Bryan Gilburg - China

“Under the new policy, it will be very important that manufacturers respond to queries timely and completely to avoid the risk of re-submission.”

Bryan Gilburg

Managing Director, Asia Actual

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Thai FDA Announces New Application and Query Response Timelines

Published on: June 10th, 2022

On April 4, 2022, the TFDA updated their application query response policy aimed at expediting target application review times and clearing a backlog of open applications. The new policy also reduces the number of TFDA queries per application and the time applicants have to respond. The guidance also outlines new condition for which the TFDA will reject pending applications and require a new one to be submitted.

Previously, the TFDA would allow multiple rounds of queries per application with up to 30 days for the response. Under the new policy, it will be very important for manufacturers and their local partners to quickly answer questions and submit complete documentation.

This guidance will apply to applications submitted after July 1, 2022. Applications submitted before July 1, 2022 will be given one chance to respond within 30 days.

Below is a table outlining the new query response policies to be implemented July 2022.

Type of application Total review time Response time/Number of revision
Medical device registration 150-300 days

As per announcement on the website: กองควบคุมเครื่องมือแพทย์ Medical – timeline (moph.go.th)

15 days, 1 time
Amendment of the license 7 days (Without Specialist Review)

49 days (With Specialist Review)

2 days, 1 time

5 days, 1 time

Certification for classification 28 days 5 days, 1 time
Advertising registration 45 days 7 days, 1 time

Conditions for TFDA Applications Rejections

The new policy intends to expedite the review process and place more of the burden on the manufacturer and local license holder (Registrant). The TFDA will reject an application if any of the following occurs:

  1. Registrant does not respond within a specified period of time (15 days for applications submitted after July 1, 2022 and 30 days if submitted before).
  2. Registrant responds back with incomplete documents. The registrant will then need to prepare the documents and submit a new application.
  3. The application has a status of “The registrant revises per the attachment” with which the process exceeds 200-300 days, as specified in the Notification of Ministry of Public Health below.
    • Class 1 MD submitted before Nov 12, 2021 and exceeds 200 days
    • Class 2 and 3 MD submitted before Sep 23, 2021 and exceeds 250 days
    • Class 4 MD submitted before Aug 4, 2021 and exceeds 300 days
  4. The TFDA sent inquiries to the registrant before January 1, 2022, but the registrant has yet to respond (applicable from Jun 6, 2022)
  5. Applications that were resubmitted with incomplete documents.

Rejected applications will need to be resubmitted and will need to repay the application fee of THB1,000 (~US$30).

TFDA Official Review Times for New Applications

As the TFDA looks to shorten their review times under the newly implemented regulations, it’s expected that they will begin enforcing these stricter policies to save their staff time. Below are the maximum amount of time the TFDA will take for the various registration routes available depending on the product’s classification.

MD Class Review time

(Working days)

1. Listing
Registration for manufacturing or importation of Listing medical devices (In the case of a medical device that not being 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 being 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
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
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

The total review time is the amount of time from payment of the submission fee until issuance of the license.

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Please contact Asia Actual with any questions or requests for support in Thailand.  We have offices staffed by experienced, bilingual regulatory and commercial professionals in the major capital cities of Asia.  Our mission is to provide a stable, reliable local platform so that our clients can grow their sales in challenging Asian markets.

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