News – Page 4 – C | M

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

July 8, 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

July 8, 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[…]

Medical Device Single Audit Program (MDSAP), TGA, MDD, IVDD, MDR, IVDR and more………………………………

July 8, 2024 gloizouUncategorized

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,[…]

C | M | S GONE GLOBAL

July 8, 2024 gloizouTGA Sponsor

Need Australian TGA / European EU Rep / UK RP or Asian Medical Device Representation? MEDICAL DEVICES LICENSE HOLDING / TGA SPONSORSHIP / EC REPRESENTATION Our latest service just launched and we’ve gone GLOBAL! Check out our website for more information and quotation. Compliance Management Solutions Melbourne, Australia (Head Office) E: gloizou@compliancems.com.au M: +61 433 124 266 W: https://compliancems.com.au

Software as Medical Device (TGA)

July 8, 2024 gloizouTGA Sponsor

The TGA transition period for software-based medical devices that met the regulatory changes set on 25 February 2021 ends on 1st November 2024. You will have until 1st November 2024 to apply for a conformity assessment with the TGA and to include your device in the ARTG list under the new, higher classification. Contact us to help you with this transition and to assist you with TGA conformity assessment.

Demonstrating cybersecurity compliance for your medical device.

July 5, 2024 gloizouUncategorized

There are published guidance documents including checklists on how medical device manufacturers can demonstrate cybersecurity compliance. Checking your devices against these guidelines can help you prepare your technical files for submission and auditing.

MDCG revised document, MDCG 2022-4 Rev 2

June 18, 2024 gloizouUncategorized

The MDCG has released a revised document, MDCG 2022-4 Rev 2, Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD. This guidance document outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 120(3e) MDR.

A new updated standard, (EN) ISO 17665:2024

June 5, 2024 gloizouUncategorized

There’s a new updated standard, (EN) ISO 17665:2024, sterilization of healthcare products using moist heat. This document provides requirements for the development, validation, and routine control of moist heat sterilization processes for medical devices. Of course it includes Annex ZA, relationship between the standard and the GSPR requirements of the MDR 2017/745. This sterilization method is primarily used in hospitals, including CSSD Departments, for the sterilization and re-sterilization of medical devices consisting of hard polymers and metals such as PEEK, Titanium and stainless steel. It will also be used for the upcoming EU new classification, class Ir, for the re-sterilization of reusable surgical instruments.

Responsibilities of an importer under Union Harmonisation Legislation.

June 4, 2024 gloizouUncategorized

According to the official journal of the European Union (the Blue Guide) C 247, section 3.3, importers have important and clearly defined responsibilities under Union Harmonisation legislation. To a large extent, importers build on the type of responsibilities which a manufacturer based in the EU is subjected to and the importer must ensure that the manufacturer has correctly fulfilled his obligations.

Time is running out to qualify for the EU MDR transition extension.

May 30, 2024 gloizouUncategorized

Time is running out to qualify for the EU MDR transition extension as per the regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746. Manufacturers must apply for MDR certification with an MDR notified body by 26 May 2024 and before their MDD certificate expires. For new TGA ARTG entries, evidence must be submitted as part of the application. Contact us for more information.