South Korea

Medical Devices

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. 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.

Related Links:

MDFS. Medical Devices. https://www.mfds.go.kr/eng/wpge/m_39/denofile.do

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

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.

Regulatory Strategy

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.

Regulatory Affairs

Global regulatory Partner, Inc., provides a full regulatory affairs service from product concept throughout product development till product registration.

Our regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with regulatory authorities.

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.

Product registration

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. 

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

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.

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.

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 MFDS.

Related Links:

MFDS. Medical Devices. https://mfds.go.kr/eng/wpge/m_39/denofile.do

Quality

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.

Clinical

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).

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.

Medical writing

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 includes: 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, 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 numerous consultation meeting with the MFDS health authorities.

Pharmaceuticals

South Korea’s regulatory systems are diverse, and oftentimes challenging to navigate. The South Korean regulatory agency, the Ministry of Food and Drug Safety (MFDS), has its own set of regulations and customary manner of conducting business. Thus, determining the most effective and efficient strategy to obtain approval for your pharmaceutical product(s) without sufficient knowledge and experience with the S. Korean regulatory authorities can become exhaustive and costly. 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.

Related Links:

MDFS. Drugs. https://www.mfds.go.kr/eng/wpge/m_17/denofile.do

Authorized local agent

In South Korea, the holder of a medical product registration must be a S. 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 Korea maintain their product registrations in the name of the foreign manufacturer.

RESPONSABILITIES OF ICC

  • An ICC in Korea is responsible for applying to the Ministry of Food and Drug Safety (MFDS) for product approval, making sure that Korean labeling is accurately added to the product, documenting and reporting adverse events or product failures, etc.
  • An ICC can also act as a liaison between the foreign manufacturer and its 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
  • Product storage in an establishment with ICC licensing
  • Support importation process
  • Post-market vigilance
  • Manage Distributors

Regulatory intelligence

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.

At Global Regulatory Partners Inc., 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.

Regulatory Strategy

South Korea’s regulatory systems are diverse, and oftentimes challenging to navigate.  Thus, determining the most effective and efficient strategy to obtain approval for your pharmaceutical product from each regulatory body without sufficient knowledge and experience with Asian regulatory affairs can be a very difficult task.

Our regulatory team in South Korea has the expertise in developing effective and tailored regulatory strategies that helped many foreign pharmaceutical companies to register their products quickly and efficiently.

GRP’s Pharmaceutical Regulatory Strategy Services in South Korea:

  • Identify and the latest regulatory requirements related to your pharmaceuticals, biologics, biosimilars and generics.
  • Proactively identify challenges or issues that may delay the approval of your pharmaceutical 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 pharmaceutical product registered in South Korea.

Product registration

The Korean Ministry of Food and Drug Safety (MFDS), formerly the Korea Food and Drug Administration (KFDA), is the main regulatory body for drug registration and approval.

The Korean Pharmacopoeia (KP) is a pharmaceutical order implemented by the Korean government with regard to the improvement of public health. The KP defines the standard for quality and safety, hence drugs stated by the KP are acknowledged to be safe and efficacious in the treatment and prevention of diseases. The classifications for pharmaceuticals are as follows:

  • Drug products that do not require a safety and efficacy review– Drugs that have already been deemed safe and efficacious or are listed in the Korean and U.S. Pharmacopeia. These drugs only require a MFDS notification submission.
  • Drug products that require a safety and efficacy review, and intensive management– Drugs that require a review and approval to prevent risk factors.

DRUG REGISTRATION PATHWAYS

For new drugs:

  • Submit investigational new drug (IND) application to the MFDS.
  • The MFDS conducts the IND application review.
  • Submit new drug application (NDA) to the MFDS.
  • If the MFDS does not require supplementary data, the NDA is approved.
  • Prepare the application dossier for drug approval.
  • Submit the application to MFDS Management Division for Drug Approval & Review.
  • The MFDS conducts an initial assessment of the application, generates a report outlining the application dossier, and submits it to the MFDS Drug & Evaluation Department.
  • The Drug & Evaluation department conducts a review of the following, including: results of the initial assessment, technology, safety & efficacy data, product standards, clinical trial data, good manufacturing practice (GMP) data, Drug Master File (DMF) data, impacts on intrinsic (genetic) factors, and extrinsic (factors) etc.
  • If no further documentation or supplementary data is required, The MFDS issues the applicant a Certificate of Approval.

For API Products:

Drug Master File (DMF) preparation: The MFDS requires registration of certain substances, which are subject to DMF registration. A DMF will often contain confidential information on facilities, materials, processes, and packaging. By submitting a DMF to the MFDS, the registered manufacturer can then refer importers or distributors to the registration number without disclosing confidential information to Korean business counterparts.

  • Application submission: Applicants who wish to register their API may submit their application via the Korea Drug Master File (KDMF). Foreign manufacturers of these drug substances or products containing these substances can submit a DMF through a Korean importer or third-party representative with a Korean address. Domestic manufacturers can submit a DMF to the MFDS directly.
  • Once a DMF is submitted, the MFDS will review the documents and conduct a facility inspection. Most applications will need to undergo a facility inspection prior to receiving approval.
  • Once the application is approved, the MFDS will send a letter of acceptance and publicize the names of the DMF sponsors and registered substances. The timeframe is approximately 5-6 months, however, can extend to 8-9 months depending on the current capacity of the MFDS.

DOCUMENTS REQUIRED FOR PHARMACEUTICAL REGISTRATION

The application dossier generally includes:

  1. Origin or backgrounds leading up to discovery and development.
  2. Product structure (physical, chemical, biological) nature
  3. Stability test data
  4. Toxicity data
  5. Pharmacologic effects
  6. Clinical data – New products must fulfill the requirements of the MFDS New Drug Application (NDA)
  7. Uses in other countries (if applicable)
  8. Comparison with similar domestic products (if applicable)

 

Regulatory Affairs

Global regulatory Partner, Inc., provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with regulatory authorities.

Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in new markets and maximize the value of their assets.

Regulatory Operations

Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in South Korea.  GRPs dedicated team of experts ensures the quality and validity of the dossier submissions in accordance to the technicalities of regional eCTD requirements.

Global Regulatory Partners Inc. (GRP) Regulatory operation services include consulting services, planning and assembly of submissions, document creation and approval, e-Submission roadmap compliance, publishing, viewing and navigation, archiving, submission process optimization, tracking and lifecycle management.  GRP remains in compliance by implementation of Regulatory Information Management (RIM) with XEVMPD and IDMP requirements.  GRP will facilitate and coordinated management of all paper and electronic submissions, both eCTD and non-eCTD electronic submissions, and ensure timely submissions.

Medical writing

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. As Regulatory authorities expect precise, clear and well-written documents, any bad writing can raise MFDS 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 includes: 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, 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 numerous consultation meeting with the MFDS health authorities.

Clinical

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.

Electronic Filing System (KiFDA)

Korea’s drug clinical trial approval forms can now be submitted through the e-registration system. Applicants and CROs can self-register their products after receiving approval.

GCP Requirements for Conducting Clinical Trials in S. 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 S. Korea are completed, companies should file a report to the MFDS, including all data, therapeutic effects, and adverse events from the trial.

GRP Clinical Trial services for  in South Korea:

  1.  Assess qualification of clinicians, institutions and CROs
  • Evaluate track record of clinicians and institutions for the type of devices to be investigated.
  • Assist in creating awareness of manufacturer’s product with key clinicians and facilitate relationship between clinicians and manufacturer.
  • Regulatory and product compliance requirements.
  • Research IRB and Trial Indemnity requirements.
  1. CRO qualification and selection
  • Thorough pre-qualification of Australian CRO based on needs.
  • Intensive screening of CRO and level of experience, service level, etc. based on manufacturer’s criteria.
  • Intensive one-on-one interviews to determine a “short list” of qualified candidates.
  • Final selection is based on your comfort level and objectives.
  1. Manage Clinical Trials
  • Liaison between your company and your appointed CRO in South Korea.
  • Assistance with troubleshooting.
  • Contact and visit your  CRO to assess progress.
  • Provide the manufacturer with independent reports on patient recruitment, trial progress and issues.
  • Represent the manufacturer in any liaison activities with clinicians or institutions as required

Cosmetics

In South Korea, Cosmetics are regulated by the Ministry of Food and Drug Safety (MFDS) and the Ministry of Health (MOH). Cosmetics sold in the South Korean market must comply with the Cosmetic Enforcement Ordinance, Cosmetic Enforcement Regulations and MFDS Notifica­tions. Cosmetics are defined as “Any item intended to be used by means of spreading, rubbing, spraying on or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or brightening the appearance, or maintaining or improving the health of skin and hair, which have light effects on the human body.” Cosmetics are divided into two categories: Functional Cosmetics and General Cosmetics.  

  • General Cosmetics, are permitted to be manufactured or imported without registration by manufacturers or importers who are registered with the Ministry of Food and Drug Safety (MFDS), and are subject to post-market supervision.
  • Functional Cosmetics, manufacturers and importers are required to undergo an evaluation on safety and efficacy by the MFDS. Approved products require a secondary approval before they can be marketed.

To conduct commercial operations in South Korea, under the cosmetic regulation, an enterprise intending to manufacture cosmetics shall be registered as a “manufacturer” while an enterprise that intends to import cosmetics shall be registered as a “Marketing authorization holder”. Foreign manufacturers that want to import cosmetics products into South Korea need to assign an Authorized Local Agent or In- country Caretaker (ICC) who will handle the products’ registration in South Korea.

Global Regulatory Partners Inc., (GRP) can help your company find the right regulatory pathway for your cosmetics in South Korea. GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and can help you register your Cosmetic product in South Korea.

Related Links:

MFDS. Bio& Cosmetics. https://www.mfds.go.kr/eng/wpge/m_22/de011012l001.do

Authorized local agent

Global Regulatory Partners Inc., (GRP) can help your company find the right regulatory pathway for your cosmetics in South Korea. GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and can help you register your Cosmetic product in South Korea.

RESPONSABILITIES OF ICC

  • An ICC in Korea is responsible for applying to the Ministry of Food and Drug Safety (MFDS) for product approval, making sure that Korean labeling is accurately added to the product, documenting and reporting adverse events or product failures, etc.
  • An ICC can also act as a liaison between the foreign manufacturer and its 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 Cosmetic Services in South Korea:

  • Regulatory intelligence
  • Regulatory Strategy
  • Regulatory affairs
  • Product Registration
  • Cosmetic packaging and labeling review
  • Product classification & Formulation Review

Regulatory intelligence

Cosmetics are regulated the Ministry of Food and Drug Safety (MFDS) and the Ministry of Health (MOH).   some countries require registration of cosmetic products others only require a notification. GRP experts can collect the regulatory and other important requirements applicable to your product such as: registration dossier, claims, prohibited list of ingredients, importation regulations, specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in South Korea’s market.

Regulatory Strategy

Developing the right regulatory strategy for your products in the South Korean Market is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of products and for different markets.

Our strategy will help you meet your business objectives and goals and reduce your risk of failure. In developing the regulatory strategy, our team takes into consideration different factors such as information on your products and similar products on the market, your product development status and milestones, your business goals and timelines, the regulatory requirements related to your product, cost, and risk assessment. With a global presence and a local team of experts, GRP regulatory strategy will give you confidence in the forecast of key milestones, a list of the necessary documentation needed for product development and registration, timelines and cost of the different activities, and action plan to meet your milestones.

Regulatory Affairs

Global regulatory Partner, Inc. provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with MFDS regulatory authorities. Our Regulatory affairs teams help cosmetic companies understand and efficiently manage the demanding and complex MFDS Regulatory requirements for Cosmetics in order to successfully register and commercialize their products in the South Korea’s market.

Cosmetic packaging and labeling review

Global regulatory Partners, Inc. (GRP), provides end-to-end cosmetics packaging and labeling services to enable manufacturers effectively navigate region-specific regulations, manufacture and sale compliant products. GRP’s services include cosmetic packaging and labeling review to ensure that their content is in compliant with local and /or regional requirements and the products can be used safely by consumers. GRP can help by reviewing you cosmetic packaging and labels to make sure it complies with Ministry of Drug and Food Safety (MFDS).

 

Product classification & Formulation Review

Global Regulatory Partners, Inc. (GRP), provides a comprehensive range of Regulatory Services related to the analysis of the list of cosmetic and PCP ingredients, the review of their formulation and labeling Inc. can help by reviewing you cosmetic packaging and labels to make sure it complies with Ministry of Drug and Food Safety (MFDS).

Nutraceuticals

In South Korea, Nutraceuticals are known as Health Functional Food”. They are regulated by

the Minister of Food and Drug Safety (MFDS). Health functional foods are products manufactured (and processed) with functional ingredients or elements useful for human health. “Functional” implies adjustment of nutrients in the human body structure or function, or those that bring useful health effects such as in physiological reaction, etc. Functional ingredients or elements can be categorized into those that are notified/recognized by the Minister of Food and Drug Safety and those that are recognized individually.

According to South Korea health legislation, functional ingredient recognition process includes establishing the foundation for manufacturing excellent health functional foods, (to secure safety and higher quality of health functional foods and to manage the manufacturing and quality of health functional foods in a more structured and systematic way, the ‘Good Manufacturing Practices (GMP) system was prepared and is currently being implemented strengthening  follow-up Management and collection and analysis of abnormal cases.

Global Regulatory Partners, Inc. (GRP) has a team of experts in South Korea who can help Nutraceutical and food supplements companies in South Korea during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by local regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.

Related Links:

MFDS. Biopharmaceuticals and Herbal Medicines Bureau. https://www.mfds.go.kr/eng/wpge/m_22/de011012l001.do

Authorized local agent

Global Regulatory Partners, Inc, (GRP) has a team of experts who helps Nutraceutical and dietary supplements companies worldwide to register and commercialize their products in compliance with local regulatory requirements in terms of labelling , packaging, nutrient content claims and health claims.  Global regulatory Partners, Inc. (GRP) has local offices and strategic partners worldwide that are licensed by local authorities to act as your local agent and can help you register and commercialize your Nutraceuticals and Food Supplements in different markets.

RESPONSABILITIES OF ICC

  • An ICC in Korea is responsible for applying to the Ministry of Food and Drug Safety (MFDS) for product approval, making sure that Korean labeling is accurately added to the product, documenting and reporting adverse events or product failures, etc.
  • An ICC can also act as a liaison between the foreign manufacturer and its 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 Nutraceutical Services in South Korea:

  • Authorized local agent
  • Regulatory intelligence
  • Regulatory strategy
  • Regulatory affairs
  • Product Registration
  • Verification of Nutrient Content Claims
  • Verification of Health Claims

Regulatory intelligence

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.

Regulatory Strategy

Developing the right regulatory strategy for your Nutraceuticals in different markets is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of Nutraceuticals for different markets. GRP strategy will help you meet your business objectives and goals and reduce your risk of failure.

In developing the regulatory strategy, our team takes into consideration different factors such as information on your products and similar products on the South Korean market, your product development status and milestones, your business goals, your timelines, the regulatory requirements related to your product, cost, and risks. With a global presence and a local team of experts, GRP regulatory strategy will help forecast your Nutraceutical launch and commercialization with confidence in South Korea.

Regulatory Affairs

Global regulatory Partner, Inc. provides a full regulatory affairs service from product concept throughout product development till product registration. Our nutraceutical regulatory affairs services in South Korea include regulatory intelligence, regulatory strategy, labeling , packaging, nutrient content claims and health claims.  

Our Regulatory affairs teams help nutraceutical and dietary supplements companies understand and efficiently manage the demanding complexity of the diverse MFDS Regulatory requirements in order to successfully register and commercialize your products in South Korea’s Market.

Verification of Nutrient Content Claims

Nutritional claims are those that state, suggest or imply that a food has some particular- beneficial nutritional properties. This information helps consumers to take an informed decision about whether to purchase and consume the product or not. Nutritional labels and packaging should include information on energy, calories, fats, sugars, proteins and salts. It is important that all this information is accurate and correct, as all nutritional details must comply with the South Korean Regulations.

A nutrient content claim expressly or by implication characterizes the level of a nutrient in a dietary supplement. In addition, MFDS regulations have certain rules governing the provision of voluntary nutrition information, particularly for the front of pack labeling, the nutritional labeling of non-pre-packaged foods and the energy labeling of alcoholic drinks. Some nutrients are now prohibited to be declared in South Korea.

Verification of Health Claims

Health claims are directed to the general population or designated subgroups (e.g., the elderly) and are intended to assist the consumer in maintaining healthful dietary practices.

Global Regulatory Partners Inc. (GRP) team has the expertise in reviewing and validating the health claims that you are making for you nutraceutical products or dietary supplements to make sure that they are supported by scientific data, are accurate and are acceptable to the Ministry of Food and Drug Safety (MFDS).

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