To register devices in Malaysia, you must make a dossier submission according to the required items in the Medical Device Act of 2012, and the specific instructions outlined on the Malaysia Medical Device Authority (MDA) website. Starting May 1, the MDA changed the amo...
Malaysia presents a robust and influential market for foreign medical device and drug companies looking to expand their presence to Southeast Asia. The oversight of medical devices in Malaysia falls under theMedical Device Authority(MDA), which operates as part of the Ministry of Health (M...
Malaysia Medical Device Market The medical device market in Malaysia, overseen by the Medical Device Authority (MDA), is estimated to be US$1.4 billion, with a projected growth rate of 16.1%. The pharmaceutical market is also a considerable size, estimated to be US$3.6 billion, with a growt...
Exporters mustcomply with all relevant Quality Assurance requirements outlined by the Ministry of Health (MOH) and MDA prior to exporting any medical device. The requirements vary depending on the type of product being exported, but generally, it includes ensuring that all devices ...
He/she will then submit the documents to the Malaysian Medical Device Authority (MDA) through an online system. Third, an independent Conformity Assessment Body (CAB) reviews the same registration application dossier and then issues a CAB certificate that is submitted to the MDA. The independent ...
Emergo by UL offers authorized regulatory representation for medical device companies looking to sell in the Malaysian market.
and mandatory recall, where the authority in this situation the MDA may in writing order and establishment to recall any medical device at any time due to the patient safety and public health. MDA is open for any consultation if the establishment is unsure regarding the classification of th...
The information on this site is intended for healthcare professionals only. By clicking 'OK', you agree that you fall under this category per the Medical Device Authority Regulations. Click 'Cancel' to be redirected to the Siemens Healthineers Global wesbite. CancelOK ...
The National Pharmaceutical Regulatory Agency is tasked with approving regulations, setting testing and quality control standards, as well as supervising the quality of pharmaceutical products. The Malaysian Drug Control Authority (DCA) mandates that all pharmaceutical products must meet safety, efficacy, ...
Imported medical devices and pharmaceuticals must be registered with theMalaysian Ministry of Health(MOH) by a local authorized representative (for medical devices) or a product registration holder (for drugs). In order to meet this requirement, foreign pharmaceutical or medical device comp...