• 2020-02-12 14:01:43

In early November, CMDE has published a draft guideline for the reprocessing validation and labeling for reusable medical devices: Part 1 (hereinafter referred to as the "Guidelines") which solicited opinions from the public.

• 2020-02-12 14:25:26

At the end of September 2018, Medical Device Authority (MDA) had introduced two search engines/databases for the public-use. On a first glance, they look similar to the medical device database of Singapore HSA’s Singapore Medical Device Register (SMDR) but the working mechanism and output are different.

• 2020-02-12 14:16:42

• 2020-02-12 15:00:06

Slight revision on guidance documents about Singapore Standards and Medical devices for exhibition were added last July 2018.

• 2020-02-13 06:02:57

It has been earlier established that Medical Device Authority (MDA) and National Pharmaceutical Regulatory Agency (NPRA) of Malaysia will start to regulate drug-medical device and medical device-drug combination products together, starting July 1st, 2019.

• 2020-02-13 06:02:01

Medical Device Authority (MDA) is constantly trying to enhance the quality of service provided to all its customers. In line with this, MDA is currently conducting a customer satisfaction survey where all kinds of feedback are welcomed to help MDA constantly improve its output in the future.

• 2020-02-14 03:52:53

China National Drug Administration (CNDA) (formerly known as CFDA) has issued a new policy for Hong Kong medical device manufacturers to enter Mainland China market. CNDA can now accept Certificate of Listing and Certificate to CNDA as marketing approval and Quality Management System certificates which are the necessary documents for medical device registration in China.

• 2020-02-14 04:09:43

MDA has released a new regulatory update, pertaining to Licensing Conditions for All Licensed Establishments under the Medical Device Authority in Malaysia. There have been some critical inclusions to the licensing requirements for all licensed establishments in MDA.

• 2020-02-14 07:33:20

In order to support the development of medical devices urgently needed for clinical purposes (hereinafter referred to as "emergency devices"), such as “for life-threatening cases, or diseases that may endanger public health, CMDE has released a draft of the basic principles of medical devices urgently needed in clinical purposes that may be conditionally approved to accelerate medical device listing.

• 2020-02-14 07:29:47

Medical Device Authority (MDA), Malaysia has recently introduced a new initiative calling for e-mail notification subscription by all interested stakeholders. This new initiative by MDA aims to provide the latest information to stakeholders and general public who wish to subscribe to this service,