Deciphering South Korea Regulation for Medical Devices

The world of medical and biomedical technology is evolving rapidly. Medical device manufacturers and other stakeholders in this market try to to discover emerging markets for their products. In this regard, South Korea is one of the countries where medical device manufacturers can market their products. South Korea is a leading country in medical device manufacturing. The Ministry of Food and Drug Safety (MFDS) governs the medical device ecosystem in South Korea. The innovation of the medical device market in South Korea can be understood from the fact that medical device manufacturers use a range of medical devices, from traditional equipment to software, as a medical device. This variability makes the Korean market very lucrative for both local and international medical device manufacturers.

In South Korea, it is the responsibility of MFDS to ensure the safe use of medical devices in the country. MFDS publishes standards by looking into the demands of industry and assessors. To enact its standards, MFDS mostly relies upon international standards, such as IEC and ISO.

Major Developments in South Korean Medical Device Environment

Some of the major developments that recently took place in South Korea are:

  • Software was categorized as a medical device in December 2018.
  • Around ninety subcategories have been introduced for software considered as medical devices.
  • Medical devices that use wired and wireless communication must take cybersecurity measures to protect them.
  • A digital healthcare team known as the Digital Health Devices Division was established in February 2022.

Medical device manufacturers should also become compliant with Korean Good Manufacturing Practice (KGMP) standards.

Developments on Digital Health Devices

We all are aware of the uses of software in medical devices and digital devices used on healthcare. These devices are also subjected to heavy regulations. Newer developments in South Korean environment of medical devices and digital healthcare have given sufficient consideration to digitized healthcare devices and systems. In this regard, the following two considerations are important:

In April 2022, new regulations were enacted to support commercialization of the products. This was done to:

  • Establish a coherent review with existing regulations and garner support from the development stage
  • Ensure holistic support across consultation, reviews on clinical investigations, and marketing authorizations.
  • Providing manufacturers with pre-market review guidelines.

Legislation regarding digital health devices

The recent developments focus on having laws and regulations to address the total lifecycle of digital healthcare devices encompassing product management, clinical investigations, and pre-market investigations, etc.

Modified QMS Regulations for In-Vitro Diagnostic (IVD) Devices

Recent developments have also modified QMS regulations for In-Vitro Diagnostic Devices (IVD). In this regard, the following classes of IVD devices have been classified:

  • Class 1: These devices are the ones having low potential of harm to the individuals or the public. Around 41% of IVDs are included in this class.
  • Class 2: These devices have a moderate potential of inciting harm to individuals and a reduced potential of causing harm to the public. This class contains 33.2% of the total population of IVDs.
  • Class 3: It includes IVDs having a high potential of causing harm to individuals and the public. It contains 21.4% of in-vitro medical devices.
  • Class 4: Class 4 IVDs also have a high potential of causing harm to individuals and the public. This class contains 4.4% of the total population of medical devices.

The Act on In Vitro Diagnostic Medical Devices was enacted on May 1, 2020. The Act emphasizes more on the importance of IVD devices. Moreover, the new act focuses more on early diagnosis and prevention of the disease than treating thedisease itself. Furthermore, establishment of a management system that considers differences between IVD and non-IVD devices is also required.

Newly Developed Guidance Documents for the Medical Device Industry

The newly developed guidance documents can be divided into the following categories:

  1. IVD
  2. Guidance for AI based Digital Pathology Software
  3. In Vitro Diagnostic Multivariate Index Assay (IVD-MIA)
  4. Guidance for Review and Approval of Medical Devices for In Vitro Diagnosis of COVID-19
  5. Digital Health AMD
    1. Guidelines for Safety and Performance Evaluation and Clinical Trial Protocol Preparation of Digital Therapeutics for Depression Improvement
    1. Guidelines for Safety and Performance Evaluation and Clinical Trial Protocol Preparation of Digital Therapeutics for Panic Disorder Improvement
    1. Guideline on Review and Approval of Cybersecurity of Medical Devices
    1. Guideline on Review and Approval of Artificial Intelligence Medical Devices
  6. Post-market
  7. Manual for Regulations on Renewal of Medical Devices Manufacturing and Approval, etc.
  8. Guideline to Submit Safety and Effectiveness Documents for Innovative Software Medical Devices Manufacturers Recognized by the Government.

Ensuring the Safety of Medical Devices

Newly enacted regulations in South Korea also call to secure the safety of medical devices. This refers to enhance

  • QMS inspection substantiality, and
  • Eliminating any blind spots in the safety management to ensure safe use of medical devices

Requirements for Importers

People willing to import medical devices into the South Korean jurisdiction have to fulfill certain requirements and criteria. For example:

  • They must be license holders for medical device import.
  • They should possibly be working as a subsidiary of an international distributor, a foreign manufacturer, a local manufacturer, or another legal entity.
  • They must be an applicant for the product registration process, and
  • They must be responsible for post-market surveillance.

Pre-market Requirements for Marketing Medical Devices

The pre-market requirements for medical devices include:

  • Having a product license, and
  • Approval from KGMP audit and quality system regulations.

Product Licenses and their Types

Medical devices in South Korea must acquire a pre-market registration from MFDS before they are imported and marketed. In this regard, there are two major types of product licenses worth-mentioning:

Pre-market Notifications for Class I Devices

These only require a documentary review on the product information.

Recently, some major developments took place which medical device manufacturers must know about if they want to market their devices in South Korea.

Pre-market Approval for Class II, III, and IV Devices

  • For Class II Devices: The medical application for Class II devices must be submitted to MDITAC (Medical Device Information & Technology Assistance Center MDITAC) for approval. This approval will be granted after complete technical document review by third-party reviewers.
  • For Class III and IV Devices: For these devices, the application must be first submitted to Head Office of MFDS. There, MFDS will perform a technical document review to grant the product approval. The applications for Class III and IV medical devices can be submitted together.

TDR and SER

Technical Document Review (TDR): It is reserved for those products that are almost same as the product that has been already approved.

Safety and Efficacy Review (SER): It is required for the devices that do not resemble the ones already placed on the market. These devices mostly fall under a new structure, have new performance, are meant for new intended use, or are simply newly developed medical devices.

Here, it is also important to mention that:

  • Third-party reviewers perform a review of medical technical documents for Class II medical devices, and
  • MFDS performs reviews for Class III and IV medical devices.

 In this blog, we have tried to cover all the major aspects of the medical device market scenario in South Korea. If you want to know more about the Korean regulations for medical devices, then you can contact us.

References

About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.