• 2020-05-12 08:17:52

Future regulation follows Risk- based Classification, while current regulation follows Policy- based Classification. Ministry of Public Health Announcement regarding the Definition of Medical Device that Manufacturer and Importer must Proceed Medical Device to be Licensed Registration 2020, in order to gradually promote the transition of Thailand future regulation implementation.

• 2020-05-12 06:28:19

Although Thailand has decreased the numbers of infections significantly yet to relieve since the disease is very contagious. Food and Drug Administration is decidedly in concern that Thailand shall have enough resources in hands to dispute this COVID-19 Outbreak via the Fast Track option developed by ThaiFDA for manufacturer and importer of COVID-19 related products.

• 2020-03-16 07:02:46

ThaiFDA has decisively made an announcement by Ministry of Public Health Announcement regarding Cleaning Products Containing Alcohol as a Component for Hygienic Use 2019 and Ministry of Public Health Announcement regarding Cleaning Products Containing Alcohol as a Component for Hygienic Use 2019.

• 2020-03-16 06:42:41

The Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP),the trial will last until 31 December 2020 for a limited number of listing applications of Class II/III/IV general medical devices. 

• 2020-03-16 06:38:53

Ministry of Health has issued a Circular letter number HK.02.02 / VI / 1465/2019 about withdrawal and elimination of medical devices that contain mercury from the market. This circular letter is addressed to Head of medical devices manufacturer and Head of medical device distributor in throughout Indonesia. They need to take several actions to help the withdrawal and elimination process of medical devices that contain mercury.

• 2020-02-21 07:27:21

January 8th, 2020 has marked the day of Qualtech’s extensive workshop on the new European Medical Device Regulations (MDR) for its Taiwanese clients. The event provided its attendees with the latest updates on the MDR implementation before the end of the transition period on May 26, 2020.

• 2020-02-21 07:20:48

The Ministry of Health (MoH) was recently notified by the MDA on a 'headphone' device that allegedly reduces and controls blood sugar levels, published through a local newspaper.

• 2020-02-21 07:09:30

The Taiwan Council passed the draft of the " Regulations of Medical Devices" (hereafter simply referred to as the “Regulation”) in December 2019. The regulation has medical devices to be legislated independently and thus no longer fall under the Pharmaceutical Affairs Act.

• 2020-02-21 07:06:15

“Essential Regulatory Requirements for Medical Device Approval” Seminar by The Medical Products Consortium of Thailand: MPCT on 27-28 February 2020 is being hosted for the first time in Thailand aiming to promote research develop medical device innovation through the certification assessment process of The Food and Drug Administration Medicine accordingly to international guidelines.

• 2020-02-21 07:04:40

Thai FDA clarifies 3 types of classification of non-in vitro medical device, Licensed medical device, Notified medical device, and General medical device regarding risk assessment. And for In-vitro medical device, the product is classified from class 1 to class 4.