PART 4Medical devices

CHAPTER 3Enforcement

Enforcement notices

I124Information notices

1

This section applies where the enforcement authority considers that a person has information which the enforcement authority needs for the purpose of deciding whether to—

a

serve or revoke a compliance notice,

b

serve or revoke a suspension notice, or

c

serve, vary or revoke a safety notice.

2

The enforcement authority may serve on the person a notice (an “information notice”) requiring the person—

a

to disclose to the enforcement authority information specified in the notice, within a period specified in the notice, or

b

to produce records specified in the notice at a time and place specified in the notice, and to permit a person appointed by the enforcement authority to take copies of the records at that time and place.

3

A period specified in reliance on subsection (2)(a) must be a period of at least 28 days beginning with the day on which the notice is served.

4

A time specified in reliance on subsection (2)(b) must be at least 28 days after the notice is served.

5

The enforcement authority may vary or revoke an information notice.