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 registration, let Compliance Management Solutions act as your sponsor. About CMS: Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA/MDD | ISO 9001 (Quality) | 13485 (Medical Devices) | Cosmetics GMP ISO 22716 certification, registration and consultation. Our services include: Ø Australian[…]

The International Organization for Standardization (ISO) is at work on a major revision to the ISO 9001 standard, the internationally-recognized standard that outlines the principles for quality management systems. The revision is currently scheduled for publication in September 2015, and is expected to include a number of important changes for organizations currently holding ISO 9001 certification, as well as those contemplating the development and implementation of a quality management system.  This ISO 9001:2015 version follows the new high-level structure and comprises ten sections: 1.      Scope 2.      Normative references 3.      Terms and definitions 4.      Context of the organisation 5.      Leadership 6.      Planning (including Risk Analysis) 7.      Support 8.      Operation 9.      Performance[…]

As of recent, the TGA was the only Notified Body that can issue Conformity Assessments (CA) for Australian medical device manufacturers (intended to be sold in Australia). Finally, there has been a paradigm shift whereby the TGA will now accept conformity assessments from 3rd party Notified Bodies – what the Australian medical device industry has been pushing for for quite some time now has finally come to fruition. This means that Australian MD manufacturers will no longer require TGA Conformity Assessment to manufacture and sell medical devices here in Australia; European EC Certificates will now be accepted (class dependant). For more information on this regulatory change contact Compliance Management Solutions.[…]

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 new regulation? All cosmetic products exported to Europe will have to be produced according to Good Manufacturing Practices (also includes Asian/US/NZ markets) 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. This can be demonstrated by implementing ISO 22716.  Why implement[…]

  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 new regulation? All cosmetic products exported to Europe will have to be produced according to Good Manufacturing Practices (also includes Asian/US/NZ markets) 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. This can be demonstrated by implementing ISO 22716.  Why[…]

The International Organization for Standardization (ISO) is at work on a major revision to the ISO 9001 standard, the internationally-recognized standard that outlines the principles for quality management systems. The revision is currently scheduled for publication in September 2015, and is expected to include a number of important changes for organizations currently holding ISO 9001 certification, as well as those contemplating the development and implementation of a quality management system.   This ISO 9001:2015 version follows the new high-level structure and comprises ten sections: Scope Normative references Terms and definitions Context of the organisation Leadership Planning (including Risk Analysis) Support Operation Performance evaluation Improvement   How can you prepare?  […]

As of recent, the TGA was the only Notified Body that can issue Conformity Assessments (CA) for Australian medical device manufacturers (intended to be sold in Australia). Finally, there has been a paradigm shift whereby the TGA will now accept conformity assessments from 3rd party Notified Bodies.  It will take a few months however for the Government policy approval to take place and for the changes to come into effect, but what the Australian medical device industry has been pushing for for quite some time now has finally come to fruition. For Conformity Assessment quotations, please contact Compliance Management Solutions.   About CMS: Compliance Management Solutions is an Australian based consultancy assisting organizations[…]

The International Organization for Standardization (ISO) is at work on a major revision to the ISO 9001 standard, the internationally-recognized standard that outlines the principles for quality management systems. The revision is currently scheduled for publication in September 2015, and is expected to include a number of important changes for organizations currently holding ISO 9001 certification, as well as those contemplating the development and implementation of a quality management system. This ISO 9001:2015 version follows the new high-level structure and comprises ten sections: Scope Normative references Terms and definitions Context of the organisation Leadership Planning (including Risk Analysis) Support Operation Performance evaluation Improvement How can you prepare? Organisations that have[…]

Currently, the TGA is the only Notified Body in Australia that can issue Conformity Assessments (CA). There has been significant movement with respect to CA for Australian medical device manufacturers. It is expected that in 2015 the TGA will accept conformity assessments from 3rd party Notified Bodies.   If you require further information regarding this significant change or a CA quotation, please do not hesitate to contact Compliance Management Solutions.   About CMS:  Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA | ISO 9001 (Quality) | 13485 (Medical Devices) | Cosmetics GMP ISO 22716 certification, registration and consultation. Our services include:  •        Australian ARTG registration/sponsorship/consultancy (medical devices/medicinal products) •       […]

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 new regulation? All cosmetic products exported to Europe will have to be produced according to Good Manufacturing Practices (also includes Asian/US/NZ markets) 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. This can be demonstrated by implementing ISO 22716.  Why implement[…]