Thailand: Implementation of New Medical Device Regulations

ARQon
Jul 8, 2021
3 min read

July 08, 2021

The Thai FDA has announced new regulations for medical device registration on 15 February 2021. These new regulations are aligned with the ASEAN Medical Device Directives (AMDD).

Product classification

The Thai FDA has divided medical devices into 3 categories which are Licensed medical device, Notified medical device and Listing medical device.

Figure 1. Thai FDA Classification

List of Submission Documents

The Thai FDA has released the amended information for application form for each classification, although no significant changes have been made. Please refer to the table below for more details.

P-I: Partial 1

P-II: Partial 2

Partial 1: Apply to the Current Importation Certificate which having the expiry date before 15 Feb 2022 only, and the application must be submitted before the certificate will expire.

Partial 2: Apply to the Current Importation Certificate with the expiry date after 15th Feb 2022 and new device submission, and the application

must be submitted within 3 years from the effective date of new laws (15th Feb 2024).

● Mandatory

◊ If applicable

Registration

Existing products will receive U codes after submission and can continue importation. License will be received after FDA review.
New products submission is required for FDA review first (period varying for Listing medical device 200 days, Notified medical device 250 days and Licensed medical device 300 days), before receive license to import product.
Submission groupings Single, Family, System, Set, IVD Test Kit, IVD Cluster will be required.

Revised FDA fee (in baht)

Advertisement New Regulations (Effective since 02 Nov 2020)

Advertisement direct to Healthcare Professionals

No need to submit for pre-approval
Only listing in the Thai FDA system and can implement immediately
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 Regulations (Effective on 31 Oct 2021)

Label & IFU required to be in Thai Language (for home used medical device), and English (for Profession HC).
Information required on label are Thai License no., Name & address of importer, and Contact Info for more inquiry or complaint.
IFU can be electronic form on label (eg. QR code, website or CD ROM).

Adverse Event & Field Safety Corrective Action Reporting (Effective on 05 Feb 2021) 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 leading to AE. Adverse Event, malfunction and FSCA are required to be reported.

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