The document provides an overview of Thailand's medical device regulatory process and requirements. It discusses how medical devices are classified based on risk levels and the documentation required for registration. Registration requirements depend on the device's classification, with higher risk devices requiring more documentation. The process involves business registration, product registration or notification, and renewal every five years. It notes the increased costs and documentation under the new risk-based classification system compared to the past.

1. MEDICAL DEVICES:
Update on the Thai FDA Regulatory
Process and Requirements
Atthachai Homhuan, PhD
Director Regulatory Affairs

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4. Outline of Presentation
4
 Overview of the Medical Device Regulations in Thailand
 Important regulatory requirements of medical devices/digital solutions that
the industry should know
 Process of submission (timeframe, key costs, documents)
 Tips for successful registration of a medical device in Thailand

5. Registration of a medical device is similar to
“attempting an uphill task”
5
“Medical Device” means:
A device, an appliance, a mechanical tool, an object inserted into the body, a solution used
for performing a test inside or outside a laboratory, a product, software or any other object
specifically intended by the manufacturer or owner to be used, for any one or more of the
following purposes, on human-beings or animals, whether independently from, in
conjunction with or as an accessory of any other article:
Medical Device Act No. 1 (2008)
and No. 2 (2019)
Key to success: Industry must
understand the regulatory landscape

6. Definition of medical device (continued)
6
1. (a) conducting diagnosis, prevention, monitoring, alleviation or treatment of a disease;
(b) conducting diagnosis, monitoring, treatment, alleviation or treatment of an injury;
. . .
(g) providing information from the examination of body specimens for a medical purpose or for a diagnosis;
(h) performing disinfection or sterilization of medical devices;
2. Supplementary equipment for use in conjunction with a medical device under (1);
3. A device, appliance, mechanical tool, product or any other object prescribed in the Notification of the Minister as a
medical device;
provided that the achievement of the purposes of the articles mentioned under (1) occurring in the human or
animal body must not principally result from:
 a pharmacological or
 an immunological process or
 a metabolic reaction.

7. 7
Thailand: Medical Device VS Drug Product
Simethicone
anti-gas (anti-flatulence)
medication, acting via the change of
the surface tension of gas bubbles
Eyewash solution
Although these products meet the
medical device definition and they are
not acting via:
 a pharmacological or
 an immunological process or
 a metabolic reaction
In Thailand, they are drug products
according to the Drug Act.
Recent Changes in Product Classifications
from drug product to medical device
such as Hyaluronic acid dermal fillers;
contact lens solutions, etc.
Saline Solution

8. For consumer safety,
the product is about
to become a
Medical Device
as announced
by the Minister
Because of the COVID-19
outbreak, the reclassification
of Alcohol-Based Hand
Sanitizer as a medical device
is cancelled.
Alcohol-Based Hand
Sanitizer will continue to
be classified as a
Cosmetic
Alcohol Concentration (Ethanol, Isopropanol, n-Proponol)
of lower than 70 %v/v is now banned in Thailand.
Lotion, Solution, Cream, Gel, Foam, Spray
2018-2019
8
Alcohol-Based Hand Sanitizer
Originally, a product
is either a
Drug or Cosmetic

9. Establishment of Business Place Registration
1
Importer
Domestic Manufacturer
Product Registration/Notification
2
9
FDA Regulatory Landscape and Requirements
Medical Device
• Government fee  THB 16,100
• Approval Timeframe  30 business days
• Renewable (every 5 years)

10. Establishment of Business Place Registration
as an Importer
10
Before importation of a medical device for sale in Thailand, the importer must obtain a business place registration as a medical device
importer.
The importer must:
 Be the owner of the business and have sufficient assets and structure to be able to establish and operate the business;
 Appoint a business operator who is at least 20 years of age and a resident of Thailand;
 Not have been convicted of an offense against certain laws (for example, laws concerning narcotics and psychotropic
substances);
 Have the premises to import or sell medical devices and equipment for use in the storage of devices and the control or
maintenance of the quality and quantity as prescribed in ministerial regulations; and
 Use a trade name for the business that is not a repetition of, or similar to, the trade name used by another active licensee or a
licensee whose license has been suspended or revoked for less than a full year.
After the business place registration license has been obtained, the medical devices must be registered with the Thai Food and Drug
Administration (‘FDA’) prior to being imported/domestically manufactured in Thailand.
The license is valid for 5 years and it is renewable.

11. Medical Device Classification
Medical devices are classified into three (3) categories, i.e.
 Listed (or previously called General) medical devices (low risk, risk class 1);
 Detailed Notification medical device (moderate, moderate to high risk or risk class 2, 3); and
 Licensed medical device (high risk, or risk class 4).
Previously, classifications of each medical device were determined by the Thai FDA, according to
Thailand’s specific circumstances, wherein the classifications of particular medical devices would be
announced in Notifications of the Ministry of Public Health.
Medical devices that pose a high risk or impact the public in the view of the Thai FDA, i.e. HIV test
kits, hyaluronic acid dermal fillers, condoms, prosthetic silicone breast implants, and contact lenses,
etc., were prescribed in the Ministerial Notifications as either Detailed Notification Medical Devices or
Licensed Medical Devices.
Other medical devices that were not prescribed in the Ministerial Notifications would be classified as
General Medical Devices (or Listed Medical Devices). According to the former classification system,
most medical devices in Thailand were classified as Listed Medical Devices.
11

12. Product Registration
2
The registration requirements depend on the category of the medical device, which is
associated with the risk of the medical device.
A Medical Device is classified into three categories according to the Medical Device Act (2008), as amended.
Class 1 Low-Risk
Class 2 Low- to Moderate-Risk
Class 3 Moderate- to High-Risk
Class 4 High-Risk
Listed (General) Medical Device
Detailed Notification
Medical Device
Licensed Medical Device
In the past, the Thai FDA announced particular
devices categorized into the designated
categories above.
Currently, the Medical Device industry must determine the
risk of its medical device independently by referring to the
risk classification system of the ASEAN Medical Device
Directive. Medical Devices are classified into four classes,
depending on the level of risk to individuals and the general
public. For example, Class 4 = Licensed Medical Device.

13. 13
“New Importer” (first time in Thailand)
*CSDT = Common Submission Dossier Template
Burdens for a Medical Device importer/domestic manufacturer
For example, in the past, a Medical Device with a Class 3 risk in another country was designated a General
Medical Device in Thailand. Its registration timeline was about 15 days and required only few documents.
But today, because of the new registration scheme, it is classified as a Detailed Notification Medical Device.
Submission of Renewal Application every 5 years
Submission of
Registration Application
(15 Feb 2021 – 15 Feb 2024)
 Licensed Medical Device (risk 4)
 Detailed Notification Medical Device (risk 2-3)
 Listed Medical Device (risk class 1)
Abbreviated CSDT*
or Full CSDT
for Risk 2-4
Obtain Registration
Approval with
5 years’ validity
Renewal
Submission of Full CSDT* +
Obtain the Renewal Approval

14. 15 FEB 2021
Implementation of Risk
Classification System
15 FEB 2024
 Full CSDT is Required
3 Years Relaxation
Period
Abbreviated Version of CSDT
• Applicable for Licensed Medical Device and Detailed Notification Medical Device
14
“New Importer” (first time in Thailand)

15. Documentation Required for a Listed Medical Device (Class 1)
List of Required Documentation
Normal
Registration
Scheme
Abbreviated CSDT
(Applicable for old
importer only)
Device Description / Product Specification  
Device Labeling/Package Insert  
Manufacturer Information  
Declaration of Conformity (DOC) 
Letter of Authorization for Authorized Representatives  
Commercial Marketing History (if applicable) 
Other Documents, such as descriptions of materials, sterility test
reports (if applicable), calibration test reports (if applicable).
 
15

16. Documentation Required for a Detailed Notification
Medical Device (Class 2 or Class 3)
List of Required Documentation
Normal
Registration
Scheme (Full CSDT)
Abbreviated
CSDT
Executive Summary  
Essential Principles of Safety and Performance of Medical Devices and Method Used to Demonstrate Conformity 
Device Description  
Summary Of Design Verification and Validation Documents 
Device Labeling/Package Insert  
Risk Analysis 
Manufacturer Information  
Disposition And Waste Management 
Quality Management System Certificate (i.e. ISO 13485, ISO 9001, GMP, etc.)  
Declaration of Conformity (DOC)  
Letter of Authorization for Authorized Representatives  
Evidence of Registration Approval obtained in other countries 
Commercial Marketing History 
Declaration Forms related to intended use, label, packing, etc., issued by manufacturer or product owner 
Declaration Forms related to safety of medical device, issued by manufacturer or product owner 
16

17. Documentation Required for a Licensed Medical Device (Class 4)
List of Required Documentation
Normal
Registration
Scheme (Full CSDT)
Abbreviated
CSDT
Executive Summary  
Essential Principles of Safety and Performance of Medical Devices and Method Used to Demonstrate Conformity 
Device Description  
Summary Of Design Verification and Validation Documents 
Device Labeling/Package Insert  
Risk Analysis  
Manufacturer Information  
Disposition And Waste Management 
Quality Management System Certificate (i.e. ISO 13485, ISO 9001, GMP, etc.)  
Declaration of Conformity (DOC)  
Letter of Authorization for Authorized Representatives  
Evidence of Registration Approval obtained in other countries 
Commercial Marketing History 
Declaration Forms related to intended use, label, packing, etc., issued by manufacturer or product owner 
Declaration Forms related to safety of medical device, issued by manufacturer or product owner 
17

18. Detailed Notification
Medical Device
Moderate- to High-Risk (Classes 2-3)
 Time Frame: 160 business days
 Government Fee: THB 49,000 (Class 2)
THB 74,000 (Class 3)
Listing (General)
Medical Device
Low-Risk (Class 1)
 Time Frame: 30 business days
 Government Fee: THB 3,000
Licensed
Medical Device
High-Risk (Class 4)
 Time Frame: 200 business days
 Government Fee: THB 109,000
Previously, almost all Medical Devices in Thailand were classified as Listing Medical Devices. Currently, Medical Device
importers or domestic manufacturers must allocate sufficient budget funds for the registration of their Medical
Devices in Thailand, as the government fees have significantly increased.
Registration Timeline and Government Fees
18

19. 30 business days
The Manufacturer or Importer must
1. Prepare its premises,
equipment, storage
room, as prescribed
by law.
4. Advertisement of a
medical device to the
public must receive prior
approval from the FDA.
3. Post-marketing
Surveillance, product
recall and field safety
corrective action.
2. Submission of dossier with
the FDA. Some medical
devices (e.g., IVD) require
test reports.
19
Tips for the Medical Device industry

20. Digital health in Thailand
20
 Thailand is currently ranked the third most rapidly expanding ageing population in the world
 Talented and skillful physicians/healthcare professionals and world class hospitals
 COVID-19 pandemic
These factors create ideal conditions for digital health solutions in Thailand. There are several Government
programs now available to digital health solution providers.
The idea of “digital health” or “telemedicine” generally falls within the area of Medical Device regulation as
well.
Software and device accessories used for the diagnosis, monitoring, prevention, or treatment of illnesses would
fall under the Medical Device classifications (such as the mobile medical apps, wearable technologies and
software).
Also relevant ate the Personal Data Protection Act (PDPA) 2019 and the National Cyber Security Act 2019 (these
laws involve personal data protection, consent, data control measures, transfer of data, privacy issues, etc.)

21. Dr. Atthachai Homhuan
+66 2056 5610
atthachai.h@tilleke.com