Thailand: Thai FDA Issues Guidelines and conditions for submission of medical device product diagnosis - May, 2018
- 2020-08-06 09:09:52
Large medical equipment is a special type of medical equipment with complex technology, large capital investment and high operation cost, having a great impact on medical expenses. In order to optimize the allocation of large medical equipment in the hospitals,
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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.
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The Council decides to suspend the implementation of Clause 11 of the Medical Device Registration and Management in the Hainan tourism area. In order to support this suspension, CNDA has released a temporary Order, entitled “The Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”. The scope of this Order includes all medical devices that are urgently needed for clinical purposes, operation conditions, and a
MoreThe new medical device rule “MDR 2017, India” has come into effect from January 2018. In line with that, the CDSCO (Central Drug Standard Control Organization) has recently been releasing guidance documents,
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The Malaysian Dental Association (MDA) has organised for an International Dental Exhibition and Conference (MIDEC 2018) to be held soon in Kuala Lumpur. It is a 3 day event being held from 20th July to 22nd July 2018 at the Kuala Lumpur Convention Centre (KLCC) in Kuala Lumpur, Malaysia.
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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.
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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,
MoreHSA 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.
MoreThai 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.
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