Thailand: Medical Device Regulations Change 2021

Product Classification:

Documents for Product Registration

• General class (CFS + ISO13485) change to Listing, Notified and Licensed

• Notification and Licensed class remain as notified and licensed

Difference between Existing Products and New Products

Each Submission

FDA Fee Changes

Registration – Components and Accessories

• Existing products - must list all accessories into FDA accessory system before transition

• Thai FDA will generate U code for each accessory for clearing customs

• Add into main System in new registration application

Missellaneous

• Existing license can still use until expired and renewal with new process condition

• New license is valid for 5 years

-> renewal as per classification

• Current CSDT submission submit each manufacturing site separately

->can grouping in one submission for various manufacturing sites

• FDA review fee is applied in first submission and exempted when renewal if no new information

Advertisment New Regulations

Advertisement direct to Healthcare Professionals

• Regulation – effective since Nov. 2, 2020

• No need to submit for pre-approval

• Only listing in Thai FDA system and can immediate implement

Exemption for Advertisement submission – only Trade name

• Gimmicks – effective since Nov. 5, 2020

• On back drop, poster, etc. – without any other claims of product features & benefit or motivation for demand

Label & IFU New Regulation (Effective on 31 Oct 2021)

Adverse Event & Field Safety Corrective Action Reporting

• AE occurred outside Thailand can be summarized to report twice a year only.

• AE in Jan-Jun – report within Aug

• AE in Jul-Dec – report within Feb next year

• The template of reporting has not yet announced, need to wait sub-regulation but must know before this August.

• For only event in Thailand need to report AE, malfunction and FSCA as current process.

• AE is only serious adverse event that leads to death, disable or need treatment or surgery to prevent permanent disable, public health hazard or near incident lead to AE.

• Effective Feb 5, 2021

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