Commonwealth Consolidated Regulations

THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - REG 4A.31

    For the purposes of subsection   41EWB(2) of the Act, the information is all of the following:

  (a)   the name and address of the body issuing the certificate;

  (b)   the body's ACN (within the meaning of the Corporations Act 2001 );

  (c)   the unique identification number assigned to the body under subsection   41EWA(4A) of the Act;

  (d)   a unique identification number for the certificate;

  (e)   the day on which the certificate is issued;

  (f)   the name and address of the manufacturer of the medical devices;

  (g)   the conformity assessment procedures applied to the medical devices by the manufacturer;

  (h)   if the certificate covers a medical device to which paragraph   1.6(a), (b), (c) or (d) applies--the unique product identifier of the device;

  (i)   if the certificate is varied--the day and details of the variation;

  (j)   if one or more Australian conformity assessment body certificates have previously been issued in respect of the medical devices by the body--the information covered by paragraphs   (a) to (i) in relation to each of those certificates.

Note:   Regulation   5.1 is intentionally not used.