Regulatory Updates
Stay informed on the latest medical device regulations, MDA requirements and compliance updates in Malaysia.
Medical Device Regulations
Faulty tubes or pacemaker or even a leaking catheter are the last things patients need because they may pose risks to their life. This is one good reason for the Malaysian government to impose the regulation to make it compulsory for manufacturers of medical devices to register their products. The law that we are talking […]
New Law Helps to Regulate Manufacturers of Medical Devices
Imagine having faulty implants or pacemaker that start to give way not long after they are placed in your body. They are meant to save your life but do not meet the expectation. These are some of the concerns that had given birth to the Medical Device Regulations 2012. This new law helps to regulate […]
Why You Must Register?
Faulty tubes or pacemaker or even a leaking catheter are the last things patients need because they may pose risks to their life. This is one good reason for the Malaysian government to impose the regulation to make it compulsory for manufacturers of medical devices to register their products. The law that we are talking […]
It’s Cheaper Now with IMR
The Medical Device Authority of Malaysia has decided to recognise the Institute for Medical Research (IMR) as one of the institutions that is capable of providing the report or data of clinical evidence or performance evaluation for the purpose of conformity assessment by the Conformity Assessment Body. The recognition came in a recent circular prepared […]
