Medical Device Manufacturing and Sales to Become Easier

Mid-sized Business Ombudsman, Experience-based Regulatory Innovation

Jubong Park, Small and Medium Business Ombudsman (Vice Minister level).
[Photo by Small and Medium Business Ombudsman]

[Asia Economy Reporter Kim Jong-hwa] In the future, medical device manufacturers and importers will be able to sell their products directly to consumers without registering as a sales business.

Park Ju-bong, Small and Medium Business Ombudsman (vice ministerial level), announced on the 22nd that he had agreed with the Ministry of Food and Drug Safety to partially improve the regulations on medical device sales business registration.

Until now, medical device manufacturers and importers could sell their medical devices such as blood pressure monitors and blood glucose meters to medical device handlers without registering as a sales business. However, when selling directly to consumers, a separate sales business registration was required, and the industry has continuously appealed to reduce this administrative burden.

Generally, to register as a medical device sales business, companies must prepare documents such as an application form, lease contract, and building register, and pay an administrative processing fee of about 10,000 KRW, with a processing period of up to three days.

Accordingly, the Small and Medium Business Ombudsman, in consultation with the Ministry of Food and Drug Safety, decided to expand the exemption from sales business registration so that medical device manufacturers and importers can sell their products directly to general consumers without registration by December next year.

Ombudsman Park said, "We are undertaking 'experience-based regulatory innovation' that companies can feel, targeting government ministries and local governments," adding, "We will continue to strive for small but meaningful regulatory improvements."

This content was produced with the assistance of AI translation services.