Regulatory Blog

The Philippine Food and Drug Administration (FDA) released an addendum to circular (to FDA Circular No. 2021-002) on the transition to...

Medical Device Coordination Group Document (MDCG) published a guidance (MDCG 2021-19) note integration providing recommendations on how...

The European Medicines Agency (EMA) on 22-July-2021 has adopted a guideline on the quality information that manufacturers of combination...

European Commission’s Medical Device Coordination Group (MDCG) released a new document on 13-July-2021, detailing the use of codes under...

International Medical Device Regulators Forum (IMDRF) published a final document describing the “Assessment and Decision Process for the...

The US Food and Drug Administration (FDA) yesterday (06-July-2021) finalized its guidance on the form and content requirements for unique...

A recent notice was published by Australia’s TGA details on the latest reforms to post-market monitoring of medical devices. The TGA...

eCTD and NeeS are the standard electronic submission formats and allow the Common Technical Document (CTD) structure to be provided in an...

Medical devices encompass a vast array of products with different technologies, product lifecycles, complexity, intended users, and...

The European Commission’s Medical Device Coordination Group (MDCG) last week issued guidance providing a set of templates that will be...

The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019(link is external) were made on 12 December 2019, which...

This guideline is intended to provide general criteria for bundling medical devices within one medical device marketing authorization...