The Covid-19 pandemic has led to a rapid demand surge in the medical device industry worldwide and every country is stepping up their game to attract foreign device manufacturers and importers who are on a lookout to expand their global market reach. And Thailand is no exception to the rule. Being one of the most crucial markets among the ten ASEAN nations, it is home to about 500 medical device manufacturers and 2500 medical device importers as per the Thailand Food and Drug Administration (TFDA). If you are a new entrant to the Thailand market, you should know that on February 15, 2021, the TFDA issued a new set of guidelines to align its Medical Device Act with the ASEAN Medical Devices Directive. Right from device classification to registration pathways, revised timelines, fee structure and certificate validity, the guidance is effective immediately for all new product registrations. Let us quickly run you through few key changes so that you have a clear understanding of the regulatory requirements.
As per the old regulations, all medical devices in Thailand fell under either ‘General’, Notified’ or ‘Licenced’ category. Since most of them belonged to the General bracket, they involved minimal scrutiny from the regulatory authority. According to the revised TFDA guidelines, all medical devices will now be classified under four classes as opposed to three.
Class I- Low risk, Class II- Low to moderate risk, Class III- Moderate to high-risk, and Class IV medical devices are those that pose the highest levels of risk to human health.
Unlike the previous regulations which allowed grouping for only notified and licenced category of Medical Devices, as per the new rules all classes I, II, III, and IV medical devices and IVDs can be grouped under Single, System, Family, Set, IVD Test Kit and IVD Cluster.
Class I (Low risk) devices- Must be first listed before being imported or placed in the Thailand market for commercial use
Class II & III (Moderate to high risk) devices- Must be first notified before being imported or placed in the Thailand market for commercial purposes
Class IV (Highest risk) devices- Must have an approved licence before being imported or placed in the Thailand market for commercial purposes
The Class II, III and IV devices require submission of technical dossier in accordance with the ASEAN CSDT (Common Submission Dossier Template) format.
Class I Medical Devices: If approved certificates of registered products have less than 1 year of validity beginning 15th February 2021, they must undergo Partial Submission of application for Medical Device Listing. A Class I Listing Certificate is valid for 5 years.
If approved certificates of new as well as registered products have more than 1 year of validity beginning 15th February 2021, they must undergo Full Submission and also require approval from the Thai FDA before importing their products into Thailand territory.
The turnaround time for e-submissions of Class I listing devices is 200 working days.
Class II & III Notified and Class IV Licensed Medical Devices: If approved certificates of Class II, III, IV registered products have less than 1 year of validity beginning 15th February 2021, they must undergo Partial 1 Submission of application. Classes II and III Notified Certificate as well as a Class IV License Certificate is valid for 5 years.
If approved certificates of Class II, III, IV registered products have less than 1 year of validity beginning 15th February 2021, they must undergo Full Submission. However, Partial 2 Submission is allowed for those manufacturers/ importers or distributors who submit their application within the following 3 years beginning 15th February 2021. Also, a formal approval from the Thai FDA is required prior to importation of products into Thailand.
The turnaround time for e-submissions of Class II and III notified devices is 250 working days and Class IV Licence devices is 300 working days.
Besides the changes in the overall registration process including increased timelines, fees and additional documentation, there are few more new regulations to follow suit this year. For instance, the beginning October 31st, 2021, it will be mandatory for every home use medical device sold in the Thailand market to have labelling in Thai. Are you prepared to bear the increased regulatory overload along with escalated cost? At such times, if you do not wish to set up your own subsidiary in Thailand or pick a local distributor to handle your sales because of trust factors, it proves beneficial to appoint a third party legal authorized representative to carry out the regulatory tasks as well as act as a master distributor. Our team of industry experts at Athreva with special focus on emerging markets such as Thailand can help you meander through these tricky terrains and ensure rigorous quality and compliance pre and post-market of your products.
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