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Frequently Asked Questions About Medical Services
Q: Is the ISO 13488:1996 standard still valid? A: ISO 13485:2003 includes provisions for both manufacturers and service providers with/without design activities. After the transition periods end in 2006, the ISO 13488:1996 standard will become obsolete. Q: Will Health Canada accept an Australian TGA audit inspection /GMP certificate as evidence that an Australian manufacturer meets the ISO 13485 requirements as a means of retaining or obtaining a license to sell its devices in Canada after the 2003 deadlines? Or are overseas companies expected to undertake and audit by an SCC qualified CMDCAS registrar? A: Often, we are asked if ISO 13485 certificates issued by another accredited body will satisfy the Canadian Medical Device Regulations. For the purposes of obtaining a license for the distribution of medical products in Canada, Health Canada will not accept:
The Quality System requirements of the Canadian Medical Device Regulations (CMDR) apply to ALL Canadian AND foreign manufacturers of Class II, III and IV medical devices. This includes own brand labelers, since this group meets the Canadian definition of a manufacturer and takes responsibility for all aspects of the device. While importers and distributors are not required to meet the quality system requirements, those foreign manufacturers meeting the definition of a Canadian manufacturer and either importing to Canada or distributing in Canada itself or via another entity, are manufacturers...not importers or distributors. Q: What are the differences between ISO 13485:2003 and CSA-ISO 13485:2003? A: There is no difference between the ISO 13485:2003 and the CSA-ISO 13485:2003 standards. These standards are identical, with the difference being that CSA adopted ISO 13485:2003 as a Canadian standard. Q: What are some of the issues companies are facing when preparing for a CMDCAS audit? A: During our CMDCAS audits, TÜV SÜD America has found that many companies have prepared themselves extensively using the ISO 13485 standard, while not considering the requirements of the Canadian Medical Devices Regulations. Meeting the ISO 13485 standard is just a portion of the requirements. Organizations looking to become certified must also consider the requirements of the Canadian Medical Devices Regulations in preparation for their CMDCAS audit. Ensure that the requirements of the Canadian Medical Devices Regulations are incorporated into your company's Quality System. When auditing, TÜV SÜD America is not only determining CMDCAS compliance based upon the ISO 13485 standard alone, but if the requirements of the Canadian Medical Devices Regulations are incorporated into the appropriate elements of the companies' quality systems. Q: Is TÜV SÜD currently qualified to issue compliance certificates to ISO 13485 that will satisfy the Canadian CMDCAS requirements? A: Yes. TÜV SÜD America Inc., Management Service division is one of 15 accredited registrars who can assess your quality system to ISO 13485 and issue a CMDCAS Quality System certificate. Q: What costs are and timeframes are associated for registration? A: TÜV SÜD America has a sliding cost structure based primarily on the size (number of employees and facilities) that must be audited. The timeframe associated with registration would depend on the types of products, location, and the availability of auditors who are properly authorized for your products. Contact us for a quote and/or scheduling details. Q: How do I know if my company requires a Canadian establishment license? A: The establishment license regulations apply to everyone who:
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