27 Dec It’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 by the Conformity Assessment Body.
The recognition came in a recent circular prepared by the Medical Device Authority (MDA) to facilitate the stakeholder and industry in the implementation of Medical Device Act (Act 737) Medical Device Act (Act 737) and the regulations under it.
The Circular Letter, among others, mentioned that Regulation 4(1) of Medical Device Regulation 2012 requires that all medical devices should be subjected to conformity assessment to demonstrate its conformity in line with the requirement of the latest medical device law in Malaysia.
Under Regulation 4(2), manufacturers of medical devices are required to collect all evidence of conformity, appoint a conformity assessment body to conduct assessment on the conformity.
One of the conformity assessment is on technical documentation. Prior to this circular, there was no local body in terms of assessment on this aspect. The move to recognise IMR is aimed at reducing the costs and time for manufacturers as the time and costs of conducting overseas assessment is rather high.
The Medical Device Regulations 2012 was established to help regulate manufacturers of medical devices to be up to standard – albeit set by the Medical Device Authority (MDA), a body under the Health Ministry tasked with supervising the country’s Medical devices are defined as any medical technology, supplies and equipment which encompass instrument used for diagnosis, prevention, monitoring and treatment of illness or handicap but exclude drugs.They would be categorised depending on the risk level and intended use.
Under the regulations, those producing or importing these items must register the products with the MDA.
Malaysian manufacturers of medical devices can either register on their own or do it through a regulatory consultant like us. Just click(https://ttmedical.com.my/malaysia-medical-device-license-application/)
Foreign manufacturers on the other hand would need to be registered through a Local Authorised Representative like us. Please click (https://ttmedical.com.my/malaysia-medical-device-license-application/)
According to experts, the regulated standards under the Medical Device Regulations would help Malaysia be recognised as a reliable producer of medical devices in the global market as well as attract foreign direct investment.
According to a World Health Organisation report, an authorised officer may investigate any potential violations of the Medical Devices Act 2012 and if found guilty, the manufacturer may be liable to a jail term or fine.