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REGULATORY REQUIREMENTS FOR
MEDICAL DEVICES IN THAILAND
Yuwadee Patanawong
FDA THALAND
5 November 2012
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Products in Control of Thai FDA
- Food, Drugs, Psychotropic Substances,
Narcotics, Volatile Substances
- Medical Devices
- Cosmetics
- Hazardous substances for household use
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Secretary-General
3 Deputy Secretary Generals
Infra-structure of Food and Drug Administration
Committees
Import and ExportInspection Bureau
Medical DevicesControl Division
Drug Control Bureau
Food Control Bureau
Narcotic Control Bureau
Cosmetic andHazardous Substances
Control Bureau
Information Technology Center
Information Technology Center
National Programon Chemical SafetyNational Programon Chemical Safety
LegalGroupLegalGroup
Internal Audit Task Group
Internal Audit Task Group
OSSC, Enforcement CenterComplaint Center
OSSC, Enforcement CenterComplaint Center
Public Sector Development Group
Public Sector Development Group
Technical and PlanningBureau
Public & Consumer Affairs DivisionOffice of the Secretary
Rural and Local Consumer Health Product
Promotion Division
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THAI FDA VISION
“ Excellent organization to protect public
health and promote the use of health
products which are safe, cost-effective
and in good quality, leading to healthy
society.”
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THAI FDA VALUE
“PROTECT”
• P - People Centric
• R - Reliability
• O - Ongoing Learning
• T - Team work
• E - Ethic
• C - Competency
• T - Transparency
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• Before 1988, using Drug Act
• Since May 1988 - Medical Device Act 1988(effective date: 6 March 2008)
• Medical Device Control Division, Food and Drug Administration was officially established in June 1990 as regulatory authority to control manufacturing, importing, selling and advertising of medical devices in Thailand.
MEDICAL DEVICE ACT IN THAILAND
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• include Medical Devices
For Animal Use
• include IVD products
• include Software
DEFINITION OF MEDICAL DEVICES (1)
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• include accessories, components or parts of medical devices
• include any products announced by the Minister to be medical devices
DEFINITION OF MEDICAL DEVICES (2)
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Conditions to be classified as Medical
Device s
The medical devices must not achieve its
primary intended action in or on the human
or animal body by pharmacological,
immunological or metabolic means, but
which may be assisted in its intended
function by such means.
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• Pre-market approval
• Control at port by FDA inspectors with close relation with custom officers
• Postmarketing surveillance and vigilance
• Advertisement control
• Communication of risk information to the public
CONTROL OF MEDICAL DEVICES
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• Manufacturing Registration• Importing Registration2. Selling License for some medical devices
Premarketing premise approval (1)Premarketing premise approval (1)
1. Establishment Registration:1. Establishment Registration:
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• Licensed Medical Devices
• Notified Medical Devices
• General Medical Devices
Premarketing product approval (2)Premarketing product approval (2)
Medical DeviceMedical Devicess are are cclassified into lassified into 33 ggroupsroups::
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Premarketing approval
1. Licensed medical devices
2. Notified Medical Devices
3. General Medical Devices
Licensing
Notification
FDA Cert. for
custom process
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Post-Marketing Control of Medical Devices• premise regular inspection
• product sampling check, recalling system
• cease production, importation and distribution
• AE reporting and vigilance system
• law enforcement
• public education and awareness
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One Stop Service Center in Thai FDA• Pre-marketing service for all FDA
responsible health products: medical device,
drug, food, cosmetic, hazardous substances
(except narcotic and psychotropic drugs)
• Pre-advertisement approval
• Issuing Certificates, etc
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One Stop Complaint Center in Thai FDA andAdhoc Post-market Team
• Post-marketing service for all FDA responsible
health products
• Post-advertisement control/monitoring
• Law enforcement
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Network of Control• Provincial FDA operated by provincial health
offices
• Inspection at FDA port situated among all region
and work closely with Custom Department
• Network of Expertise, Lab/Test Agency, Standard
organization, Health Professional Associations, etc
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• CondomsCondoms•• Surgical Gloves (Surgical Gloves (being reclassified)being reclassified)•• Examination Gloves (Examination Gloves (being being reclassified)reclassified)•• HIV test kit for diagnosHIV test kit for diagnosisis•• Corrective and CosmeticCorrective and Cosmetic
Contact LensContact Lens
Licensed Medical Devices
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Notified Medical Devices• Physical Therapy Devices
• Alcohol Detectors• Silicone Breast Implants• Breast Enhancer External Use devices
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General Medical Devices• Devices not on the list of Licensed
medical device and Notified medical
device
• Majorities are general medical
devices
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•Ministerial Notification: Requirements on Recording and Reporting of manufacturing/importing/selling of medical devices dated 7 June 2011
Important REGULATIONS Update 2011-2012 (1)
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• Ministerial Regulations and FDA Notifications on Application and Issuing of Manufacturing/Importing Medical Device Products Licenses and Notifications dated 28 May 2012
--- CSDT Requirements
Important REGULATIONS Update2011-2012 (2)
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FUTURE PRIORITY PLANS (1)
Reclassification and Control Level of
Medical Devices based on Risk Factor
•Medical devices (Non IVD)
•IVD devices
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Premarketing approval
1. Licensed medical devices
2. Notified Medical Devices
3. General Medical Devices
High Risk
Moderate Risk
Low Risk
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FUTURE PRIORITY PLANS (2)
National Single Window/ License
per invoice
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Target Thai FDALicense per invoice
Medical Devices
October 2012
December 2012
Target ASEANAll HealthProducts
January 2015
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Custom
Department
Custom
DepartmentThai FDAThai FDA
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ID Number
DatabaseMedical Device
Products
Medical Device
Importers
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Database Importers
Importer (Company) Registration
Number
ID code
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Database Medical Devices (1)
ProductLicense No
ProductNotification
NoFDA Import Permit Letter for General Medical Devices No
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Database Medical Devices (2)
Custom (HS) Code
Product Code
City and Country of Origin/Manufacturers
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Duties of Importers
• input product database for all items that are still active or planned to be sold in Thailand
• pilot implementation
• full scale implementation
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FUTURE PRIORITY PLANS (3)
ASEAN Medical Device Directive
and AEC 2015
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FUTURE PRIORITY PLANS (4)Continue to draft or amend regulations e.g.
• Ministerial Notification No. 34, 19 July 2006 “Medical Devices to be prohibited for import and sale ”
• FDA rule 2007, 28 February 2007 “ Principles on Certification required for import approval of medical devices ”
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FUTURE PRIORITY PLANS (5)
Outsource Program