Tuesday, 21 October 2014

Jang Yong Choi

Medical Device Regulation Overview

MFDS Organization and Responsibilities

Medical Device Regulation Updates

Status of Medical Device Industry in Korea

Contents

Status of Medical Device Industry in Korea

I.

Medical Device Market in Korea

CAGR 5.2%

(US $ Mn)

3,532.54,274.4

4,793.2 4,879.15,142.6

0

1,000

2,000

3,000

4,000

5,000

6,000

2009 2010 2011 2012 2013

size of Medical Device Market in KoreaMarket Volume (US $ Mn)

* 11th market in the worldThe World Medical Markets Fact Book2013, Espicom

Medical Device Market in Korea

(USD MN)

The World Medical Markets Fact Book2013, Espicom

1,5431,780

2,1002,4782,513

2,831 2,855 2,880

2010 2011 2012 2013

Exports Imports

Medical Device Business Entities

(year)

(year)

2009 2010 2011 2012 2013

Manufacturer 2,031 2,168 2,245 2,550 2,711

Importer 1,609 1,626 1,662 1,898 2,027

Total 3,640 3,794 3,907 4,448 4,738

1,000

2,000

3,000

4,000

5,000

Number of Device Business Entities

2009 2010 2011 2012 2013

Notification 3,631 4,341 3,585 3,959 5,362

Approval 2,429 2,666 2,899 4,013 5,817

Total 6,060 7,007 6,484 7,972 11,179

-2,000 4,000 6,000 8,000

10,000 12,000

Product ApprovalNo. of Product approval and notification

MFDS Organization and Responsibilities

II.

Ministry of Food and Drug Safety (MFDS)[former KFDA]

O-Song

Seoul

March 22, 2013

KFDA was promoted to the

Ministry of Food and Drug

Safety(MFDS) Headquartered in O-Song

http://www.mfds.go.kr

http://www.mfds.go.kr/

Organization of MFDS

Total : 1,760 persons

Review technical documents,

(Class 3&4, IVD Reagents)

Six Branch Offices(Medical Product Safety Division)

(Seoul, Busan, Gyeongin, Daegu, Gwangju, Daejeon)

- Class 2 MD Approvals

- GMP Inspection for domestic manufacturing Sites

and overseas sites for class 2 imported MD)

- Post-market surveillance

High-tech medical devicesdivision

Cardiovascular devicesdivision

Orthopedic & Restorative devices division

Dental & Gastroenterologydevices division

In vitro diagnostic device T/F

Medical Device Safety Bureau

NFIDSEMedical Device

EvaluationDepartment

Medical devicePolicy division

Medical deviceManagement

division

Medical deviceQuality division

Organization of MDS Bureau

Other Related Organizations

Legal entity established by Medical Device ActSupports and provide information regarding clinical investigations, standards, safety, training, etc. (established June , 2012)

Medical Device Information & Technology

Assistance Center(MDITAC)

Subsidiary Organization

Test labs for medical devices (14 labs)Medical device

Testing Laboratories

Quality Management System(GMP) audit & issue certificate with MFDS (4 Institutes)

Medical device QMSAudit Institutions

Review of Technical Documents on Class 2 devices (6 Institutes)Technical Document

Review Agency

Hospitals accredited by MFDS for Medical device clinical trials (total 132)

Medical deviceClinical Trial Centers

Collaborating Third-party Organization

Industry association approved by MFDS

Advertisement review, Performance reports, Customs prediction report, Representatives of Medical Device Industry

Korea Medical Device

Industry Association

Medical Device Regulation Overview

III.

Medical Device Regulations

MFDS Guidelines and example

documents on specific requirements

Medical Device Act (MDA)

Enforcement Decree of MDA

Enforcement Regulations of MDA

MFDS Notifications of MDA - Notifications for detailed requirements supporting Act

and Ministerial Regulations

Structure of MFDS Medical Device Regulations

any instrument, machine, contrivance, material or similar article that is

used on human beings or animals either alone or in combination with

other devices and that falls under any of the following Items provided

below.

- Articles used for the purpose of diagnosis, cure, alleviation,

treatment, or prevention of illness;

- Articles used for the purpose of diagnosis, cure or alleviation of

or compensation for an injury or disability;

- Articles used for the purpose of test, replacement, or modification of

the structure or functions [of the body]; or

- Articles used for the purpose of control of conception

Definition of Medical Devices

Classification of Medical Devices

4 classes based on potential risk to human health and purpose of use

Harmonized with GHTF/IMDRF rules

2,206 items are designated by current Ministerial Notification

Risk Based regulation : Classification of medical devices

Overview of Medical Device Regulations

Conception

DevelopmentManufacture

Package

LabelingAdverting Sale Use Disposal

Manufacturer/ ImporterVendor User

Manufacturer/ Importer

Pre-Market Post-Market

• Device Business Licenses

(Manufacturing, Importing, Repairing,

Distributing, Rental Business)

• Product Notification/Approval

- Class I / Class II, III, IV(STED) (MFDS, KS, ISO, IEC, Standards)

- Clinical Investigation Plan Approval

(GCP, ICH-ISO 14155)

• QMS requirements(ISO13485)

• Labeling Requirements

• QMS Requirements

• Labeling requirements

• Review of advertisement

• Tracking and control

• Adverse event & safety alert reporting

• Re-evaluation

• Re-examination

• Recall & removal

• Inspections and audits

Based on life span of a medical device

Overview of Medical Device Regulations

Regulation UpdatesIV.

Submission of Clinical Investigation data

To Clarify MD which require to submit Clinical Investigation Data

MD designated by the Minister : Clinical Investigation data is required

- Minister designates the list of MD for Clinical Data submission

- The list developed by the Working Group composed of the

Industry, Academia, the 3rd Review party and MFDS

as of one year after the promulgation of the MDA Amendment

The IVD reagent Regulatory System

All IVD reagents to be regulated as medical devices

As of Six months after the promulgation of the MDA Amendment

IVD regulated medical devices and pharmaceuticals

- IVDD : a medical device

- Reagents : medical devices or pharmaceutical products

※Some of IVD reagents belong to pharmaceuticals

Regulations on limitation to notification and approval of MD

Recent discussion on controversial chemicals

Regulations on limitation to notification and approval of raw material

and medical devices

-Mercury or asbestos-containing medical devices

International harmonization on STED

STED are required for Class 4 (except IVD reagent)

- enforced as of 2014. Jan. 1

- optional for other Classes

STED : Summary Technical Documentation for demonstrating conformity to the safety and performance of medical devices

: proposed by GHTF(IMDRF) including design verification, risk analysis & manufacturing process regarding safety and performance

Application

Accompanying documents

Accompanying documents

Application

STEDSummary of TD ☞

Approval & QMS Inspection Process

Product ApprovalApplication

Application forQMS conformity Distribution

QMS ConformityAssessment Application

OR

product approval Conformity

QMS Certification before distribution

Distribution

Conformity

①

②

Product ApprovalApplication

Distribution

as of six months after the promulgation of the MDA Amendment

ConformityApproval ApplicationIncludes

QMS ConformityAssessment Application

Approval & QMS Inspection Process

QMS Certification before approval

navante1@ korea.kr