By CHARMAINE LIY
Imagine having faulty implants 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 leading to the Medical Device Regulations 2012
The regulations are extensive but a summary will help the reader move forward.
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 use the services of TT MEDICAL.
(Aesthetic Marketing has managed to meet all the requirements in record time and maintained its market share.)
Foreign manufacturers would need to be registered through a Local Authorised Representative.
Our services are available.
One good example is Germanys AAP Joints GmbH which has been successfully introduced
to the Malaysian Market.
These high standards under the MDA would help Malaysia be recognised as a reliable producer
of medical devices in the global market as well as attract foreign direct investment.
Health Director-General, Datuk Dr Noor Hisham Abdullah is quoted in a news report that
the new regulations was aimed at protecting patients and customers from substandard or
unapproved medical devices.
TT MEDICAL also ensures that promotional material meets the new requirements.
Eg. There is now a mandatory requirment that claims are supported by evidence.
Manufacturers, importers and distributors of medical devices are also compelled to report any adverse
incidents or faults involving their products.
The medical industry should move forward quickly and contact a reputable regulatory adviser,
that provides all the services in-house with a guranteed turn-around time.
More Information: https://ttmedical.hospidigital.com