Recently Thai Ministry of Public Health has announced that all listed medical devices must comply with a set of standards, which have been stated in the Announcement.

The listed medical devices are as follow:   

No.

Medical Device

Medical Device Standard

1

Surgical Gloves

Must comply with Ministry of Public Health Announcement (No.31) 2004 regarding Surgical Gloves dated on May 10th, 2004

2

Contact Lens

Must comply with Ministry of Public Health Announcement regarding Contact Lens dated on August 31st, 2010

3

Single-use Sterile Insulin Syringe

Must comply with Ministry of Public Health Announcement regarding Single-use Sterile Insulin Syringe dated on November 25th, 2010

4

Disposable Syringe

Must comply with Ministry of Public Health Announcement regarding Disposable Syringe dated on December 21st, 2010

5

Examination Gloves

Must comply with Ministry of Public Health Announcement regarding Examination Gloves 2012 dated on December 18th, 2012

6

Condom

Must comply with Ministry of Public Health Announcement regarding Condom 2013 dated on September 18th, 2013

7

Ophthalmic Viscosurgical Devices

Must comply with Ministry of Public Health Announcement regarding Ophthalmic Viscosurgical Devices 2014 dated on September 14th, 2014

8

Methamphetamine Urine Drug Test Kits

Must comply with Ministry of Public Health Announcement regarding Methamphetamine Urine Drug Test Kits 2013 dated on September 17th, 2013 and Ministry of Public Health Announcement regarding Methamphetamine Urine Drug Test Kits (N0.2) 2016 dated on September 26th, 2016

9

Blood Bag for Human

Must comply with Ministry of Public Health Announcement regarding Blood Bag for Human dated on March 9th, 2014

10

Dialysate Concentration for Hemodialysis

Must comply with Ministry of Public Health Announcement regarding Dialysate Concentration for Hemodialysis dated on October 3rd, 2017

11

Teeth Whitening

Must comply with Ministry of Public Health Announcement regarding Teeth Whitening 2018 dated on August 17th, 2018

12

HIV Test Kits

Must comply with Ministry of Public Health Announcement regarding HIV Test Kits 2009 dated on November 2nd, 2009 and Ministry of Public Health Announcement regarding HIV Test Kits (No.2) 2019 dated on March 19th, 2019

13

HIV Self-Testing

Must comply with Ministry of Public Health Announcement regarding HIV Self-Testing 2019 dated on March 19th, 2019

14

Contact Lens Care Products

Must comply with Ministry of Public Health Announcement regarding Contact Lens Care Products 2019 dated on April 3rd, 2019

15

Injectable Hyaluronic Acid

Must comply with Ministry of Public Health Announcement regarding Injectable Hyaluronic Acid 2019 dated on August 9th, 2019

16

Products Containing Alcohol for Humans and Animal Sterilization

Must comply with Ministry of Public Health Announcement regarding Products Containing Alcohol for Humans and Animal Sterilization 2019 dated on August 9th, 2019

17

Implanted Silicone Breast Prosthesis

Must comply with Ministry of Public Health Announcement regarding Implanted Silicone Breast Prosthesis 2019 dated on November 7th, 2019

18

Therapeutic Medical Device

Must comply with Ministry of Public Health Announcement regarding the Definition of Medical Device that Manufacturer and Importer must Proceed Medical Device to be Notified Registration 2020 dated on January 31st, 2020

Since COVID-19 (SARS-CoV -2) diagnosis test kits have no Official Announcement that can be referred to at present, manufacturer and importers must comply with the Standards as listed in the table below:

No

Medical Device

Standard

1

COVID-19 (SARS-CoV -2) diagnosis test kit by Real time RT-PCR Methods

Sensitivity, specifications and others as the Secretary of the Food and Drug Administration has announced.

2

COVID-19 (SARS-CoV -2) diagnosis test kit by other Methods from No.19

Sensitivity, specifications and others as the Secretary of the Food and Drug Administration has announced.

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 Standard of Medical Device that Manufacturer or Importer must Comply 2020

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