FDA published the draft guidance on chemical analysis for biocompatibility assessment of medical devices on September 20, 2024.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.
The deadline for transitioning to a higher class for software-based medical devices is November 1, 2024. Sponsors who have not notified the TGA of up classification before May 25, 2022, will need an ARTG entry based on the new classification by November 1, 2024, to continue selling in Australia.
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 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.
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.
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 “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 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[…]
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[…]
Medical Device Single Audit Program (MDSAP), TGA, MDD, IVDD, MDR, IVDR and more……………………………… Achieve access to multiple markets with a single audit The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organizations (Certification Bodies) performing regulatory audits of Medical Device manufacturers’ quality management systems. Termed the Medical Device Single Audit Program (MDSAP), the requirements will be applicable to regulatory authorities, as well as third-party organizations that conduct such audits. What is MDSAP? The objective of the MDSAP is to develop, manage, and oversee a single audit program that will allow a single regulatory audit of a Medical Device manufacturer,[…]
