Ministry of Health
Ministry of Public Health – Thailand Food & Drug Administration (Thai FDA)
Regulatory Authority
Medical Devices Control Division (MDCD)
Medical Device Regulation
Official Language
Thai
Classification
Class I, II, III and IV
Registration Process
Documents Required
Applicable QMS
ISO 13485
Registration Timeline
Authorized Representative
Yes
License Validity
5 years
Special Notes
Labels and IFUs should be in Thai and English.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.
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