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Medical Device Single Audit Program (MDSAP) – TGA 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 the 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, conducted by an MDSAP[…]

It’s that time of year again for companies to review their Medical Device Sponsorship costs. Before you roll over for another year with your existing Sponsor, get a quote from us! We have saved our clients thousands, let us see how much we can save you too! Speak to one of our leading specialists today for your hassle free transfer or see our website for a free quotation. Compliance Management Solutions Melbourne, Australia E: [email protected] M: +61 433 124 266 W: https://compliancems.com.au

The Council of the European Union will be publishing the new 2017 Medical Device Regulations (MDR).   A summary of the major changes are illustrated below. For further information please contact Compliance Management Solutions on: E: [email protected] M: +61 4 3312 4266 W: compliancems.com.au    

MEDICAL DEVICES LICENSE HOLDING / SPONSORSHIP Our latest service just launched and we’ve gone GLOBAL! Check out our website for more information and quotation.   Compliance Management Solutions Melbourne, Australia E: [email protected] M: +61 433 124 266 W: https://compliancems.com.au

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: Cosmetics: Cosmetics GMP ISO 22716 implementation[…]

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 File (PIF) is also required to demonstrate the cosmetic safety assessment.  This[…]

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 the 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, conducted by an MDSAP recognized auditing organization, to satisfy the needs of[…]

MEDICAL DEVICES LICENSE HOLDING Our latest service just launched and we’ve gone GLOBAL! Check out our website for more information.   Compliance Management Solutions Melbourne, Australia E: [email protected] M: +61 433 124 266 W: https://compliancems.com.au

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: Cosmetics: Cosmetics GMP ISO 22716 implementation[…]