• 2026-11-09 04:27:21

Qualtech invites you to join our free webinar on Thursday, November 26, 2026, with the topic "Clinical Evidence Requirements and the Clinical Investigation Landscape to Access the European Market". In collaboration with Spain-based CRO Iberania, our invited regulatory expert and guest speaker will share practical insights into the clinical evidence requirements under the EU MDR and how to best conduct clinical investigations in Europe, so that successful market access and regulatory compliance can be ensured.

• 2022-07-26 09:41:26

The TGA has released version 3.1 of its latest guideline for the clinical evidence for medical devices. The purpose of this guideline is to allow both industry and TGA to support sponsors and manufacturers to collect, compile and present clinical evidence under regulatory requirements as well as to inform on how TGA assesses clinical evidence.

• 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.

• 2020-02-13 06:21:59

Medical devices to be registered in Malaysia must first undergo conformity assessment with a Conformity Assessment Body, to demonstrate its conformity to the requirements of medical device law. In regards to this, currently there are conformity assessment service with good quality and also comparable to global assessments or test carried out by local laboratories.