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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Tag: Compliance Management Solution
Cosmetics GMP for Export Purposes (ISO 22716) – Responsible Person
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[…]
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TGA ARTG Medical Device Sponsorship
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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Medical Device Single Audit Program (MDSAP), TGA, MDD, IVDD, MDR, IVDR and more………………………………
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,[…]
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C | M | S GONE GLOBAL
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: [email protected] M: +61 433 124 266 W: https://compliancems.com.au
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Software as Medical Device (TGA)
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.
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EU MDR 2017/745
GOODBYE GMDN………………….HELLO EMDN The EMDN will be the nomenclature used when registering medical devices In the Eudamed database. Although mapped to the current GMDN Nomenclature, it is stand alone and will be used in future as a searching tool by EU Operators. SPEAK TO US TODAY George Loizou | Director | MDD/MDSAP/MDR Notified Body/AO Lead Auditor | MDD/MDR Notified Body Technical File Reviewer | Contact us on: C | M | S – Compliance Management Solutions – Leaders In Compliance (Australia, Europe, Vietnam, Singapore, Malaysia, NZ) M: +61 4 33 124266 W: compliancems.com.au E: [email protected] North Melbourne, Victoria
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C | M | S GONE GLOBAL
Need Australian TGA / European EU Rep 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: [email protected] M: +61 433 124 266 W: https://compliancems.com.au
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