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  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[…]

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[…]

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[…]

by Elizabeth Gasiorowski-Denis on 6 July 2016 With trust, businesses and consumers embark on a lifelong journey towards solutions that will meet their mutual expectations – productivity, performance and quality of life. In theISOfocus magazine (July/August 2016), you’ll learn about how standards help bridge this relationship, instilling confidence on both sides. In her opening comment, Fadilah Baharin, CEO of Department of Standards Malaysia, the ISO member for the country, highlights how ISO standards serve as a barometer by which customers, potential business partners and employees evaluate you and your business. A time for trust “I believe standards instil trust. Standards are no longer about product differentiation but about creating a uniform experience that[…]

by Elisabeth Gasiorowski-Denis on 23 June 2016 http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref2092 With hundreds of thousands of prescription drugs on the market, the pharmaceutical sector faces an increasingly complex and risky challenge. Rapid growth in the number of available medications may be contributing to increased uncertainties. That is where the new ISO IDMP (IDentification of Medicinal Products) series comes in. Up until now, there was no means of identifying medical substances on a global basis. This led to numerous challenges when adverse reactions to medicinal products were reported in one country and had to be interpreted by others. Greater co-ordination among drug regulatory authorities and increased transparency in reporting suspected adverse drug reactions was[…]

by Sandrine Tranchard on 14 June 2016 http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref2091

Get In Contact With CMS For All Your Medical Device Regulatory Consulting. 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. Compliance Management Solutions Melbourne, Australia E: gloizou@compliancems.com.au | 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[…]