The Thai Food and Drug Administration (FDA) issued an infographic regarding the guideline for registration of notified medical device for diagnostic test kits and reagents for SARS-CoV-2 (COVID-19). The infographic (in Thai) can be accessed here.
The main idea of this infographic is referred from the Ministry of Public Health Notification RE: Cancellation of Ministry of Public Health Notification Related to Diagnostic Test Kits and Reagents for SARS-CoV-2 (the infectious agent of COVID-19) B.E. 2567 (2024). Highlighted information from the infographic are as follows:
1. For SARS-CoV-2 Registration:
- Must apply to the Notified Medical Device Registration portal.
- Must submit standard testing criteria in various aspects to demonstrate the efficacy and safety of the products. Manufacturers must have evidence showing compliance with relevant international standards such as ISO13485, CLSI, etc.
- Contents on labels and instructions for use must comply with the Ministry of Public Health Notification RE: Rules, Procedures, and Conditions on the display of labels and medical device package inserts, B.E. 2563 (2020).
- No need to submit the technology assessment application.
- No need to test product samples with the laboratory accepted by the Thai Food and Drug Association (TFDA) during registration process
- Cancellation of mandatory measures to sell to hospitals only
2. Proceeding with the registration of notified medical devices for existing registrants:
Local manufacturers or importers who had received technology assessment approval before the effective date of the announcement:
- can continue to produce or import the registered medical devices with approved labels and instructions of use not more than 1 year from the announcement date of this notification (until September 5, 2025).
- can continue to sell the above-mentioned medical devices until their expiry date or until there is an announcement to suspend the sale.
- after September 6, 2025, the technology assessment certificate will expire immediately, and no further production or import can be made.
3. Proceeding with the registration of notified medical devices for new registrants:
New local manufacturers or importers who have never received the technology assessment approval and plan to apply for new registration:
- can prepare documents in CSDT format and submit a new application for the notified medical device registration portal via E-submission due to the cancellation of technology assessment measures.
Note: Any submission of technology assessment being in process or incomplete shall not be considered further. To continue, please submit a new application for notified medical devices portal via E-submission and prepare the CSDT technical dossier thoroughly.
This announcement shall come into force as from the date following the date of its publication in the Government Gazette [Published in the Government Gazette, Vol. 141, Special Issue, Part 244d, page 13, dated on September 6, 2024].
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