Medical Device Blog

Amazon product claims must be accurate, supported and aligned with the correct product category. AF Pharma helps sellers review listings, labels, images and claims to reduce regulatory risks and support compliant EU and UK market access.

Foreign medical device manufacturers need an Australian Sponsor to access the Australian market. AF Pharma supports TGA strategy, ARTG inclusion, documentation review, labelling, post-market obligations and Australia market access.

Learn what a cosmetic Product Information File (PIF) must include under EU Regulation 1223/2009, including CPSR, GMP, label review, INCI, claims substantiation and CPNP support. AF Pharma helps cosmetic brands prepare compliant PIFs for EU market access.

Product labels are critical for Amazon compliance in the EU and UK. AF Pharma supports sellers with label review, warnings, traceability, claims checks, GPSR compliance and product documentation to reduce listing, customs and regulatory risks.

Medical device manufacturers entering the U.S. need FDA classification, registration strategy, U.S. Agent support and possibly 510(k), De Novo or PMA planning. AF Pharma supports FDA market access and U.S. Agent services.

Learn how to place cosmetic products on the EU market under Regulation (EC) No 1223/2009, including EU Responsible Person, PIF, CPSR, CPNP notification, label review, INCI compliance and cosmetovigilance. AF Pharma supports cosmetic brands with EU market access and regulatory compliance.

UK sellers must ensure their products meet UK safety, labelling, documentation and claims requirements. AF Pharma helps brands review product compliance, labels, warnings, technical documents and market access strategy for the UK.

Entering the Great Britain medical device market requires careful navigation of regulatory requirements. Medical devices must meet UK medical device compliance rules and be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) where applicable. For foreign manufacturers, appointing a UK Responsible Person (UKRP) is mandatory to ensure smooth market access and ongoing compliance. This post explains the key elements of UK medical device registration, th

The new General Product Safety Regulation (GPSR), officially known as Regulation EU 2023/988, introduces updated requirements that will affect all consumer products sold in the EU starting from 13 December 2024.

Amazon EU sellers must comply with GPSR requirements for product safety, traceability, labelling and EU Responsible Person obligations. AF Pharma supports Amazon sellers with GPSR compliance, documentation review, label checks and EU market access.

Learn how foreign medical device manufacturers can access the EU market under MDR 2017/745, including CE marking, technical documentation, clinical evaluation, PMS, labelling and EU Authorised Representative support from AF Pharma.

Entering the UK medical device market requires more than just a quality product. For foreign medical device manufacturers, understanding and complying with UK regulations is critical. One key requirement under the UK Medical Devices Regulations 2002, as amended, is the appointment of a UK Responsible Person (UKRP). This role acts as the manufacturer’s representative in Great Britain, ensuring smooth regulatory communication and compliance with UK authorities, primarily the MH

A New Milestone in European Health Technology Assessment (HTA) On 17 October 2025, the European Commission adopted Implementing Regulation (EU) 2025/2086, establishing detailed procedural rules for conducting joint clinical assessments (JCAs) of medical devices and in vitro diagnostic medical devices (IVDs) at Union level. This long-awaited implementing act builds on the framework of Regulation (EU) 2021/2282 on Health Technology Assessment (HTA) and aligns it with the Medic

Market Entry doesn’t have to be slow or costly. Smart regulatory planning helps startups and manufacturers accelerate access to the EU, UK, US, and beyond transforming compliance from a burden into a strategic advantage. The Global Regulatory Maze - Market entry Expanding into international markets is a defining milestone for every manufacturer—but it can also be one of the most daunting. Divergent frameworks such as EU MDR/IVDR, UKCA, FDA, TGA, and Health Canada regulations

Clinical Decision Support Software in Australia: When Is It a Medical Device? Introduction As digital health technologies evolve, the boundaries between health apps and medical devices have become increasingly complex. To provide clarity, the Therapeutic Goods Administration (TGA) released updated guidance in October 2025 titled “Understanding Clinical Decision Support Software (CDSS)” , outlining how clinical decision support systems are regulated under the Therapeutic Goods

The EU MDR Rule 21 reshapes how substance-based and bioengineered medical devices are classified and approved. Learn how innovators in biomaterials, nanotech, and regenerative medicine can navigate compliance to bring disruptive therapies to market. The Changing Landscape of Medical Device Regulation The introduction of Rule 21 under the EU Medical Device Regulation (MDR 2017/745) has redefined how Europe regulates a new generation of medical devices, particularly those compo

MDCG 2025-7 outlines deadlines for implementing Master UDI-DIs for contact lenses, spectacle frames, and reading spectacles. Ensure MDR compliance with AF Pharma as your EU Authorized Representative.

The UK will align Class D IVD regulations with EU Common Specifications, replacing CTDA and easing market access. AF Pharma offers expert UKRP services to support manufacturers entering the GB market. Learn more at www.afpharmaservice.com.

Explore the latest FDA Q-Sub guidance (2025) updates and learn how AF Pharma can support your FDA submissions as your U.S. Agent for medical devices.

Learn how to create an MDR-compliant PMS Plan, what it must include, and how it supports post-market safety, clinical evaluation, and risk management.