FDA’S Exemptions Granted to Trading Partners The U.S. Food and Drug Administration (US FDA) recently announced broad exemptions under the...

USA: FDA medical device user fees for fiscal year 2020 increase by almost 6% USA: Comments sought on possible exemption of powered...

Canada: New fees and performance standards for medical devices effective 1 April 2020 Canada: New medical device incident reporting...

China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing EU/US : EMA/FDA Analysis Shows High Degree of...

The Food and Drug Administration (FDA) has designated an AAMI standard and technical information report (TIR), both published earlier...

Canada: Medical device fees increased by 2% from 1 April 2019 Canada: ‘Medical Devices Regulations’ updated to refer to 2016 edition of...

China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export...

On 7 May 2019, FDA issued a document, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”. This...

On 12 Apr 2019, the US FDA published the "Finalized List of Accessories Suitable for Class I" medical devices document, as required by...

Canada: Non-compliant device labels may now be relabelled/corrected after importation Canada: Priority review process for device...

Australia - Procedure for Priority Review / Accelerated Approval China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types...

The US FDA released a statement on the topic of materials used in medical devices as part of their effort to address potential safety...

The US FDA announced a publication containing modifications made to the list of standards FDA recognizes for use in premarket review (FDA...

Apple worked closely with the Biologics Consulting Group to attain approval for the De Novo request for their new ECG app on the Apple...

For this cyber-security guidance only, FDA introduces the tiers of higher and standard cyber-security risk to aid medical device...

Canada: Changes to evidence requirements for Class II and Class III infusion pumps Canada: Applications for medical device...

Australia - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018 Brazil - Questions and Answers: Resolution RDC...

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...

Canada: Further reductions to MDSAP audit durations have been announced for small companies Canada: Health Canada is adopting the Global...

International - ICH Guidelines Implementation Australia - Medical Devices Safety Update, Volume 6, Number 4, Jul-2018 China - CDE...