Registration for around 95% of all medical devices is very fast, inexpensive and requires minimal documentation. Note that home country approval is a must with the exception of certain devices (see Concise Regulatory Pathway below).
Medical Device Status
Products that make therapeutic, medical or dental claims are considered Medical Devices in Thailand including aesthetic devices and software as a medical device. Medical Devices with a drug component may be registered as a pharmaceutical.
The current regulatory system groups Medical Devices and IVD devices into three categories, which determines the review pathway for licensing.
Class III, General Medical Device registration requires just a few administrative documents such as a Certificate to Foreign Government / Free Sales Certificate to demonstrate home country approval, a product brochure and an ISO 13485 certificate to apply for registration in Thailand. An Establishment License issued by the Thai FDA of the local registrant and license holder is also required.
Innovative Device Review Process
Certain General Medical Devices that are new to Thailand and do not have a registered predicate in the Thai market can be subject to an Innovative Device Review process. This involves review of selected technical data by an Expert Panel of clinical specialists. The process takes up to 45 working days and carries fees of ThB38,000 (approximately US$1,300). Once the Expert Panel is satisfied, the application is released into the standard General medical device registration process.
General Medical Devices that contain AI software, or a machine learning component are subject to an Efficiency Review. This involves review of selected technical data by an Expert Panel of clinical specialists. The process takes up to 45 working days and carries fees of ThB38,000 (approximately US$1,300). Once the Expert Panel is satisfied, the application is released into the standard General medical device registration process.
Class II, Notified Medical Device registration requires the same administrative documents as General Medical Device registration plus full technical documentation submitted in Common Submission Dossier Template (CSDT) format as per the ASEAN Medical Devices Directive.
Class I, Licensed Medical Device registration requires the same application as Notified Medical Devices plus performance test reports generated from a local, licensed test laboratory.
Products considered Licensed or Notified Medical Devices by the Thai FDA are required to undergo an Expert Review, where the associated fees (listed below) are determined by the device’s ASEAN classification.
THB 25,000 (US$740)
THB 38,000 (US$1,120)
THB 63,000 (US$1850)
THB 88,000 (US$2,590)
Australia – Canada – European Union – Japan – United States
Quality Systems Conformity Assessment
Class I, II and II devices all require ISO 13485 certificates to certify the quality system/s of the legal and/or actual manufacturing facilities.
Validity and Renewal
Licenses are valid through the validity period of the Certificate of Free Sales, up to a maximum of 5 years. Registration Renewals are less expensive than initial registration applications and cost a government fee of $68.
Wireless Technology Licensing
Medical device that contain wireless technology such as cellular, WiFi or Bluetooth are subject to regulatory review by the MBTC. Government review requires 30 to 45 working days and US$200. This licensing is independent from any Thai FDA regulatory requirements, and can be done before, during or after medical device licensing; but must be in place prior to importation.
License Holder Requirements
Import Licenses are issued to a local, licensed company that will own and control the license. Currently, the Thai regulations do not provide for the transfer of licenses between holders. However, foreign manufacturers may have multiple license holders for the same device at the same time.
Benefits of Independent License Holder
Sell directly to multiple regional distributors, avoiding mark-up by a national importer
Increase transfer pricing
Improve leverage in distributor negotiations/responses
Add or change distributors as required
Keep intellectual property away from local commercial agents
Assure expert handling of post market vigilance and license maintenance
It is advisable to consult with a local expert to confirm the regulatory requirements for your specific decides.
Contact Asia Actual with questions or a request for support in Thailand. Asia Actual has a fully licensed offices in Bangkok staffed by experienced, bi-lingual regulatory and commercial professionals to offer medical device registration, independent license holding, importing and sales support services in Thailand.
“The Thai FDA may require an Innovative Device Review for any General Medical device with which it is not familiar. This can add additional time and cost to what is otherwise the fastest registration process in SE Asia.”