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Australian TGA Medical Device Sponsor

12 January 2026 adminTGA Sponsor

As per the Australian TGA Medical Device Regulations, before an individual or company can supply a medical device for sale in Australia, they are required to make an application to include the item in the Australian Register of Therapeutic Goods (ARTG). This registration is crucial for ensuring that the medical devices comply with Australian health standards and are safe for use by the public. The sponsor is defined as the person or company responsible for the importation of therapeutic goods into Australia, playing a vital role in the compliance process. The importance of having a reliable sponsor cannot be overstated. A well-informed sponsor familiar with Australian regulations can expedite the[…]

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

12 January 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FDA draft guidance for biocompatibility assessment

25 September 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FDA published the draft guidance on chemical analysis for biocompatibility assessment of medical devices on September 20, 2024.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

30 July 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

23 July 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.

10 July 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

9 July 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

8 July 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.

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

8 July 2024 gloizouUncategorized

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

TGA ARTG Medical Device Sponsorship

8 July 2024 gloizouUncategorized

As per the Australian TGA Medical Device Regulations, before someone can supply a Medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia. If you are an overseas manufacturer of medical devices and you require Australian ARTG entry, let Compliance Management Solutions act as your sponsor. We aim to provide our customers with the highest level of service with an efficient and cost effective approach. About CMS: CMS is a service provider for the following: Therapeutic Goods: Australian TGA Sponsor for[…]

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