• 2020-02-14 07:30:40

Medical Device Authority (MDA) of Malaysia has made a change in event date of the Malaysia Medical Device Expo 2018. Initially, it was set to take place on 18th to 20th April 2018, however, MDA has very recently made a change for the event to be held from 23rd to 25th October 2018 at PWTC, Kuala Lumpur.

• 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 07:28:51

HSA held a briefing in order to present key proposal changes in the existing regulation. The said event focused on six proposed key changes to current medical device regulations.

• 2020-02-14 07:27:45

Thai FDA announces that they will modify the Medical Device Act and will be adopting the international risk classification method (Class I-IV) in order to comply with the ASEAN Agreement on Medical Device Directive.

• 2020-02-14 04:24:02

Thai FDA published an eye-related product classification checklist guide to help determine whether each product fall under the category of not medical device, medical device, drug, or cosmetic.

• 2020-02-14 04:23:23

TFDA Department of Medical Device and Cosmetics is set to move to a new office starting on April 30, 2018. The new office will be located at the Alley 12, 2nd Section of Yan Jiu Yuan Road, Nangang District, Taipei City.

• 2020-02-14 04:22:39

The ASEAN Medical Device Directive (AMDD) was signed by the ten (10) Member States in 2015, with the main objective of harmonizing the medical device regulations and common technical documents which may help medical manufacturers easily penetrate the ASEAN Medical Device Market.

• 2020-02-14 07:53:58

edtec Japan, Asia’s largest tradeshow dedicated to the design and manufacturing of medical devices will take place from 18 to 20 in April 2018 at Tokyo Big Sight. Qualtech, as a professional medical device regulatory consulting firm in Asia, will participate the event this year to provide regulatory solution for all medical devices to meet the requirement in Asia countries

• 2020-02-14 07:45:46

The Medical Device Authority (MDA) has issued a new Circular Letter on March 5th 2018 bearing new requirements for the licensing and medical device registration for Original Equipment Manufacturer (OEM) in Malaysia. This circular letter identifies who construes as an OEM and the reason why OEMs are not regulated under the Medical Devices Act 2012 (Act 737) till far.

• 2020-02-14 07:43:27

Following a list new regulations and requirements released in March 2018, MDA has issued a new guidance document which specifies requirement on notification for importation and/or supply of medical devices intended solely for the purpose of demonstration for marketing or for the purpose of education.