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 about comes under the Medical Device Regulations 2012.
This new law helps to 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 industry.

The MDA has set October 31 this year as a deadline for manufacturers to comply with the registration. However it is not known yet if the implementation of the law will take effect on January 1, 2018 as planned or moved to slightly later.These two deadlines as set out below are two key timeline set by the MDA.

> October 31, 2017: Deadline to complete registration applications in the MDA’s Medical Device Centralised Online System (MeDC@ST) online portal. Registrants whose applications are still being processed by their Conformity Assessment Bodies (CAB) will have to finalise their certifications and submit them to the MDA by this deadline.
>January 1, 2018: Deadline for obtaining official registration certificates from the MDA. From this date onwards, companies may no longer use acknowledgment letters to import and sell their devices in Malaysia.(Acknowledgment letters were issued to Malaysian market applicants that submitted their applications before June 30, 2016; companies may currently use these letters to sell their devices in Malaysia while the MDA reviews their registration submissions.

Instead of making our readers go through reams and reams of technical reports and documents, we have summarised some basic but valuable information on the new law and it’s bites on medical device manufacturers in this article.
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(

Foreign manufacturers on the other hand would need to be registered through a Local Authorised Representative like us. Please click (

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..
“A Magistrate may issue a warrant to permit an authorised officer to search premises for reasonable cause. An authorised officer may also investigate without a warrant for reasonable cause.An authorised officer may also take samples for analysis. As a general penalty, anyone who violates the Medical Devices Act 2012 may be liable for a fine and/or a term or imprisonment.”

Health director-general Datuk Dr Noor Hisham Abdullah is quoted in a news report that the new regulations was aimed at protecting patients and other customers from substandard or unapproved medical devices.
Manufacturers will have to pay special attention to their advertisements as well as the new regulations would also shield buyers from misleading or fraudulent advertisements. There is now a mandatory need for all claims to be supported by evidence.

Dr Noor Hisham also reportedly said the protection provided by the regulations included misuse of devices by unqualified or untrained personnel.

“Manufacturers, importers and distributors of medical devices are also compelled to report any adverse incidents or faults involving their products.

“This is mandatory and applies even if an incident occurs outside Malaysia,” he was quoted as saying in the news report.

The cases could be faults in devices, deterioration in effectiveness or inadequate labelling or instructions.
Dr Noor Hisham said an incident must be reported to the MDA within 30 days of occurrence.
“But if the incident results in death or serious deterioration in the health of a patient, it must be reported within 10 days.”

The Medical Device Act is therefore expected to shake up companies in the industry.
So be prepared or get help from those who can prepare you. Wait no more. Go to (

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