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- Rofin Australia Pty Ltd. is pleased to announce it has received from the Australian Government's Therapeutic Goods Association (TGA) a QUALITY SYSTEM CERTIFICATE – Certificate Number AU Q00083/01dated 5th May 2007 – 26th October 2011. This certifies that the Rofin has been assessed by the Manufacturers Assessment Branch TGA, and has been found to comply with the requirements of ISO 13485:2003 (excluding clause 7.3 not assessed), for the manufacture of skin surface treatment applicator, light (GMDN 45222).
- Rofin Australia Pty Ltd. is pleased to announce it has received from the Australian Government's Therapeutic Goods Association (TGA) an CERTIFICATE FOR INCLUSION OF A MEDICAL DEVICE – ARTG Product Number and Name 222687 – Skin surface treatment system applicator, light, commencement date 13th March 2007.
- Rofin Australia Pty Ltd. is pleased to announce it has received from the Australian Government's Therapeutic Goods Association (TGA) a CE CERTIFICATE – Production Quality Assurance Procedures. Certificate Number MRA Q00037/01dated 6th March 2007 – 6th March 2012. This certifies that the Rofin Production Quality Assurance System conforms to the relevant provisions of Annex V of the Council Directive 93/42/EEC on Medical Devices.
- Rofin Australia Pty Ltd. is pleased to announce it has received Australian Therapeutic Goods Association (TGA) Conformity Assessment Certification – Production Quality Assurance Procedures. Certificate Number AU Q00083/01 dated 6th March 2007 – 6th March 2012 This certifies that the Rofin quality management system complies with the relevant provisions of Schedule 3-Part 4 of the Therapeutics Goods (Medical Devices) Regulations 2002.
