P
pschnoor9
I am looking to declare conformity for a class IIa device in Australia. I have found the ComLaw regs for Therapeutic Goods (Medical Devices), and although it speaks to declaring conformity, it does not give enough specific information.
If we can demonstrate that our product conforms per the ComLaw standard, is that enough to issue a DoC? If so, is there a standard template?
If not, what is the process to follow to declare conformity? Does Australia accept EC certification? We are certified to ISO 13845, IEC 60601.1-1, ISO 9001:2003, and the MDD (93/42/EEC).
Any advice is appreciated.
patricia
USA
If we can demonstrate that our product conforms per the ComLaw standard, is that enough to issue a DoC? If so, is there a standard template?
If not, what is the process to follow to declare conformity? Does Australia accept EC certification? We are certified to ISO 13845, IEC 60601.1-1, ISO 9001:2003, and the MDD (93/42/EEC).
Any advice is appreciated.
patricia
USA