Guidelines for implementation of medical device regulatory system.
Guidelines for Drug Registration, April 2011 Revision
Reference
Medical Device Regulations
By CHARMAINE LIY 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...
27 December, 2017It’s cheaper now with IMR
By CHARMAINE LIY 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...
27 December, 2017Why you must register?
By CHARMAINE LIY 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...
27 December, 2017New Law Helps to Regulate Manufacturers of Medical Devices
By CHARMAINE LIY 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...
10 July, 2017
T T Medical Management Sdn Bhd is an established Authorised Representative (“AR”) company. We are licensed by the Medical Device Authority (“MDA”) which regulates medical devices under the “Medical Device Act 2012” and “Medical Device Regulations 2012”. Under the regulation, all foreign manufacturers must appoint an AR to submit the registration application of their medical devices. For more details of the MDA , please visit Medical Device Authority (MDA) Malaysia.
