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Section 68

Confidential business information

of Medical Device Act 2012

ActIn forceProvision 68 of 80
Section 68
(1)

A person making an application or furnishing any information under this Act may apply to the Authority for confidentiality of any particular

46 Laws of Malaysia ACT 737

information relating to the application or furnishing of information, as the case may be.

(2)

The Authority may grant confidentiality based on the criteria under subsection (3), and where confidentiality is granted, such information shall not be made public.

(3)

The Authority shall consider the claim for confidentiality according to the following criteria:

(a)

that the information is not known generally among, or readily accessible to, persons within the circle that normally deals with the kind of information sought to be made confidential;

(b)

that the information has commercial value;

(c)

that reasonable steps have been taken to keep the information secret;

and

(d)

that the disclosure of the information will harm the competitive position of the person in a manner contrary to honest commercial practice.

(4)

The Authority shall have the power to revoke the confidentiality granted in whole or in part in the interest of public health.