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Final Guidance - FAR Submission: Q&A – US FDA
FDA announced the availability of a final guidance for the industry entitled "Field Alert Report (FAR) Submission: Questions and...
Sharan Murugan
Jul 25, 20211 min read
MDCG 2021-14 - Explanatory note on IVDR codes - European Commission
European Commission’s Medical Device Coordination Group (MDCG) released a new document on 13-July-2021, detailing the use of codes under...
Sharan Murugan
Jul 14, 20211 min read
Assessment & Decision Process for the Recognition of a Conformity Assessment Body -IMDRF
International Medical Device Regulators Forum (IMDRF) published a final document describing the “Assessment and Decision Process for the...
Sharan Murugan
Jul 10, 20211 min read
Final Guidance on Unique Device Identification System: Form and Content of the UDI – US FDA
The US Food and Drug Administration (FDA) yesterday (06-July-2021) finalized its guidance on the form and content requirements for unique...
Sharan Murugan
Jul 7, 20211 min read
Latest reforms to Post-Market Monitoring of Medical Devices- Australia’s TGA
A recent notice was published by Australia’s TGA details on the latest reforms to post-market monitoring of medical devices. The TGA...
Sharan Murugan
Jul 7, 20211 min read
Final GMP data integrity guidance– PIC/S
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced that its new guidance on good practices for data management and...
Sharan Murugan
Jul 5, 20211 min read
Draft Guideline on Computerised Systems & Electronic Data in Clinical Trials -EMA
Computerised systems are being increasingly used in clinical research. The complexity of such systems has evolved rapidly during the last...
Sharan Murugan
Jun 26, 20211 min read
Microsoft to Develop Open-Source Software for the Clinical Research Community
On June 1-2021, Clinical Data Interchange Standards Consortium (CDISC) confirmed that CDISC is teaming up with Microsoft to develop the...
Sharan Murugan
Jun 13, 20211 min read
FDA’s New Draft Guidances on Device Postmarket Surveillance – For Comments
The US Food and Drug Administration (FDA) has issued draft guidance to help Medical Device Manufacturers comply with postmarket...
Sharan Murugan
Jun 11, 20211 min read
MDCG offers Guidance on Clinical Investigations – Europe
The European Commission’s Medical Device Coordination Group (MDCG) last week issued guidance providing a set of templates that will be...
Sharan Murugan
May 28, 20211 min read
Reclassification of certain medical devices -Australia-TGA
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019(link is external) were made on 12 December 2019, which...
Sharan Murugan
May 28, 20212 min read
Expectations & Challenges in Conducting Virtual Inspections- USFDA and EMA
Regulators from 11 agencies, representing the US, the UK, Spain, Germany, and Russia, discussed their views on these challenges and...
Sharan Murugan
May 8, 20211 min read
Guideline for Medical Devices Bundling for MAA- Ethiopian Food and Drug Authority (EFDA)
This guideline is intended to provide general criteria for bundling medical devices within one medical device marketing authorization...
Sharan Murugan
May 8, 20211 min read
EU IDMP Implementation Guide - version 2.0
EMA published the current version, version 2.0 (EU IG v2.0), in February 2021. It mainly serves to support the European medicines...
Sharan Murugan
May 3, 20212 min read
Submitting data in the eCTD format - Therapeutic Goods Administration - Australia
This information is for sponsors and manufacturers wanting to submit data in the electronic Common Technical Document (eCTD) format for...
Sharan Murugan
Apr 10, 20211 min read
Submitting data in the NeeS format - Therapeutic Goods Administration -Australia
This information is for sponsors and manufacturers wanting to submit data in the NeeS format for a: prescription medicine biological...
Sharan Murugan
Apr 10, 20211 min read