• 2020-03-18 10:32:08

The ASEAN Common Submission Dossier Template (CSDT) makes it significantly easier to penetrate the ASEAN markets collectively. Therefore, do not miss the chance to learn about the benefits of the CSDT and what documentations are required for developing the Common Submission Dossiers.

• 2020-03-18 10:27:44

Seeking for Local Qualified Distributor? Let Qualtech Assist YOU!

• 2020-03-18 08:59:24

The halal market is promised with billion opportunities. In this article, we will guide you through the market potential of halal products in Indonesia and Malaysia as well as regulatory standard of halal medical device, to give you insights of how to seize the chance to expand your business.

• 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.

• 2020-03-16 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 06:50:01

Medical Devices (Amendment) Rules, 2020 has been newly issued to amend the Medical Devices Rules, 2017. Medical Devices (Amendment) Rules, 2020 will be effective 1st April 2020. All medical devices in India is now to be regulated as “drugs”.

• 2020-03-16 06:48:29

Medical Devices (Amendment) Rules, 2020 has been newly issued to amend the Medical Devices Rules, 2017, effective 1st April 2020. All medical devices in India is now to be regulated as “drugs”.

• 2020-03-16 06:46:58

It is Qualtech priority to deliver the most update and accurate news to our clients as well as performing as platform to all associated organization. OMETA is one of the organizations that has a lengthy association with Qualtech Corporation.

• 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.