• 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,

• 2020-02-14 07:35:54

International Medical Device Regulators Forum (IMDRF) held a meeting in China during March 20 to 22. The current chairman, China FDA, proposed two projects and get the support from all IMDRF members.

• 2020-02-14 07:48:41

The Medical Device Authority (MDA) of Malaysia has organised for a medical device exhibition to be held in Malaysia in April 2018. This event, the Malaysia Medical Device Expo, is an initiative by MDA to bring light to latest innovative technologies and advances of global medical devices, in hopes to provide all its stakeholders a one-stop centre for medical devices solutions.

• 2020-02-14 14:53:03

Malaysian lawmakers take medical device related issues pretty seriously, starting with the introduction of the Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012. A faulty pacemaker or even a leaking catheter are the last things patients need to worry about as they may pose various levels of threat to their lives.

• 2020-02-15 06:19:28

The Medical Device Authority (MDA) is inviting all its customers to participate in a Customer Satisfaction Survey. MDA is always trying to improve quality of service provided to all its customers.

• 2020-02-14 15:25:25

On 13 November 2017, Medical Device Authority (MDA) released the Medical Device (Declaration) Order 2017, which comes into operation on 1st of January, 2018. In this order, the MDA declares “Non-Corrective Contact Lenses”, also commercially known as “Cosmetic Contact Lenses”, as legitimate medical device.

• 2020-02-15 06:42:49

 The 5th ASEAN Medical Device Committee (AMDC) Meeting will be held from October 3 to 5, 2017 in Surabaya, Indonesia, along with its related meetings.