The Malaysian Medical Devices Authority (MDA) wants to notify everyone that screening and inspection of medical device imports at the country's main entry points is one of the mechanisms to prevent the illegal importation of medical devices into the Malaysian market. Also, MDA wants to remind everyone, including the establishment that imported medical devices must be registered and imported by licensed establishments, as specified in sections 5 (1) and 15 (1) of the Medical Devices Act 2012 (Act 737), or obtain any approval issued by MDA.
Therefore, the establishment or any party involved in medical device importation activities is reminded to provide relevant documents such as:
a. A license Certificate,
b. Registration Certificate,
c. Letter of Approval,
d. Notification Letter,
e. Letter of authorization, or
f. Other relevant documents
Those documents are required to avoid disruptions in the activities of medical device importation and release through the country's entry gates.
MDA would also like to remind anyone who is found guilty of violating sections 5 (1) and 15 (1) of Act 737 that they can be fined up to RM200,000 or imprisoned for up to two years, or both, as provided in sections 5 (2) and 15 (2) of Act 737.
Screening and Inspection at Main Entrance to Restrict The Activity of Importation of Medical Devices Without A License and Valid Registration and Authorization