Medicines (Database of Medical Devices) Regulations 2003

Transitional provisions

15 Transitional provisions

(1)

The sponsor of any specified medical device is not required to comply with regulations 6 to 9 in respect of that medical device until the later of the following dates (the applicable date):

(a)

1 January 2005:

(b)

a date after 1 January 2005 specified by the Director-General (by notice in the Gazette) as the compliance date for the purposes of this regulation.

(2)

For the purpose of subclause (1), regulation 6 applies as if for the words “within 30 days of becoming the sponsor of the device” there were substituted the words “within 30 days of the date referred to in regulation 15(1) (the applicable date)”.

(3)

In this regulation, specified medical device means a medical device or kind of medical device, as the case requires, that—

(a)

was manufactured in New Zealand, exported from New Zealand, imported into New Zealand, or sold in New Zealand, before the commencement of these regulations; and

(b)

continues, on or after the applicable date, to be manufactured in New Zealand, exported from New Zealand, imported into New Zealand, or sold in New Zealand.

(4)

The sponsor of a medical device or kind of medical device, as the case requires, is not required to comply with regulations 6 to 9 in respect of that medical device or kind of medical device if—

(a)

the medical device or kind of medical device—

(i)

ceased, before the commencement of these regulations to be manufactured in New Zealand, exported from New Zealand, imported into New Zealand, or sold in New Zealand; or

(ii)

continued to be manufactured in New Zealand, exported from New Zealand, imported into New Zealand, or sold in New Zealand on or after the commencement of these regulations but ceased before the applicable date to be manufactured in New Zealand, exported from New Zealand, imported into New Zealand, or sold in New Zealand; and

(b)

the medical device or kind of medical device is not subsequently manufactured in New Zealand, exported from New Zealand, imported into New Zealand, or sold in New Zealand on or after the applicable date.