Bryan Gilburg - China

“The new timelines are similar to those posted previously but have reduced review times for Partial applications and those that don’t require Specialist Reviews.”

Bryan Gilburg

Managing Director, Asia Actual

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TFDA Updates Review Timelines for Medical Device Applications

Published on: April 8th, 2022

On April 4, 2022, the Thai FDA released updated review timelines for medical device applications submitted through the e-submission portal. This comes a little over a year after the TFDA implemented their new regulations and provided their initial estimated review times. Now that there has been significant experience reviewing applications, the TFDA has the new timelines to help manufacturers better plan for market access. Additionally, the TFDA has broken out the review timelines to better represent the time it takes for various applications, including those submitted as Partial 2 vs. Full CSDT vs. Full CSDT with a Specialist Review. Previously, the TFDA had only provided the maximum review time per registration route i.e. Listing, Notification or License which included a Specialist Review and a full CSDT review, making the review times seem much longer than they actually were.

Please see our Thailand Medical Device Registration page for more information on the topic.

Updated Review Timelines in Thailand

Medical Device Classification Review Time

(Working days)

1. Listing (Class A)
Eligible devices include those not announced in the Notification of the Ministry of Public Health Re: Specific Devices/Sterile medical devices/Medical devices used for measurement auto approval
Registration for manufacturing or importation of Listing medical devices (In the case of a medical device that are announced in the Notification of the Ministry of Public Health Re: Specific Devices/Sterile medical devices/Medical devices used for measurement) within 200
2. Notification (Class B and C)
Registration for manufacturing or importation of Notified medical devices – In the case where the information or evidence is not required under the Ministerial Regulations regarding Notified medical devices for manufacturing or import registration

(Partial 2*)

within 150
Registration for manufacturing or importation of Notified medical devices – In the event that a specialist/working group/sub-committee review is not required

(Full CSDT)

within 200
Registration for manufacturing or importation of Notified medical devices – In the event that a specialist/working group/sub-committee review is required

(Full CSDT with Specialist Review**)

within 250
3. License (Class D)
Registration for manufacturing or importation of Licensed medical devices – In the case where the information or evidence is not required under the Ministerial Regulations regarding Notified medical devices for manufacturing or import registration

(Partial 2*)

within 200
Registration for manufacturing or importation of Licensed medical devices – In the event that a specialist/working group/sub-committee review is not required

(Full CSDT)

within 250
Registration for manufacturing or importation of Licensed medical devices – In the event that a specialist/working group/sub-committee review is required

(Full CSDT with Specialist Review**)

within 300

* Partial 2 applications are only permitted until the end of 2023, when the transition period will end. It permits some products’ applications to be submitted with less (Partial) CSDT documentation.

** Specialist Reviews are determined at the discretion of the applications reviewer and is more likely among novel devices and applications with lacking documentation. 

Automatic Cancellation System Implemented

Additionally, the TFDA has also implemented a new cancellation system that will automatically cancel applications if they meet certain criteria. This criteria includes applications that require more than 4 corrections or have not been corrected within 30 days from receiving TFDA feedback.  This action will be taken for the applications submitted from February 1, 2022 onwards.

Come Grow with Us

Contact Asia Actual if you’d like to learn how this regulation might affect your sales options in Thailand.

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.

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