Section 10
Section 10
A conformity assessment body shall be a body registered under this
Act to carry out conformity assessment of a medical device to be registered under this Act.
(2)
The person who is in charge of and has overall control over a conformity assessment body shall be a Malaysian citizen.
(3)
A conformity assessment body shall be independent and shall not have, acquire or hold any interest, directly or indirectly, in relation to—
(a)
any medical device under its assessment;
(b)
any shares in the establishment whose medical device is assessed by it; or
(c)
any related company of the establishment whose medical device is assessed by it.
(4)
A conformity assessment body shall not disclose any information received during the conformity assessment procedures carried out on any medical device.
(5)
A conformity assessment body shall be audited by the Authority from time to time as may be deemed necessary by the Authority.