THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 2002 No. 236 - REG 5.7 Conditions applying automatically — period for giving information about adverse events etc (Act s 41FN)

Commonwealth Numbered Regulations

Conditions applying automatically — period for giving information about adverse events etc (Act s 41FN)

(1): For paragraph 41FN (3) (d) of the Act, the period in which a person in relation to whom a kind of medical device is included in the Register must give information of a kind mentioned in subsection 41MP (2) of the Act to the Secretary is:

(a): if the information relates to an event or other occurrence that represents a serious threat to public health — 48 hours after the person becomes aware of the event or occurrence; and
(b): if the information relates to an event or other occurrence that led to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person — 10 days after the person becomes aware of the event or occurrence; and
(c): if the information relates to an event or other occurrence a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person — 30 days after the person becomes aware of the event or occurrence.

(2): For paragraph (1) (a), an event or other occurrence, in relation to a kind of medical device, represents a serious threat to public health if:

(a): the event or other occurrence is a hazard arising from a systematic failure of the device that becomes known to the person in relation to whom the device is included in the Register; and
(b): the event or other occurrence may lead to the death of, or a serious injury to, a patient, a user of the device or another person; and
(c): the existence of, probable rate of occurrence of, or degree of severity of harm caused by, the hazard was not previously known or anticipated by the manufacturer of the device; and
(d): the manufacturer will be required to take prompt action to eliminate, or reduce the risk of, the hazard.

(3): For paragraphs (1) (b) and (c), an event or other occurrence leads to a serious deterioration in the state of health of a person if the event or other occurrence causes, or contributes to:

(a): a life-threatening illness or injury suffered by the person; or
(b): a permanent impairment of a bodily function of the person; or
(c): permanent damage to a body structure of the person; or
(d): a condition requiring medical or surgical intervention to prevent such permanent impairment or damage.

AustLII: Copyright Policy | Disclaimers | Privacy Policy | Feedback