THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 2002 No. 236 - REG 3.6 Class III medical devices and Class AIMD medical devices (other than medical devices used for a special purpose)

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THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 2002 No. 236 - REG 3.6

Class III medical devices and Class AIMD medical devices (other than medical devices used for a special purpose)

(1): Subject to subregulation (2), the conformity assessment procedures that must be applied to a Class III medical device, or a Class AIMD medical device, (other than a medical device used for a special purpose) are, as the manufacturer prefers:

(a): the full quality assurance procedures; or
(b): the type examination procedures and:

(i): the verification procedures; or
(ii): the production quality assurance procedures.

(2) If the device is intended by the manufacturer to be supplied in a sterile state, the conformity assessment procedures that must be applied to the device are, as the manufacturer prefers:

(a): the full quality assurance procedures; or
(b): the type examination procedures and the production quality assurance procedures.

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