Korea’s Ministry of Food and Drug Safety (MFDS)

Overview of the MFDS

The Ministry of Food and Drug Safety (MFDS), formerly recognized as the Korean FDA, is the regulatory authority responsible for overseeing safety matters related to a wide range of products, including drugs, medical devices, food, functional food, and quasi-drugs. The MFDS regularly formulates new regulations, and it also aligns itself with many international standards. Notably, the MFDS staff actively engages in international harmonization efforts by participating in expert groups, contributing to the development of ICH guidelines, supporting the APEC Harmonization Center, and engaging in discussions on various topics and initiatives with members of the DIA.

Medical Device Registration in Korea

For medical device registration in Korea, medical devices are classified into four categories based on the level of risk they present when interacting with patients or operators, considering factors such as invasiveness, the type of energy delivered, and the biological outcomes. In addition, regardless of whether a device company is domestic or foreign, it is mandatory to obtain certification that attests to compliance with quality management system standards or Korean Good Manufacturing Practice (KGMP) requirements. Generally, the regulatory pathway and the timeframe for pre-market clearance differ according to the medical device class and the availability of standards or guidelines for the final product.

For most Class 1 devices, with the exception of sterile or measuring function devices, MDITAC offers a database where manufacturers can promptly submit details (notification) about their medical devices. For specific class 2 devices that require a scientific or technical examination report, the MFDS conducts reviews. However, for the majority of class 2 devices, third-party organizations evaluate the technical documents, and the Medical Device Information and Technology Assistance Center (MDITAC) grants product licenses. Typically, for class 3 and 4 devices, the MFDS undertakes an assessment of technical documents and subsequently issues the device license. The approval of a medical device registration application can vary from a number of months to over a year, depending on the complexity of requirements and the level of proficiency of the applicant’s regulatory affairs experts.

Establishing a medical device company in South Korea requires the acquisition of three distinct licenses:

• A License for Medical Device Manufacturing or Importation
• Certification for the Management of Medical Device Quality Systems, known as Korean Good Manufacturing Practice (KGMP) or GMP Korea
• Approval, Certification, or Notification for Medical Device Products

Pharmaceutical Registration with MFDS

Korea classifies pharmaceutical drugs into four main categories:

•   New Drugs: These are pharmaceutical compounds featuring novel materials, such as a unique chemical structure or composition, including combination drugs containing innovative materials as active components. Notably, pharmaceutical compounds listed in the “Korean Pharmacopoeia (PK)” or recognized foreign pharmaceutical compendia are exceptions – they are not classified as new drugs.
•  Pharmaceutical Products Requiring Data Submission: These encompass drugs with new indications, changes in active ingredient composition or strength, novel methods of administration, new dosing or administration guidelines, as well as preparations with new origins closely resembling approved drugs, etc.
•  Generic Pharmaceuticals: Generic pharmaceuticals are medications that are identical to previously approved drugs in terms of their active ingredient, strength, dosage form, efficacy, administration, and route of administration.
•  Orphan Drugs: An “orphan drug” is a medication designated by the MFDS when there is an urgent need for introduction due to a lack of alternative drugs. This designation applies to drugs used for rare diseases affecting 20,000 patients or less or for other diseases without appropriate therapies or pharmaceutical drugs, or those that offer significant safety or efficacy improvements compared to existing alternatives.

Obtaining marketing authorization for pharmaceuticals in Korea entails the submission of specific supporting documents, including those related to safety and efficacy, quality, the Drug Master File (if the active pharmaceutical ingredient of the drug requires separate registration), and compliance with Good Manufacturing Practices. The approval process varies in duration, typically ranging from a number of months to over a year, contingent on the complexity of requirements and the expertise of the applicant’s regulatory affairs professionals.