Standard Registration Process Overview

New medical device regulations were recently implemented in Thailand to harmonize the requirements with the ASEAN MDD. As part of this harmonization, the Thai FDA now requires manufacturers submit Common Submission Dossier Template (CSDT) documentation which includes items such as the Executive Summary, Design Verification and Validation, Clinical Evaluation Report (CER), etc. Manufacturers will also need to show Quality Management System (QMS) compliance by submitting an ISO 13485 certificate.

Class 1 medical device applications require a Listing and are auto-approved upon submission.

Class 2 and 3 medical device applications require a Notification which requires partial or full CSDT documents and an ISO 13485 certificate. The maximum review time set by the Thai FDA under the new medical device regulations is 250 days. New and/or high-tech products may also require a Specialist Review which can take up to 4 months and US$2,600, if selected.

All applications must be submitted by a local entity holding a valid Establishment License, like Asia Actual. More information on the registration process in Thailand can be found here.

Thailand Reliance Route Option

Manufacturers seeking to register a medical device already registered by Singapore’s Health Science Authority (HSA) can now take advantage of the Thailand Reliance Route. The Reliance Route aims to cut the review time down to 60 days, significantly expediting market access for qualifying products.

Manufacturers seeking to expedite their product’s review via the Reliance Route will need to meet with the following criteria:

1. The registration documents in the form of Common Submission Dossier Template (CSDT) that is identical to the CSDT documents used to register with the HSA agency,
2. The change notification documents that are authorized by the HSA agency (if any),
3. The letter to request participation in the Regulatory Reliance Program,
4. The evidence of medical device registration of HSA agency, Singapore.

For more information on the Regulatory Reliance Route, please see our blog on the topic here.