• 2020-06-16 06:31:23

Ministry of Public Health Announcement regarding the Standard of Medical Device that Manufacturer or Importer must Comply 2020, is one of the countless Thai FDA Regulatory updates in June. Manufacturer and Importer may refer to this announcement as collection of guidance which standard of listed Medical Device can be denote to.

• 2020-06-16 03:53:06

Thailand Ministry of Public Health’s 2019 Announcement regarding Silicone Breast Implants will be implemented from June 15th, 2020 onwards.

• 2020-06-11 09:53:23

Health Sciences Authority (HSA) strengthens surveillance on different selling platforms to monitor health products with misleading claims to prevent, treat or diagnose COVID-19.; Warnings Issued to Over 1,600 Individual Sellers and Companies. HSA also urges public to be vigilant to report these products.

• 2020-05-12 08:23:22

PFDA reminds the public to buy health products, including medical devices and supplies, only from online sellers with proper authorization/s. In a separate announcement, PFDA released a guidance for manufacturers of PPEs, ventilators and respirators during the COVID-19 pandemic.

• 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.

• 2020-04-14 12:11:36

On March 11, 2020 ThaiFDA announced the revocation of the License holder of 24 Alcohol-Based Hand Sanitizers which does not contain more than 70 % of alcohol by its volume in order to assure the public that Alcohol-Based Hand Sanitizers in the market meet ThaiFDA qualification, containing no less than 70 % of alcohol by its volume.

• 2020-03-16 07:03:45

Ministry of Public Health Announcement regarding Amendment of the Application Form in accordance with the Ministerial Regulations, Specify the Rules, Procedures and Conditions for Registration of Establishment Import License 2019 (No.3) and Registration of Establishment Manufacturing License 2019.

• 2020-02-21 07:22:04

Earlier in January 2020, MDA had released a revised Circular Letter No. 2 Year 2018, on the control of orphaned, obsolete and discontinued medical device healthcare and related facilities. There have been some revisions introduced to the definition of types of medical devices covered in this circular letter.

• 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 07:16:25

In order to maintain the safety and efficacy of a medical device, a surveillance system is needed. Therefore, medical device distributors in Indonesia are recommended to comply with CDAKB / Good Distribution Practice of Medical Device.