July 13, 2018
According to Section 5(1) Act 737, all medical devices to be imported, exported or placed in the market in Malaysia must be registered under this Act. However, considering that export only medical devices do not pose any risks to the public because they do not enter the Malaysian market, MDA has decided to not strictly impose the registration requirements in Section 5 Act 737 on them.
Thus, MDA has issued a Circular Letter No. 4 Year 2018 on 22 May 2018, effective from the issuance date, which allows for the implementation and enforcement for exemption from registration requirement for export only medical device with the following requirements:
a) Compliance with notification requirements with certain charges as may be specified by MDA;
b) The medical device is not allowed to be placed in Malaysia market; and
c) Compliance with establishment license requirement under Section 15 of Act 737.
This exemption has been implemented administratively before order is published in the Gazette, which is soon to take place.
Exemption from Registration Requirement for Export only Medical Device