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. |
References: