Overview
Thailand is one of the major markets for Medical Device in South East Asia. Medical Devices in Thailand are regulated by the Thailand Food and Drug Administration (TFDA) under the Ministry of Public Health (MOPH), Thailand.
Regulatory Authority: Thai Food and Drug Administration (TFDA)
Regulation: Medical Device Act of 2008 (B.E. 2551)
Authorized Representative: Taiwan Agent required
QMS Requirement: ISO 13485:2016
Assessment of Technical Data: Medical Device Control Division (MDCD)
Validity of License: 5 Years
Labeling Requirements: Section 44, Medical Device Act of 2008
Submission Format: Paper
Language: English & Thai
Thailand Medical Device Classification
The Thai FDA classification system is reverse to that of the US FDA with Class I devices having the highest risk, Class III devices are referred as “general devices”, and Class II referred as “notification”. Additionally, import of used/refurbished equipment is prohibited in Thailand.
Type of Device |
Class |
Risk |
Licensed Medical Devices |
Class I |
High |
Notified Medical Devices |
Class II |
Moderate |
General Medical Devices |
Class III |
Low |
Thailand Legal Representative
For foreign medical device companies that do not want to set up their own subsidiary or trust a local distributor with their product registration information, an independent third party acting as Thai legal agent is the best choice. Employing a Thai third party local agent to register medical products with the TFDA and to act as Thailand Legal Representative allows the manufacturer to easily change distributors.
Thai FDA Medical Device Registration
The Regulation and the registration requirements vary with the type of device. The dossier for Class II and class III devices must be in accordance with a CSDT format.
Licensed Medical Devices such as, condoms, examination gloves, syringes, HIV test kits must show compliance with the Thai Industrial Standards and require license for sale. In certain cases, the devices may have to undergo testing by the TFDA.
Notified Medical Devices such as, physical therapy devices, alcohol detector, implanted Silicone breast prosthesis must obtain product notification by the TFDA.
General Medical Devices account for 90% of the Medical Devices must be validated by the TFDA.
Process flow

Post Approval Device Life Cycle Management
Freyr supports foreign manufacturers in end-to-end Medical Device lifecycle management, including post approval activities, such as:
- Post approval change management - modifications to existing Medical Device approvals such as, addition of new variants, accessories; addition of new indications of use among others
- Maintenance of approvals and registration through timely payment of administrative and registration fees
- Renewal of licenses
- Liaising between the TFDA and the manufacturer
- Importation Management
Freyr as leading Regulatory consultant can assist you through the Thai registration and licensing processes and secure approval for your Medical Device in the shortest possible time frame.
Summary
S.No. |
Device Type |
Class |
Risk |
Registration Pathway |
TFDA Timelines |
Validity |
1. |
Licensed Medical Devices |
Class I |
High |
License for sale |
8 - 10 Months |
5 Years |
2. |
Notified Medical Devices |
Class II |
Moderate |
Notification |
6 - 9 Months |
5 Years |
3. |
General Medical Devices |
Class III |
Low |
Validation with TFDA |
7 - 10 Days |
Depends on validity of FSC |
Freyr Expertise
- Regulatory Due-Diligence
- Regulatory Intelligence (RI)
- Device Classification and grouping
- Notification for Notified Medical Devices
- Registration for Licensed Medical Devices
- Validation services for General Medical Devices
- Legal Representation
- Labeling support
- Translation support
- Distributor identification and qualification
- Post Marketing Surveillance
- Post Approval Change Management