The table below is the collection of the regulatory update in relation to  the use of COVID-19 diagnostic test kit in Thailand.

NO.

Regulations

Description

1

Ministry of Public Health Announcement regarding COVID-19 Diagnostic Test Kit and Solution that Require Technology Evaluation 2020

It is mandatory for COVID-19 kits and solution to proceed through Technology Evaluation, to promote the appropriate use of this medical device.

2

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

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

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

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

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

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.

5

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

SARS-CoV-2 (COVID-19) Diagnostic Test Kit and Solution are exempted under section 6 (18) of the Medical Device Act B.E. 2551.

RECOMMEND READING

TH:  Ministry of Public Health Announce that Manufacturer and Importer must Proceed Medical Device to be Licensed Registration 2020

- TH:  Implementation of Ministry of Public Health’s Announcement regarding Silicone Breast Implants 2019

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

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