September 17, 2018
In July 2018, Medical Device Authority (MDA) had issued Circular Letter No.4 Year 2018. This was pertaining medical devices manufactured or imported into Malaysia for eventual exportation purposes only. According to Section 5(1) of Medical Devices Act 2012 (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 of 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.
However, recently, with the issuance of Circular Letter No.4 Year 2018 (Revision 1), MDA has decided that these export only medical devices will have to comply with the following requirements:
a) Exemption from medical device registration requirement under Section 5 of Act 737
b) Compliance with notification requirement with certain charges as may be specified by the Authority, and
c) Not allowed to place export-only medical device in Malaysian market
This circular letter is implemented immediately.