New UK CE Certificate Rules for ARTG Inclusion Applications

The TGA has released the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination 2025, introducing new provisions regarding evidence requirements for ARTG inclusion applications. These changes will take effect on December 1, 2025. 

This ARTG inclusion applications update supports international harmonization efforts of the TGA and is intended to reduce administrative duplication and streamline processes for manufacturers operating across multiple jurisdictions.  

Key Changes Regarding ARTG Inclusion Applications

• Recognition of UK Regulatory Frameworks: The amendment incorporates references to the UK Medical Devices Regulations 2002 (SI 2002/618), recognizing certificates and documentation issued by UK Approved Bodies under the applied EU Directives 90/385, 93/42, and 98/79. 
• Expanded Definitions: New definitions have been added for applied Directive 90/385, 93/42, and 98/79, along with a definition of UK approved body. 
• Broadened Recognition of Auditing Authorities: The determination now covers both recognized and authorized auditing organizations under the Medical Device Single Audit Program (MDSAP).
• Alignment with U.S. FDA Processes: The new provision allows MDSAP certificates for medical devices exempt from the FDA’s section 510(k) requirements, provided a supporting statement outlines the device name, description, and regulatory classification. 

Implications for Manufacturers 

From December 2025, manufacturers seeking to include medical devices on the ARTG may now submit certificates from UK Approved Bodies, where applicable, and MDSAP certificates from “authorized” auditing organizations, alongside previously recognized bodies. 

How MedEnvoy Can Support 

At MedEnvoy, we help manufacturers navigate complex and evolving regulatory requirements across international markets including ARTG inclusion applications. With the December 2025 amendments introducing new evidence pathways, our team of compliance and regulatory specialists can assist with: 

• ARTG application management – From initial submissions through post-market compliance, we streamline the entire regulatory lifecycle for your medical devices. 
• International regulatory strategy – We develop tailored approaches that leverage recognition agreements and harmonized frameworks to optimize market access across multiple jurisdictions. 
• Documentation assessment – Our experts can evaluate your existing conformity certificates and quality assurance documentation to identify the most efficient pathway under the new provisions.
• Compliance monitoring – We keep you informed of regulatory changes and ensure your ongoing obligations are met across all markets.

Whether you’re looking to leverage the new UK certificate recognition pathways or gain a better understanding of TGA regulatory requirements, MedEnvoy can help you navigate the process. Our expertise ensures that your registration meets the applicable standards, enabling safe ongoing compliance. We encourage you to contact our team for tailored support. Contact us so we can assist you.