KFDA & K-GMP

Ministry of Food and Drug Safety (MFDS)

Regulations at Four Hierarchical Orders

Main Task (MEDICAL DEVICES)

Establishment and revision of standards, specifications, notifications, and acts on medical device

·         Establishment of standard for medical devices and promotion of international harmonization

·         Reinforcement of Good Manufacturing Practices (GMP) for medical devices in view of the risk management

Secure safety by enhancing the pre and post management of medical device

·         Notification of information on medical devices

·         Improvement of consistency and predictability of approval and review

·         Establishment of MaPPs to enhance management of approval and review

Operation of the advanced GMP system to establish supply basis of safe medical devices

·         Technical support for GMP review and risk management

·         Expansion of GMP on-site inspection to foreign manufacturers to secure quality of imported medical devices

Reinforcement of safety control system for medical devices distributed in the market to secure its quality

·         Re-evaluation of safety and efficacy of medical devices

·         Reinforcement of adverse reaction management for medical devices

·         Introduction of Good Supply Practice (GSP) for medical devices

Reinforcement of support for industrial competitiveness of medical devices to contribute expansion of national profits

·         Abolition of administrative or procedural regulations irrelevant to safety

·         Support commercialization of new tech medical devices by enacting pre-consultation and vitalizing approval consultant

·         Support for the development of high growth medical devices such as BT·IT·NT fusion and complex, new tech, etc.

Pre-Market Process

Class I -- Notification

Online Submission' for medical devices notification  (No more notification process by documents.)

Class II/III/IV-- Approval

Submit applications to KFDA headquarter

Each model or code number must be submitted

KFDA headquarter review Technical Document Review Application

1.  Package Application: Technical Documents + Application for Product Approval

2.  Sequential Application: Technical documents review + Manufacture/Import Product Approval

Pre-market Applications, Inquires

--Use KFDA-developed, web-based program

--Various forms of documents (pdf, jpg, hwp, word) is acceptable

--Almost every applications can be submitted by website as follows ;

Application for (amended) manufacture/import business license

Application for (amended) product manufacturing/import license

(Amended) product notification

Application for (amended) technical file review

Application for Approval of (amended) clinical investigation plan

Application for designation of clinical investigation institution

Post- Approval Reporting

--Report on clinical investigation

--Adverse event reporting

--Report on Recall(Voluntary/Compulsory)

--Report on safety information

--Report on Re-examination

--Report on Re-evaluation

--Report on amount of production/import

Medical Device Tracking

--Devices implanted in human body for more than one year

--Life-sustaining devices used outside medical institutions

--Including:

Implantable pacemakers /Artificial heart valves/Defibrillators/ Breast implants (silicon gel)

Electrodes for implantable pacemakers or defibrillators/Implantable infusion pumps/rtificial Ventilators

Recall

--Recalling Party - Manufacturer or importer

--Recall Classification

Class 1: Medical devices the use of which causes an incurable serious adverse side effect or death, or is likely to cause it;

Class 2: Medical devices causing or likely to cause temporary or medical adverse side effects which are curable by use of medical devices; and

Class 3: Medical devices not conforming to the standard specifications under Article 18 of the Act, although a violative product is not likely to cause adverse health consequences.

--Submission of recall action plan (to KFDA Headquarter: Class 1, 5 dys; Class 2 & 3, 15 dys :)

Device Business License

--Applications to KFDA Regional Office

--Document requirements

1. Medical certificate of representative of business party issued by physician

2. Corporate register(KFDA verify the status of registered content by government database)

--Device approval or notification required

--GMP/GIP required

KGMP inspections on foreign manufacturers

KFDA inspects foreign manufacturing sites from April 8, 2012. 

Offices for Medical Devices

What We Do?

--Gap analysis audit

--Pre-assessment audit

--Full or partial internal audit

--Subcontractor or supplier audit

--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

Why Jiushun Management?

Jiushun Management, focused on Medical Device Registration, Certification for 20 years, provided high quality service for more than 5,000 global customers.

The MD industry focus degrees, regulatory familiarity, and rich experience, determine our high efficiency and professionalism.

Our professional technical support, from the early regulations, processes guidance, documentation preparation, to testing assistance, review tracking, as well as years of MD industry resource integration, will greatly shorten the period of your product approval, and well practice our principle "Jiushun Management, create value for you. ".