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Compliance deadline for Commercially Reprocessed Medical Device to be extended
According to Health Canada, the Canadian medical device market regulator is planning to extend the deadline for commercially reprocessed...

ARQon
Aug 1, 20161 min read
Transition Plan for the Medical Device Single Audit Program (MDSAP)
Health Canada is preparing the process of adopting the Medical Device Single Audit Program (MDSAP) in place of the current Canadian...

ARQon
Aug 1, 20161 min read
Using IEC 60601-1-9 as a Competitive Advantage
Download this white paper to learn how IEC 60601-1-9 can be used to promote sustainability claims for your medical devices including:...

ARQon
Aug 1, 20161 min read
Medical Device Regulation Finally Published
The consolidated final draft of the new Medical Device Regulation (MDR) has recently been published. The new regulation shall replace the...

ARQon
Aug 1, 20161 min read
Israeli medical technology incubator in Singapore will be managed by a Singaporean
Israeli investment company Trendlines Ltd. has announced that it is founding a medical technology incubator in Singapore. Trendlines...

ARQon
Jul 31, 20161 min read
Updates by HSA on Guidance documents with clarification on grouping
Health Sciences Authority of Singapore(HSA) recently updated the Guidance documents with clarification on grouping (GN-12-1-R2 and...

ARQon
Jul 31, 20161 min read
New Singapore Standard will be replacing the current Technical Guidance by the end of the year
Health Science Authority (HSA) will be rolling out a new Singapore Standard(SS) as early as November 2016. This new guidance will be...

ARQon
Jul 31, 20161 min read
Malaysia makes do without conformity assessment requirement for all Class A devices
Closer to home, the Malaysian government recently announced the exemption of all types of Class A (lowest-risk) devices from conformity...

ARQon
Jul 31, 20161 min read
Revision of fees will be prescribed on all Licensing, Registration and other Certification
Meanwhile in Philippines, Food and Drug Administration Philippines (FDA) has come out with a Draft for New Schedule of Fees and Charges...

ARQon
Jul 31, 20161 min read
Cessation of import licenses for all foreign medical device
In Vietnam, on 15 May 2016, the Vietnamese Government issued Decree No. 36/2016/ND-CP on medical device management. The Decree took...

ARQon
Jul 31, 20161 min read
Increase in supervision and management of clinical trials for medical device in China
China Food and Drug Administration (CFDA) and National Health and Family Planning Commission of China (NHFPC) have jointly issued the...

ARQon
Jul 31, 20161 min read
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