-degree products to the National Institute of Food and Drug Safety Evaluation, but remains solely responsible for civil petitions and final examination.
The excessive review load is not the only problem. More serious is that the government is not catching up with the explosive growth of products using the technologies of the Fourth Industrial Revolution. Not only advanced nations but Korea is releasing medical devices equipped with Fourth Industrial Revolution-based technology platforms and artificial intelligence (AI).
However, the ministry has only one researcher and two reviewers for software-based digital products. Only three officials are working on setting up guidelines for approval, make and revise legal regulations, study standards, and analyze overseas cases. These works should be done independently and in a large group.
Medical devices require a high level of knowledge to understand their use and safety. People have no choice but to trust the food and drug safety ministry, which is responsible for medical devices’ safety.
The truth is inconvenient, however. While the medical devices industry’s steep growth with an annual growth rate of more than 8 percent demands extensive administrative work, the ministry’s Medical Device Safety Bureau has neither expanded nor hired more staffs in years.
The bureau and the Medical Device Safety Evaluation Division are at the forefront of ensuring the public’s safety. Whenever a safety issue comes up, people hold the government accountable.
However, the government in charge of such important work is understaffed. There is no professional reviewer who can handle the assessment of digital products, which makes industry officials complain about the lack of expertise and human resources in the government.
Let’s take a look at an overseas example. The U.S., advanced in deregulation, made an independent body consisting of experts for digital healthcare within the Food and Drug Administration (FDA). The U.S. government set up related rules, conducted fact-finding research, and came up with an innovative regulative frame to approve digital healthcare devices.
It is, of course, essential to make sub-regulations for the Innovative Medical Device Support Act. Unless a more urgent problem is solved, however, it will be difficult to ensure people’ safety or approve innovative medical devices as the industry wants.
I feel skeptical about how much impact the Innovative Medical Device Act will have on promoting digital devices and customized diagnosis technology through genetic analysis if the regulator lacks the expertise. That explains why the government needs a separate body to be able to carry out a professional evaluation.
All told, wouldn’t it be the food and drug safety ministry’s department dealing with medical devices that need to become more innovative than the relevant law?
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