MFDS Medical Device Regulations:
Medical Devices in South Korea (S. Korea) are regulated by the Ministry of Food and drug safety (MFDS) formerly known are the Korean Food and Drug Administration (KFDA). Registering medical devices and IVD in S. Korea is a complex and challenging process. Most of MFDS regulations are not written clearly and some are only available in the Korean language.Defining the right regulatory strategy to be able to navigate through the challenging regulatory pathway is essential for successful products’ registration in S. Korea.
GRP Medical Device Services:
Global Regulatory Partners Inc. (GRP) has a global presence with a team of local experts in South Korea who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device in the South Korea’s market.
- MDFS. Medical Devices.
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Authorized local agent
In South Korea, the holder of a medical product registration must be a Korea-based entity. This entity is called the In-Country Caretaker (ICC). Foreign medical companies without their own local Korean office and who do not want to use their distributor as their local agent can have an independent ICC in South Korea maintain their product registrations in the name of the foreign manufacturer. Written below are brief bullet points on the responsibilities of an ICC.
RESPONSABILITIES OF ICC
- An ICC in S. Korea is responsible for applying to the Ministry of Food and Drug Safety (MFDS) for product approval.
- An ICC ensures that labeling is accurately added to the product (in Korean), documenting and reporting adverse events or product failures, etc.
- An ICC can also act as a liaison between the foreign manufacturer and its S. Korean distributor. Distributors usually require data from foreign manufacturers so they can be certified for Korean Good Import Practice, and an ICC can coordinate these requests.
GRP Local Agent Services in South Korea:
- Communication with the MFDS
- Assistance with MFDS inspections
- Adverse Effect Reporting
- Importation of products
- Organize and support MFDS consultation meetings
- Product registration
- Support importation process
- Post-market vigilance
- Manage Distributors
Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner. At Global Regulatory Partners Inc., (GRP) a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in South Korea.
Registering medical devices and IVD in South Korea is a complex and challenging process. Most of MFDS regulations are not that clear, are in Korean language and are changing constantly. Defining the right regulatory strategy to be able to navigate through the challenging regulatory pathway is essential for successful products’ registration in South Korea.
Our regulatory team in South Korea has the expertise in developing effective and tailored regulatory strategies that helped many foreign medical device companies to register their products quickly and efficiently.
GRP’s Medical Device Regulatory Strategy Services in South Korea:
- Identify and the latest regulatory requirements related to your medical device or IVD.
- Proactively identify challenges or issues that may delay the approval of your medical device in South Korea.
- Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
- Propose innovative solutions and approaches to circumvent these challenges ahead of time.
- Identify the most cost-effective way to get your medical product registered in South Korea.
Global regulatory Partner, Inc., provides a full regulatory affairs service from product concept throughout product development till product registration. Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in South Korea so they can successfully register and commercialize their products in South Korea’s market and maximize the value of their assets.
GRP regulatory affairs services include:
- regulatory intelligence,
- regulatory strategy,
- regulatory operations, and publishing;
- product registration,
- registration amendments;
- consulting meetings with regulatory authorities.
The first step in the registration process is the determination of the classification of your device according to the rules found in MFDS Notification No. 2014-110.
In South Korea (S. Korea), medical devices are classified as Class I, Class II, Class III or Class IV based on increasing risk. A database including medical device descriptions, classifications and categories can be found on the MFDS website. The registration of medical device in S. Korea will vary depending on device classification and the existence of a predicate device registered in S. Korea. In South Korea, some medical devices may be classified as “quasi-drug” or “drug” even though the same products are classified as medical devices in the US or EU.
Medical Device Pathways in S.Korea
Low Risk Class I Medical Devices:
- Subject to Pre-Market Notification (PMN).
Class II medical devices :
( There are 2 regulatory pathways)
- With a registered predicate (Substantial Equivalent), product registration applications qualify for third party review of the medical device and quality systems conformity assessments.
- All other Class II devices are subject to a Safety and Efficacy Review by the MFDS with an 80-day processing time.
Class III and Class IV devices:
- subject to Pre-Market Approval (PMA) with applications reviewed by the MFDS. The Substantial Equivalent review pathway takes 65 days and while the Safety and Efficacy Review pathway takes 80 days
Table 1: MEDICAL DEVICE CLASSIFICATION AND REGISTRATION TYPE IN SOUTH KOREA
|Device Class||Description||Type of Registration|
|Class I||Low risk||Pre-Market Notification|
|Class II||Medium risk|| 2 Possible Registration Pathways: |
• Substantial equivalent
• Safety and efficacy Review
|Class III||Medium-high risk||Pre-Market Approval|
|Class IV||High risk||Pre-Market Approval|
|Device Class||General Considerations for Medical device Registration in Korea|
|Class I||Applications are submitted to the MDITAC (Medical Device Information & Technology Assistance Center) through the MFDS e-submission systems and are considered accepted upon submission. A PMN number is issued on notification. § The Pre-Market Notification should include basic device information. § All documents must be translated into the Korean language.|
|Class II (Special Equivalent)|| There are approximately 350 Class II devices that MFDS considers “Special Equivalent,” which require a less robust application, i.e. no Technical File, as well as an expedited review by a Third Party Reviewer For Class II medical devices, pre-market approval procedures mainly depend on the device’s level of Substantial Equivalency (SE) with previously approved products. Medical devices are divided into four categories according to the KFDA SE standards: |
1. Announced Equivalent product
2. Equivalent product
3. Improved product
4. Novel product.
Announced Equivalent products are not subject to technical document review. Medical devices in the other three SE categories must go through the technical documents review process. Definitions and criteria to determine SE categories can be found in the revised Medical Device Act and on the KFDA website.
|Class II, III & IV|| §General Technical File OR Safety and Effectiveness Review (SER) should be prepared and submitted to KFDA or a Third Party for Review. § Clinical data must be included in these submissions. The MFDS may accept clinical data obtained in other markets. § All documents must be in Korean. |
• Local type testing for Class II, III, and IV devices may be required for registration if there are no equivalent foreign test reports. Local type testing is conducted by an independent laboratory (Korea Testing Lab is authorized to conduct type testing).
§ The foreign medical device company and the Korean License Holder must comply with Korea Good Manufacturing Practice (KGMP) quality system requirements. § KGMP certification includes an on-site audit of foreign manufacturing facilities. § KGMP certificate is issued by KFDA and is valid for 3 years. § KGMP certification is now required before product registration. § Pre-Market Approval license is issued by KFDA and does not have an expiration date. § Approval in the Country of Origin is not required for registration in Korea.
Our regulatory team in South Korea has the expertise in local regulatory requirements and regulatory processes needed to get medical devices and IVDs registered efficiently within KFDA.
GRP Product Registration Services:
- We can determine the correct classification for your device, and complete all necessary documentation, to ensure a smooth registration.
- Appointing us as your Korean Registration Holder, ICC, will allow you to maintain more control over your registrations and to add or remove distributors at any time.
- Our experienced consultants can update your existing FDA or ISO 13485 compliant quality system to meet Korea’s Good Manufacturing Practice (GMP) requirements.
- We can assist you with KFDA Lab certification coordination, if necessary.
One major step for companies registering medical devices in South Korea is compliance with the Korea Good Manufacturing Practice (KGMP) quality system regulations. Similar to ISO 13485 quality system standards, KGMP is required by the Korean Ministry of Food and Drug Safety (MFDS) for all Class II, III, and IV medical devices. MFDS will verify KGMP compliance via onsite inspections, conducted either by its own staff or with the assistance of Third-Party Auditor.
KGMP AND KOREA QUALITY MANAGEMENT FOR MEDICAL DEVICES
KGMP certification must be secured before any medical device company can sell any Class II, III and IV medical devices on the South Korean market. To obtain KGMP certification, medical device companies must submit documentation to MFDS or authorized third party auditor, to demonstrate that their medical devices comply with KGMP quality system requirements.
Following submission of KGMP certification application, companies’ manufacturing site will likely undergo inspection by a qualified third-party auditor and/or MFDS depending on devices’ classification:
- For Class II medical devices, manufacturing sites are subject to third-party audits only.
- For Class III and IV devices, manufacturing sites are subject to a combined audit by a third-party reviewer and MFDS.
As of 2015, companies must undergo KGMP auditing at the beginning of product registration, rather than after the product is approved by the MFDS. Furthermore, in vitro diagnostic (IVD) products are now regulated as medical devices instead of pharmaceuticals. IVD manufacturers must therefore comply with KGMP requirements as well.
Our quality team in South Korea has the expertise in compiling and submitting to MFDS the application for KGMP certification in line with MFDS quality standards.
GRP QMS implementation Services:
- Document and records control
- Training on regulatory requirements and internal procedures
- Design and development
- Risk management
- Software development (if applicable)
- Supplier evaluation
- Control of measurement equipment
- Perform internal quality system audits
When medical devices are registered in reference foreign countries, such as US, EU, Canada and Japan, foreign clinical trial data is usually accepted by the MFDS. Local clinical trials are generally not required for device approval, except for certain Class IV medical devices. The MFDS prefers foreign clinical trial data published in a professional journal. However, they will accept unpublished data if the studies were conducted by an acceptable research organization that followed Good Clinical Practice (GCP).
Conducting Clinical Trials in S.Korea
Conducting clinical trials in South Korea is cost effective, and the data generated is well regarded internationally. GRP can help pharmaceutical manufacturers assess the suitability of South Korea as a site for conducting clinical trials for their drug. We also provide assistance in researching and analyzing the appropriate clinicians and institutions and in screening CROs as prospective clinical trial managers in South Korea.
To obtain approval for clinical trials in S. Korea, companies must go through the clinical trial authorization (CTA) process. Before beginning the pharmaceutical clinical trial in Korea, applicants must choose trial sites and a Principal Investigator (PI). Korean PIs must be well educated, trained, and have foreign language abilities. The sponsor and head of the clinical trial site will sign a written contract before the trial begins. If a CRO is used, the sponsor must write a contract outlining a set of tasks for the CRO to complete.
In order to conduct the clinical trial itself, companies must execute further steps, including receiving approval from an Institutional Review Board (IRB), recruiting subjects and trial personnel, and ensuring quality standards, etc. Companies should use the MFDS consulting services for pre-investigational new drugs in order to determine which documents will be needed. All documents submitted by the sponsor for the clinical trial authorization (CTA) should be in Korean.
There is a total of 166 clinical trial centers designated by MFDS, providing diverse and robust environments for clinical trials.
Requirements for Approval of Clinical Trial Applications
In order to submit a clinical trial application (CTA) for a medical device in S. Korea, foreign companies must first prepare a clinical investigation plan, along with documents proving that Good Manufacturing Practice (GMP) standards are met by the foreign company’s manufacturing facility.
If the device is used to treat life-threatening illnesses, a series of supplementary documents must be sent to the Investigational Review Board (IRB) for approval as well.
Medical devices trials normally take only 30 days to be approved in S. Korea.
Electronic Filing System (KiFDA)
Korea’s clinical trial registration process – filing and submitting pre and post approval registration forms – is now online. After the medical device is approved, the e-registration system is available for applicants and CROs.
GCP Requirements for Conducting Clinical Trials in Korea
Good clinical practice in Korea (K-GCP) is aligned with international guidelines (ICH-GCP).
Adverse events must be submitted to the MFDS by manufacturers, distributors, and clinics, among others. If the incident resulted in death or life-threatening injuries, a report must be filed within seven days, with a follow-up eight days later. Events causing hospitalization, disability, or deformity must be reported within fifteen days. All other adverse events must be reported within thirty days.
After clinical trials in Korea are completed, companies should file a report to the MFDS, including all data, therapeutic effects, and adverse events from the trial.
Our clinical team in South Korea has the expertise in obtaining the CTA approval from MFDS and manage clinical trials for medical device companies efficiently.
GRP clinical service for national and/or international trials :
- Protocol development
- Site and investigator identification and qualification
- Site initiation and training
- Clinical monitoring
- Medical monitoring
- DSMB coordination
- Statistical analysis
- Electronic data capture
- Electronic Trial Master File
- Full-service data management
- ClinicalTrials.gov registration and management
- Central lab oversight and coordination
- Site quality assurance audits
- Integrated final Clinical Study Report
Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in South Korea. As the MFDS Regulatory authorities expect precise, clear and well-written documents, any bad writing or translation can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.
Health authority consultation
Consultation meetings with the MFDS can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.
GRP regulatory affairs team supports:
- Writing ,
- Preparation and submission of the meeting package to the health authority,
- Prepare the questions to health authority based on the status of your product’s development and future plan,
- Provide support during the meeting,
- Write the meeting minutes and develop the appropriate action plan after the consultation meeting.
- GRP regulatory affairs team has organized and supported over 100 consultation meeting with different health authorities in different markets.