Medical Device: MFDS Approval

    

Global Regulatory Affairs Consulting Agency, KGMP CORP.

Medical Device: MFDS Approval

Partner with KGMP to ensure your products comply with the regulatory standards of your target market.

KGMP is a trusted leader in medical devices consulting, providing expert guidance to navigate market-specific requirements and ensure compliance with local and global regulations, facilitating safe export and distribution.

Medical Device MFDS Compliance: Essential Insights for Your Business

Navigating MFDS (Ministry of Food and Drug Safety) medical device approval requires a clear understanding of key regulatory pathways, including classification, technical documentation, and KGMP (Korean Good Manufacturing Practice) compliance. We assist in preparing regulatory submissions, ensuring full compliance with MFDS requirements for safety and quality systems. (QSR).

For class II devices, we support technical documentation, while for class III and IV devices, we offer guidance on clinical data, risk management, and on-site inspections, facilitating a smooth approval process. Additionally, we ensure KGMP compliance and tailor submissions to meet MFDS requirements, streamlining the approval process for both initial approvals and renewals.

KGMP Medical Device: MFDS Approval Service

Device classification	Manufacturer or importer license	QMS inspection:KGMP & ISO	Device approval:Technical file

Medical Devices Classification

Medical devices are classified into four risk-based categories (Class I to IV) based on potential risk to human health, harmonized with GHTF/IMDRF rules. 2,109 Medical Device items, excluding IVDD(In-Vitro Diagnostic Devices) and 225 IVDD items are recognized pursuant to ‘Regulations for Product Classification of Medical Device and Class by Product’ and by ‘Regulations for Product Classification of In-Vitro Diagnostic Device and Class by Product'.

[Medical Device (except IVD)]

ㆍClass I (Very Low Risk): Ophthalmic microscope, Radiation shielding glove, Operation table, Stethoscope, etc.

ㆍClass II (Low Risk): MRI, Pulse oximeter, Sterilizer, Electroencephalograph , etc.

ㆍClass III (Moderate Risk): Cryosurgical(mechanical) system, Anaesthesia(gas) system, Silk suture, Condom, etc.

ㆍClass IV (High Risk): Implantable defibrillator, Coronary stent, Biodegradable spine disc, Intraocular lens , etc.

[IVD (In vitro diagnostic)]

ㆍClass I (Very Low Risk): IVD reagents for extracting nucleic acids, Specimen transport media, Blood type(automation) analyzer, etc.

ㆍClass II (Low Risk): IVD reagents for urine chemistry, IVD reagents for vitamin test, IVD reagents for allergy test, etc.

ㆍClass III (Moderate Risk): IVD strip for glucose self test, IVD reagents for infectious disease marker(immunological method), IVD reagents for infectious disease marker(molecular diagnostics), etc.

ㆍClass IV (High Risk): IVD reagents for diagnosis of HIV/HBV/HCV/HTLV(immunological method), IVD reagents for ABO〮RhD blood typing(red cell agglutination), IVD reagents for diagnosis of HVI/HBV/HCV/HTLV(molecular diagnostics), etc.

Manufacturer or importer license

Manufacturer (Factory): KGMP Certificate

Distributor: Manufacturer or Importer License

Product: Medical Device Approval

ㆍ      Class I (Notification)

ㆍ      Class II (Certification, Approval)

ㆍ      Class III, IV (Approval)

QMS inspection: KGMP & ISO

The Korean Good Manufacturing Practice (KGMP) is structured based on the international standard ISO 13485, with modifications tailored to domestic regulatory requirements, ensuring alignment with global quality management standards.

Manufacturers of Class 2, 3, and 4 medical devices are subject to GMP inspections, while Class 1 devices are exempt due to their lower risk. Class 2 devices are primarily inspected by designated third-party assessment bodies, with MFDS involvement when necessary. Class 3 and 4 devices undergo joint inspections by both third-party bodies and MFDS.

New manufacturers must obtain GMP conformity certification before product approval, which may include an on-site inspection. Following the initial certification, GMP renewal inspections are required every three years, with on-site inspections conducted as necessary.

For more details about KGMP: GMP/ISO compliance service ▶ Click here

Medical Device Approval: Technical file

NOTE: The license is valid for 5 years and must be renewed before its expiration.

Remember that different regulations apply in each country.

Contact us today to discover how our medical device label compliance and UDI services can benefit your business.

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