US: FDA’s DSCSA Exemptions, Waiver, & Exception
FDA’S Exemptions Granted to Trading Partners The U.S. Food and Drug Administration (US FDA) recently announced broad exemptions under the...
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ARQon
Dec 4, 20191 min read
North America - Nov/Dec 2019
USA: FDA medical device user fees for fiscal year 2020 increase by almost 6% USA: Comments sought on possible exemption of powered...
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ARQon
Aug 30, 20191 min read
North America - Aug 2019
Canada: New fees and performance standards for medical devices effective 1 April 2020 Canada: New medical device incident reporting...
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ARQon
Aug 30, 20191 min read
Drugs - Aug 2019
China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing EU/US : EMA/FDA Analysis Shows High Degree of...
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ARQon
Aug 19, 20192 min read
AAMI/UL 2800 Standard for Medical Device Interoperability recognized by US FDA
The Food and Drug Administration (FDA) has designated an AAMI standard and technical information report (TIR), both published earlier...
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ARQon
Jun 28, 20192 min read
North America - Jun 2019
Canada: Medical device fees increased by 2% from 1 April 2019 Canada: ‘Medical Devices Regulations’ updated to refer to 2016 edition of...
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ARQon
Jun 28, 20191 min read
Drugs - Jun 2019
China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export...
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ARQon
Jun 28, 20191 min read
Q-Submission Program (Q-Sub) by FDA
On 7 May 2019, FDA issued a document, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”. This...
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ARQon
May 30, 20191 min read
US FDA published Finalized List of Accessories Suitable for Class I
On 12 Apr 2019, the US FDA published the "Finalized List of Accessories Suitable for Class I" medical devices document, as required by...
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ARQon
Mar 29, 20192 min read
North America - Mar 2019
Canada: Non-compliant device labels may now be relabelled/corrected after importation Canada: Priority review process for device...
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ARQon
Mar 29, 20191 min read
Drugs - Mar 2019
Australia - Procedure for Priority Review / Accelerated Approval China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types...
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ARQon
Mar 28, 20191 min read
US FDA statement on Evaluation of Materials in Medical Devices
The US FDA released a statement on the topic of materials used in medical devices as part of their effort to address potential safety...
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ARQon
Nov 20, 20181 min read
US FDA releases Modifications to the List of Recognized Standards
The US FDA announced a publication containing modifications made to the list of standards FDA recognizes for use in premarket review (FDA...
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ARQon
Nov 19, 20181 min read
Apple obtains last minute De Novo application approval: Just in time for the Apple Watch 4 reveal
Apple worked closely with the Biologics Consulting Group to attain approval for the De Novo request for their new ECG app on the Apple...
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ARQon
Nov 13, 20182 min read
US FDA introduces cyber-security considerations for Tier 1 & 2 Devices and clarifies CBOM import
For this cyber-security guidance only, FDA introduces the tiers of higher and standard cyber-security risk to aid medical device...
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ARQon
Nov 5, 20182 min read
North America - Dec 2018
Canada: Changes to evidence requirements for Class II and Class III infusion pumps Canada: Applications for medical device...
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ARQon
Nov 5, 20181 min read
Drug - Dec 2018
Australia - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018 Brazil - Questions and Answers: Resolution RDC...
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ARQon
Oct 18, 20182 min read
US FDA Special 510(k) Program Pilot
On October 1, 2018, the FDA launched the Special 510(k) Program Pilot, which aims to expand on the types of changes eligible for the...
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ARQon
Sep 4, 20182 min read
North America - Aug/Sep 2018
Canada: Further reductions to MDSAP audit durations have been announced for small companies Canada: Health Canada is adopting the Global...
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ARQon
Sep 4, 20181 min read
Drugs - Aug/Sep 2018
International - ICH Guidelines Implementation Australia - Medical Devices Safety Update, Volume 6, Number 4, Jul-2018 China - CDE...
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