jang yong choi - astm internationaljang yong choi medical device regulation overview mfds...
TRANSCRIPT
-
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