(1)

For paragraph 41FH (1) (a) of the Act and subject to subregulation (2), an application for any of the following kinds of medical devices to be included in the Register is prescribed:

(a)

a medical device (other than a condom) that is a barrier indicated for contraception or prevention of the transmission of disease in the course of penile penetration during sexual intercourse;

(b)

a medical device that is an implantable contraceptive device;

(c)

a medical device that is an implantable breast prosthesis containing material of fluid consistency (other than water only or a saline solution only);

(d)

a medical device of a kind described in subclause 5.3 (2) of Schedule 2;

Note
Subclause 5.3 (2) of Schedule 2 applies to a medical device that is specifically intended by the manufacturer to be used for disinfecting another medical device.

(e)

a Class AIMD medical device;

(f)

a medical device that is a prosthetic heart valve;

(g)

a medical device that is an implantable intra-ocular lens;

(h)

a medical device that is an intra-ocular visco-elastic fluid;

(i)

a Class III medical device that has not been assessed under the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement.

(2)

Subregulation (1) does not apply to an application for a kind of medical device to be included in the Register if a conformity assessment certificate has been issued, and has not been suspended or revoked, in respect of the kind of medical device.

(3) For this regulation:

(a)

a medical device is assessed under the EC Mutual Recognition Agreement if the device is assessed by a conformity assessment body designated by the European Community; and

(b)

a medical device is assessed under the EFTA Mutual Recognition Agreement if the device is assessed by a conformity assessment body designated by the European Free Trade Association.