Thailand: Cancellation of the Announcement Related to the Diagnostic Test Kits and Reagents for SARS-CoV-2 B.E. 2567 (2024)

To ensure that the control measure of medical devices is appropriate to the current situation and in line with the development of medical technology, it is expedient to cancel the announcements from the Ministry of Public Health related to medical devices for the detection of SARS-CoV-2 (COVID-19). Therefore, the Minister of Public Health, upon recommendation of the Board of Medical Devices, issues the following announcements:

• The following regulations shall be repealed:

1. Ministry of Public Health Notification, RE: Medical Devices Requiring Technology Assessment B.E. 2563 (2020), dated April 27, 2020.
2. Ministry of Public Health Notification, RE: Exempted Medical Devices under Section 6 (18) of the Medical Device Act B.E. 2551 (2008), B.E. 2563 (2020), dated April 27, 2020.
3. Ministry of Public Health Notification, RE: Criteria of Evaluators and Fee Waiver for Technology Assessment of the Diagnostic Test Kits and Reagents for SARS-CoV-2 (the infectious agent of COVID-19) B.E. 2563 (2020), dated April 27, 2020.
4. Ministry of Public Health Notification, RE: Rates, Payment Methods, and Expenses for Technology Assessment of the Diagnostic Test Kits and Reagents for SARS-CoV-2 (the infectious agent of COVID-19) B.E. 2564 (2021), dated February 25, 2021.
5. Ministry of Public Health Notification, RE: Diagnostic Test Kits and Reagents for SARS-CoV-2 (the infectious agent of COVID-19) Type: Self-Test Antigen Test Kits (COVID-19 Antigen test self-test kits) B.E. 2564 (2021), dated July 12, 2021.
6. Ministry of Public Health Notification, RE: Diagnostic Test Kits and Reagents for SARS-CoV-2 (the infectious agent of COVID-19) Type: Self-Test Antigen Test Kits (COVID-19 Antigen test self-test kits) (No. 2) B.E. 2564 (2021), dated September 29, 2021

• Local manufacturers or importers who had received certificates of technology assessment for medical devices before the effective date of this announcement can continue to produce or import by using labels and Instruction For Use (IFU) accompanying previously approved medical devices for up to one (1) year from the effective date of this announcement, with exemption from compliance with Sections 19, 20, 30, 31, and 32 of the Medical Device Act B.E. 2551 (2008) and its amendments, only in relation to the ministerial regulations on the Application for, and the Issuance of Manufactured or Imported Notified Medical Device B.E. 2563 (2020).
• Local manufacturers or importers of the above-mentioned medical devices shall be able to sell their medical devices until their expiry date or until there is a command to cease distribution.
• Those who have submitted applications and are in the process of technology assessment for medical devices before the effective date of this announcement, are allowed to grant to apply the supporting documents of technology assessment application, specifically those not conflicting with or contradicting the ministerial regulations on the Application for, and the Issuance of Manufactured or Imported Notified Medical Device B.E. 2563 (2020), to be submitted as information, documents, or evidence to support the application for notified medical device registration, and shall submit additional information, documents, or evidence to comply with the ministerial regulations on the Application for, and the Issuance of Manufactured or Imported Notified Medical Device B.E. 2563 (2020).

Further information can be accessed here (in Thai).

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