regulations of medical devices in thailand
TRANSCRIPT
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REGULATIONS of MEDICAL DEVICES IN THAILAND
Yuwadee Patanawong FDA THAILAND
6 November 2015
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Secretary-General
3 Deputy Secretary Generals
Infra-structure of Food and Drug Administration Committees&Subcom
Import and Export Inspection Bureau
Medical Devices Control Division
Drug Control Bureau
Food Control Bureau
Narcotic Control Bureau
Cosmetic and Hazardous Substances
Control Bureau
Information Technology Center
Public Sector Development Group
Legal Affair Group
Internal Audit Task Group
One Stop Service Center (OSSC)
Complaint & Suppression Center
Technical and Planning Bureau
Public & Consumer Affairs Division Office of the Secretary
Rural and Local Consumer Health Product
Promotion Division
Senior Advisors & Senior Experts
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VALUE
“PROTECT”
• P People Centric
• R Reliability
• O Ongoing Learning
• T Team work
• E Ethic
• C Competency
• T Transparency
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VALUE
“PROTECT”
• P People Centric
• R Reliability
• O Ongoing Learning
• T Team work
• E Ethic
• C Competency
• T Transparency
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Mission
1) Regulate, monitor and promote for the availability of safe and good quality health products.
2) Promote the consumer knowledge, understanding and the correct behavior in consumption of health products.
3) Support entrepreneurs to get more competitive opportunities for further increase value of the national economy.
4) Develop organization management to the excellence
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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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• Before 1988, using Drug Act
• Since May 1988 - Medical Device Act 1988 • 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 2008 *** + Draft Amendment
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 Devices
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 Registration
2. Selling License for announced
medical devices
Premarketing premise approval (1)
1. Establishment Registration:
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• License required Medical Devices
• Notification required Medical
Devices
• General Medical Devices
Premarketing product approval (2)
Medical Devices are controlled into 3 levels:
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Premarketing approval (at present)
1. Licensed medical devices
2. Notified Medical Devices
3. General Medical Devices
Licensing CSDT
Notification CSDT
FDA Cert. for custom process
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General Medical Devices • Devices not on the list of License required medical devices and Notification required medical devices • Majorities are general medical devices
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• Condoms • Surgical Gloves • HIV test kit for diagnosis purpose
• Corrective and Cosmetic Contact Lens
• Blood Bags both empty and containing anticoagulants or additive solutions
• etc
Licensed Medical Devices
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Notified Medical Devices • Physical Therapy Devices • Alcohol Detectors • Silicone Breast Implants • Breast Enhancer External Use devices • Urine Screening Test for Methamphetamine • Ophthalmic Viscoelastic devices • etc
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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 and Suppression Center
in Thai FDA
• All complaint Post-marketing services for all FDA responsible health products
• Post-advertisement control/monitoring
• Suppression and Law enforcement done by Post market team of related health products
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Network of Control (1) • Provincial FDA operated by provincial health offices
• Inspection at FDA port situated among all region and work closely with Custom Department
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Network of Control (2) • Network of Expertise, Health Professional
• Network of Lab/Test Agency and Standard organization
• Network of Consumer Police Agency, etc
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Important Notes (1) Reclassification and Control Level of
Medical Devices based on Risk Factor
•Medical devices (Non IVD)
•IVD devices
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Thai FDA Notification relating to Risk Classification of Medical Devices
• Thai FDA Notification relating to Risk Classification of Non IVD Medical Devices (April 2015)
• Thai FDA Notification relating to Risk Classification of IVD Medical Devices (April 2015)
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Risk Classification of Medical Devices
Annex 2 Non IVD medical devices
Annex 3 IVD medical devices
(16 Rules) Class A Low risk Class B Low-moderate risk Class C Moderate-high risk Class D High risk
(7 Rules) Class A Low Individual Risk and
Low Public Health Risk
Class B Moderate Individual
Risk and/or Low Public Health Risk
Class C High Individual Risk
and/or Moderate Public Health Risk
Class D High Individual Risk and High Public Health Risk
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Premarketing approval Future
1. License required medical devices
2. Notification required Medical Devices
3. Listing Medical Devices
High Risk
Moderate Risk
Low Risk
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RECLASSIFICATION
Licensed medical devices
Notified medical devices
General medical devices
Listing medical devices
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Important Notes (2) National Single Window/ License
per invoice
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Duties of Importers
• Input product database for all
items that are still active or
planned to be sold in Thailand
• Training organized by Thai
FDA has been provided.
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Important Notes (3) ASEAN Medical Device Directive Agreement (AMDD)
Transposition to Law and/or regulations
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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
Implementation of CSDT requirements for license
required medical devices and notification
required medical devices
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Near Implementation
1. Detail requirements for industries on Adverse Events Reporting System
•Information required
•AER Form
•Time frame on reporting
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Near Implementation
2. Detail requirements for industries on FSCA Reporting System
•Information required
•FSCA Form
•Time frame on reporting
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In Process of Drafting and Finalization
Good Distribution Practice (GDP)
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SUMMARY of FUTURE TRENDS/ACTIONS
• Amendment of Medical Device Act 2008 • Upcoming products to be controlled • Drafting new regulations • GDP, Quality Management System Requirements • e-listing of low risk medical devices • Registration of moderate and high risk medical devices
• Roadmaps for implementation and enforcement, etc
•