• 2020-05-06 09:07:05

In the recent years, CMDE has started to adjust the internal workflow to optimize the registration process. In 2015, they have changed the structure of the reviewing department. This time, they have set up two different departments for a faster operation.

• 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 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.

• 2020-02-14 04:00:29

In order to enhance the requirements for clinical trial approval for non-active implantable medical devices, CNDA has issued “the Guidelines for the Submission Documents of Clinical Trial Application for Non-active Implantable Medical Devices” (hereinafter referred to as the Guideline) in June.

• 2020-02-14 03:59:43

In early June, CNDA had issued a draft consisting of the fourth batch of medical device catalogues to be exempted from clinical trials along with the revisions of the first three batches of catalogues, in able to catch up with the upcoming classification to be implemented in July. In this regard, CNDA is currently accepting comments from the public until the end of June 2018.

• 2020-02-14 03:57:58

CNDA welcomes public comments on the recently drafted policy entitled, "Principles of the Clinical Trial Inspection for Medical Devices", hereby referred to as "Principle".

• 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.

• 2020-02-14 04:17:02

In order to optimize the efficiency of approval process, China Drug Administration (CNDA) has proposed amendments for submission documents for the renewal and clinical trial application of medical devices. This notice was issued at the end of May.