• 2020-05-06 05:54:02

Qualtech is extending its service range and adds yet another country to its service list. Full assistance regarding Thailand medical device registration, local representation, and importation is now offered to our current and potential clients.

• 2020-05-06 05:18:20

The draft guidance on labeling is catered to provide a comprehensive information on medical device and IVD use among patients and/or end-users. The Guidance is expected to take effect after 15 days following its official publication.

• 2020-05-06 05:10:35

In a recently issued revised guideline on How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737), MDA specified that it can drop an ongoing application from MeDC@St system if it exceeds a 90 days stop-clock-time and any new applications which do not conform to requirements specified will be rejected, non-refundable.

• 2020-05-06 05:08:37

MDA has reminded all stakeholders that it is unlawful to market unregistered medical devices with no clinical evidence in Malaysia. In a latest announcement, MDA advises the general public not to believe and be affected by advertisements which contain claims made on this type of devices.

• 2020-05-06 03:45:58

MDA has issued a new guidance document on notification of medical device for special access. A draft for this guidance document was issued earlier this year and based on public comments and suggestion, some changes have been made in the official release document.

• 2020-05-06 03:06:32

MDA has launched a new web-portal, replacing the old one and a new Feedback Management System (FEMES). These new web-portal and FEMES system have been introduced to provide better information delivery and take note of customer feedbacks more effectively.

• 2020-05-06 02:40:59

MDA is organizing the MyMEDEX exhibition for a second time and International Medical Device Conference 2019 from 15th to 17th October 2019, at the Malaysia International Trade & Exhibition Centre (MITEC).

• 2020-05-06 02:39:19

Pharmaceutical drugs in India will from now on abide by the newly notified “New Drugs and Clinical Trials Rules, 2019”. These Rules have been issued in hopes that the rules will increase and improve clinical research in India, which hosts only 1.2% of the world’s clinical trials despite having a high burden of disease.

• 2020-05-06 01:48:16

Pharmaceutical drugs in India will now on abide by the newly notified “New Drugs and Clinical Trials Rules, 2019”. These Rules have been issued in hopes that the rules will increase and improve clinical research in India, which hosts only 1.2% of the world’s clinical trials despite having a high burden of disease.

• 2020-05-06 01:40:30

CMDE has made the necessary adjustments to pave way for a faster process in obtaining clinical trial approval. Prior to these changes, the applicant shall wait for CMDE’s go signal before starting the clinical trial procedure. With this change, the applicant may already start conducting the clinical trial, given some conditions.