Commonwealth Numbered Regulations
[Index]
[Table]
[Search]
[Search this Regulation]
[Notes]
[Noteup]
[Previous]
[Next]
[Download]
[Help]
THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 2002 No. 236 - REG 4.1
When conformity assessment certificates are required (Act s 41EA)
- (1)
- For paragraph 41EA (a) of the Act and subject to
subregulation (3), the kind of manufacturer in respect of whom a
conformity assessment certificate must be issued before a valid application
can be made for kinds of medical devices manufactured by that manufacturer to
be included in the Register, is a manufacturer who manufactures medical
devices in Australia.
- (2)
- For paragraph 41EA (b) of the Act and
subject to subregulation (3), the kinds of medical devices in respect of
which a conformity assessment certificate must be issued before a valid
application can be made for those kinds of medical devices to be included in
the Register, are medical devices manufactured outside Australia that are of
the following kinds:
- (a)
- medical devices that contain tissues of animal
origin that have been rendered non-viable (other than those that are intended
to come into contact with intact skin only);
- (b)
- medical devices that contain tissues, cells or substances of microbial or
recombinant origin and are intended for use in or on the human body;
- (c)
- medical devices incorporating stable derivatives of human blood or human
plasma that are liable to act on the human body in a way that is ancillary to
the device;
- (d)
- medical devices that incorporate, or are intended to incorporate, as an
integral part, a substance that, if used separately, might be considered to be
a medicine that is intended to act on a patient in a way that is ancillary to
the device.
- (3)
- This regulation does not apply to:
- (a)
- any of the following:
- (i)
- a Class I medical device that is not intended to be supplied in a sterile
state or that does not have a measuring function;
- (ii)
- an exempt device;
- (iii)
- a medical device that is the subject of an approval under section 41HB
of the Act;
- (iv)
- a medical device that is the subject of an authority under section 41HC
of the Act;
- (v)
- a system or procedure pack to which subregulation 3.10 (3) applies;
or
- (b)
- a manufacturer of a medical device of a kind mentioned in paragraph (a).
AustLII: Copyright Policy
| Disclaimers
| Privacy Policy
| Feedback