- Dec 4, 2019
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...
- Aug 30, 2019
North America - Aug 2019
Canada: New fees and performance standards for medical devices effective 1 April 2020 Canada: New medical device incident reporting...
- Aug 30, 2019
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...
- Aug 19, 2019
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...
- Jun 28, 2019
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...
- Jun 28, 2019
Drugs - Jun 2019
China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export...
- Jun 28, 2019
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...
- May 30, 2019
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...
- Mar 29, 2019
North America - Mar 2019
Canada: Non-compliant device labels may now be relabelled/corrected after importation Canada: Priority review process for device...
- Mar 29, 2019
Drugs - Mar 2019
Australia - Procedure for Priority Review / Accelerated Approval China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types...