Australia Therapeutic Goods (Medical Devices) Regulations 2002 r3.4-3.10: Apply the conformity assessment procedures the Regulations set for the device's class (or a higher class's procedures if preferred), including the extra steps for sterile, measuring, in-house IVD and special purpose devices

What does r3.4-3.10 require?

Section 41DA of the Act and regulation 3.4 require the manufacturer to apply to each device the conformity assessment procedures of Schedule 3 that fit its class, and for Class IIb, IIa, I and IVD Classes 1 to 3 it may elect the procedures of a higher class. Class III: full quality assurance, or type examination plus verification or production quality assurance (sterile Class III: full QA or type examination with production QA). Class 4 IVD: full QA, or type examination with production QA. Class 4 in-house IVD: full QA or Schedule 3 Part 6B. Class IIb: full QA without design examination, or type examination plus verification, production QA or product QA. Class IIa: full QA without design examination, or a declaration of conformity combined with verification, production QA or product QA (sterile: production QA). Class 2 and 3 IVD: full QA without design examination, or the paired routes. Class I and Class 1 IVD: the declaration of conformity procedures, adding production QA if sterile and verification, production QA or product QA if there is a measuring function. Class 1 to 3 in-house IVDs use Part 6A. Special purpose devices (exempt devices, clinical trial approvals, authorised prescriber supplies and qualifying system or procedure packs) use Part 7, with sterile packs also needing full or production QA. Where the procedures require information to go to the Secretary, it must be given to the Secretary even if a delegated body also receives it.