Bryan Gilburg - China

“This new process increases the importance of classifying and grouping applications correctly the first time.”

Bryan Gilburg

Managing Director

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Sources and Links

Thai FDA Streamlines Medical Device Registration Process

Published on: March 16th, 2022

Formal Classification and Grouping Guidance Still Available by Separate Process

Starting on March 15, 2022, the Thai FDA will remove the initial pre-submission step from the medical device registration process. Manufacturers, or their local license holders, will now proceed directly with full registration applications through the Thai FDA E-submission system.

By removing the pre-submission step, the TFDA is streamlining the application process for most applications by as much as one month.

The pre-submission process was an initial step where the TFDA would confirm product classification and grouping. New and renewal applicants would submit basic information such as Instructions for Use, product codes, and device labeling and the TFDA would provide feedback within 2 weeks.

For borderline cases, the Thai FDA will still provide formal guidance on classification and/or grouping via E-submission starting April 1, 2022.  Applications come with a 500 THB (US$15) processing fee.  There is not official guidance on processing times, but responses within 2 weeks is expected.

Medical Device Registration Overview

On February 15, 2021, Thailand implemented new medical device regulations to align with the ASEAN Medical Device Directive (AMDD). One of the major changes was adoption of a risk-based classification system. Under the previously regulations, medical devices were divided into three categories not entirely based on risk criteria.  With risk-based categorization of medical device new to applicants and regulators in Thailand, the standard registration process included a pre-assessment step to confirm proper risk categorization and grouping of devices. This pre-assessment step has now been suspended to provide for faster application review and processing.

For the latest information on registering medical devices in Thailand, please see our Thailand Medical Device Registration page.

Come Grow with Us

Asia Actual has offices in Bangkok, and throughout Southeast Asia, staffed by experienced, bilingual regulatory and commercial professionals to address any questions or provide support.  Please contact us if you need regulatory support in the region.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.

Blog Posts

An image of the official logo of India's Government e-Marketplace online portal (also known as GeM)

An Introduction to GeM, India’s Online Portal for All Public Hospital Purchases  

In 2016 the Indian government launched an online portal, the Government e-Marketplace (commonly referred to as GeM) under the Ministry of Commerce and Industry to provide for efficient and transparent procurement by government agencies across the country.
An image of the Vietnam flag above an image of a doctor holding a diagnostic image used for medical treatment.

Vietnam Diagnostic Imaging Center Hosts AI Software Conference

On April 15th the MEDLATEC Diagnostic Imaging Center (MEDIM) hosted a conference to discuss the current state of AI-based software in diagnostic imaging in Vietnam.
A picture of a stack of documents on top of an image of the flag of India

India CDSCO Alerts Manufacturers to Non-Notified Class C and D Deadline

On October 1st 2023, the India CDSCO will enforce full license requirements for Class C and D non-notified medical devices as the final step of transitioning all medical devices under the new rules.