TFDA – C | M

Cosmetics GMP for Export Purposes (ISO 22716) – Responsible Person

January 12, 2026 adminTGA Sponsor

C | M | S can now act as your European responsible Person. If you are a cosmetics exporter, you may have had been notified by mandated bodies that you require to comply with EC Regulation 1223/2009. What are the requirements for this regulation? All cosmetic products exported to Europe/Asia/NZ will have to be produced according to Good Manufacturing Practices. Cosmetics Good Manufacturing Practices (GMP) is one of the pillars of the New European Regulation for Cosmetics. This regulation sets the requirements to ensure consumers’ safety. Amongst these new legal requirements, all cosmetic products circulating onto the European Market will have to be produced according to Good Manufacturing Practices; a Product Information[…]

MDR 2017/745 and IVDR 2017/746 EU Authorised Representative & EU Importer Services

January 12, 2026 adminTGA Sponsor

Compliance Management Solutions Europe Medical device manufacturers seeking access to the European Union market must comply with the regulatory obligations of MDR (EU) 2017/745, including the appointment of a compliant EU Authorised Representative and, where applicable, an EU Importer. Compliance Management Solutions Europe provides integrated EU Rep and EU Importer services designed to support lawful market access, regulatory continuity, and post-market compliance. As an EU Authorised Representative, Compliance Management Solutions Europe fulfils the responsibilities outlined in Article 11 of the MDR, acting as the manufacturer’s official regulatory presence within the EU. We support manufacturers by verifying the availability and completeness of technical documentation and Declarations of Conformity, maintaining regulatory records,[…]

This New Year, invest in your professional growth and strengthen your regulatory knowledge to stay ahead in the dynamic world of medical devices.

January 12, 2026 adminTGA Sponsor

CMS SciDoc invites Expressions of Interest for our Medical Device Training Programmes – 2026, designed to empower professionals with practical expertise and up-to-date insights into global regulatory requirements.Our programs are crafted and delivered by experienced medical device consultants, blending regulatory theory with real-world, hands-on application to help you achieve compliance confidence. Who should attend?💠 Regulatory Affairs & Quality professionals💠 Medical device manufacturers & sponsors💠 Start-ups entering the medical device market💠 R&D, Clinical, QA/RA, and Compliance teams Proposed training topics:💠 ISO 13485 – Quality Management Systems for Medical Devices💠 ISO 14971 – Risk Management for Medical Devices💠 Process Validation for Medical Devices💠 Medical Device Software💠 Auditor Training💠 Designing a Regulatory Compliant Technical File💠 Clinical Evaluation Report: Tips & Tricks💠 MDSAP[…]

FDA draft guidance for biocompatibility assessment

September 25, 2024 gloizouUncategorized

FDA published the draft guidance on chemical analysis for biocompatibility assessment of medical devices on September 20, 2024. This guidance provides recommendations for the collection and reporting of chemical characterization data that should be used to support medical device market clearance.

TGA proposed changes to the Regulation of Assistive Technologies

July 30, 2024 gloizouUncategorized

The new TGA document, Consultation: Proposed Changes to the Regulation of Assistive Technologies, seeks feedback on the current provisions in the Therapeutic Goods Determination 2018. These provisions classify “household and personal aids, or furniture and utensils for people with disabilities” as excluded goods, meaning they are regulated as consumer goods instead of therapeutic goods.

The EU Commission published AI Regulation EU – 2024/1689

July 23, 2024 gloizouUncategorized

The European Commission published AI Regulation EU – 2024/1689 to establish a uniform legal framework for the development, market placement, deployment, and use of artificial intelligence systems (AI systems) within the Union. Contact us to help you determine how this regulation works for your SaMD.

Guidance on classification rules for IVDs.

July 10, 2024 gloizouUncategorized

MDCG published the revised document ‘Guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746.’ This document addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules set out under Annex VIII.

TGA Regulatory changes to software-based medical devices

July 9, 2024 gloizouTGA Sponsor

Just a reminder to all Medical device software manufacturers and in light of the TGA’s recently published regulatory changes to software-based medical devices, up-classification to most medical device software is almost a definite. Terminology such as screening, risk factor, etc., cannot be considered as class I SaMD. Contact us for a preliminary assessment.

MEDSAFE published the updated document

July 8, 2024 gloizouTGA Sponsor

MEDSAFE published the updated document “Guidelines on the Regulation of Therapeutic Products in New Zealand,” Edition 2, in May 2024, which provides an overview of therapeutic product regulation in New Zealand.

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