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Thai FDA Fast Track Route for COVID Related Products to Stop
Published on: November 3rd, 2022
The TFDA has announced that the Fast Track registration route for COVID related products will be discontinued from November 4th, 2022 onwards. Previously, COVID related medical products (including surgical masks, face shields, and other products high in-demand early on in the COVID-19 pandemic) were allowed an expedited registration route due to their necessity in medical/public spaces.
Now that this process has ended, these COVID related medical devices are subject to the standard registration process which can take up to 250 days for some Class 3 devices. Previously, the TFDA’s expedited review process had a target review time of 1-2 months.
Products Previously Qualified for Expedited Review
The following products previously qualified for the fast track route temporarily available to products used to help fight COVID-19 during the height of the pandemic.
Class 1 products:
- Surgical Mask
- N95 Mask
- Nasopharyngeal swab, Nasal swab and COVID-19-related specimen collection kit
- Surgical gown
- Isolation gown
- Hair Cover
- Examination glove
- Non-electrical thermometer
- Face shield
- Hood coverings
- Leg cover
- Powered air-purifying respirator: PAPR
- Negative pressure isolation chamber
- Oxygen tank
- Pressure regulator (non-electrical)
- Flow meter (non-electrical)
Class 2 products:
- Electrical Thermometer
- Syringe with needle or needle
- Oxygen concentrator (Home use)
- Flow meter (non-electrical)
Class 3 products:
- High flow nasal canular oxygen (HFNC)
- Pulse oximeter
- UVC sterilizer
- Oxygen concentrator (Point of care)
- Pressure regulator (Electrical)
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:
- 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,
- The change notification documents that are authorized by the HSA agency (if any),
- The letter to request participation in the Regulatory Reliance Program,
- 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.
For more information on the registration process in Thailand, please see our Thailand Medical Device Registration page.
Come Grow with Us
Asia Actual has an office in Singapore and Bangkok staffed by experienced, bilingual regulatory and commercial professionals to address any questions or provide support. Please contact us to explore if this new program is appropriate for your devices.
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.