THAILAND: ThaiFDA announces a series of regulations for COVID-19 kit and solution – June 2020
2020-06-16
The table below is the collection of the regulatory update in relation to the use of COVID-19 diagnostic test kit in Thailand.
NO.
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Regulations
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Description
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1
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Ministry of Public Health Announcement regarding COVID-19 Diagnostic Test Kit and Solution that Require Technology Evaluation 2020
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It is mandatory for COVID-19 kits and solution to proceed through Technology Evaluation, to promote the appropriate use of this medical device.
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2
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Ministry of Public Health Announcement regarding Assessor and the Exemption of the Cost of Assessing SARS-CoV-2 (COVID-19) Diagnostic Test Kit and Solution 2020
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Qualification of SARS-CoV-2 diagnostic Test Kits assessor includes personnel from government agency, and other relevant departments.This technology evaluation cost is exempted for 6 months from the announcement’s publications.
|
3
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Ministry of Public Health Announcement regarding COVID-19 Diagnostic Test Kit and Solution that Must be Sold Only to Hospitals or Medical and Public Health Professionals 2020
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Medical devices that must be sold only to Hospitals or Medical and Public Health Professionals are as follows:
1. Ophthalmic Viscosurgical Devices
2. Teeth Whitening
3. HIV Screening Kit
4. Injectable Hyaluronic Acid
5. Implanted Silicone Breast Prosthesis
6. COVID-19 Diagnostic Test Kit and Solution
|
4
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Ministry of Public Health Announcement regarding COVID-19 Diagnostic Test Kit and Solution Labelling and Medical Device Document that must Include Shelf Life Warnings Precautions Contraindications 2020
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Warnings, Precautions and Contraindications as following:
(a) Message “Prohibited of performing personal use” shown in red letter.
(b) Message “Prohibited of public selling” shown in red letter.
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5
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Ministry of Public Health Announcement regarding COVID-19 Diagnostic Test Kit and Solution Exemption under Section 6 (18) of the Medical Device Act B.E. 2551 2020
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SARS-CoV-2 (COVID-19) Diagnostic Test Kit and Solution are exempted under section 6 (18) of the Medical Device Act B.E. 2551.
|
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References:
Ministry of Public Health Announcement regarding COVID-19 Diagnostic Test Kit and Solution that Require Technology Evaluation 2020
Ministry of Public Health Announcement regarding Assessor and the Exemption of the Cost of Assessing SARS-CoV-2 (COVID-19) Diagnostic Test Kit and Solution 2020
Ministry of Public Health Announcement regarding COVID-19 Diagnostic Test Kit and Solution that Must be Sold Only to Hospitals or Medical and Public Health Professionals 2020
Ministry of Public Health Announcement regarding COVID-19 Diagnostic Test Kit and Solution Labelling and Medical Device Document that must Include Shelf Life Warnings Precautions Contraindications 2020
Ministry of Public Health Announcement regarding COVID-19 Diagnostic Test Kit and Solution Exemption under Section 6 (18) of the Medical Device Act B.E. 2551 2020