Regulatory Blog

Understanding MHRA Guidance on Medical Device Regulations, Regulatory Advice Meetings, and Regulatory Support Medical device manufacturers must navigate a wide range of regulatory requirements throughout the product lifecycle, from development and market access to post-market compliance and safety monitoring. To support stakeholders, the Medicines and Healthcare products Regulatory Agency (MHRA) has published several guidance documents covering medical device regulatory requi

Two notable guidance documents released in 2026 address distinct but equally important aspects of healthcare regulation. The first, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities, provides updated recommendations regarding the communication of healthcare economic and clinical information between manufacturers and healthcare decision-makers. The second, Intent to Exempt Certain Unclassified Medical Devices from Premarket Not

The South African Health Products Regulatory Authority (SAHPRA) has published a new guidance document titled “Guideline for Preparation of a Site Master File (SMF) for Wholesalers of Medical Devices”. The guideline provides requirements for medical device wholesalers preparing a Site Master File (SMF) as part of medical device establishment licence applications in South Africa. The guidance applies to wholesalers of medical devices, including In Vitro Diagnostic medical devic

The Australian Therapeutic Goods Administration (TGA) has updated its guidance on the implementation of the Unique Device Identification (UDI) system for medical devices supplied in Australia. The guidance, Complying with the Unique Device Identification Timeframes for Medical Devices, Version 2.0, published in May 2026, explains the phased UDI compliance timelines, sponsor responsibilities, transitional arrangements, and direct marking obligations for medical devices and IVD