Overview As one of the fastest growing medical device markets in South-East Asia, Thailand imports major share of its Medical Devices. Thai Food and Drug Administration (TFDA) under Thai Ministry of Public Health (MOPH) regulates the Medical Devices in the country. The agency has risk-based classification of 3 classes of which Class I is for high-risk devices and Class III is for low-risk devices. Identifying the right classification plays key role in the process thereafter. Additionally, with the anticipation of Regulatory revamp by the agency, applicants will have to remain prepared for major changes in the years to follow. Freyr’s experts assist in distinguishing the Device Class and thus to expedite the market approval process. Freyr offers Regulatory assistance encompassing the product lifecycle of Medical Devices and also keeps clients informed about any changes in regulations and prepares them for compliance in time. Thailand Market Entry for Medical Devices - Process Flow Freyr Expertise Medical Device Classification Assistance for Appointing Thai Local Agent Document/Dossier Compilation Post-Market Surveillance Summary S. No Regulatory Parameter Thailand 1 Regulatory Authority Thai Food and Drug Administration (TFDA) 2 Regulation Medical Device Act of 2008 (B.E. 2551) 3 Risk Classification Class I Licensed Medical Devices (High) Class II Notified Medical Devices (Moderate) Class III General Medical Devices (Low) 4 Regulatory Pathway Class I License for sale Class II Notification Class III Validation with TFDA 5 Authorized Representative Taiwan Agent required 6 Fee payable $ 3000 - $6000* 7 QMS Requirement ISO 13485 8 Assessment of Technical Data Medical Device Control Division (MDCD) 9 Validity of License 5 Years 10 Labelling Requirements Section 44, Medical Device Act of 2008 11 Submission format Paper 12 Final Outcome Class I License for sale Class II Notification Class III Certificate for custom process 13 Timelines Class I 8 - 10 Months Class II 6 - 9 Months Class III 7 - 10 Days 14 Language English & Thai *The price is as per records at the time of documentation and is subject to change.