REGULATORY NEWS & UPDATES

The ARQon Gazette News

      Global Regulatory & Quality Bulletin 
The ARQon Gazette is a compilation of latest updates in the medical device and drug industry. These updates might have an impact to manufacturers and other industry participants.
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July 31, 2016

Health Sciences Authority of Singapore(HSA) recently updated the Guidance documents with clarification on grouping (GN-12-1-R2 and GN-12-2-R2) and the class A exemption notification (GN-22-6.2).

For the Special Access route under GN 26 and GN 27 SAR for qualified practi...

July 31, 2016

Health Science Authority (HSA) will be rolling out a new Singapore Standard(SS) as early as November 2016. This new guidance will be replacing the current Technical Specification(TS-01) albeit manufacturers and industry participants alike will be given adequate transit...

July 31, 2016

Closer to home, the Malaysian government recently announced the exemption of all types of Class A (lowest-risk) devices from conformity assessment requirements hence making it easier for companies to bring such products to the market. This is great news to manufacturer...

July 31, 2016

Meanwhile in Philippines, Food and Drug Administration Philippines (FDA) has come out with a Draft for New Schedule of Fees and Charges of FDA on Licensing, Registration and other Certification. The rationale for the revision of fees is because of the income retention...

July 31, 2016

In Vietnam, on 15 May 2016, the Vietnamese Government issued Decree No. 36/2016/ND-CP on medical device management. The Decree took effect on 1 July 2016. According to the new Decree, foreign medical devices no longer require import licenses but must be registered with...

July 31, 2016

China Food and Drug Administration (CFDA) and National Health and Family Planning Commission of China (NHFPC) have jointly issued the Good Clinical Practice for medical devices (CFDA Order No. 2) in order to further strengthen the supervision and management of clinical...

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