SIRIM enhances capabilities of Malaysia’s medical device manufacturers through proper certification and compliance
Medical device manufacturers must demonstrate that their products have been appropriately certified and meet the required international standards.
It is significant because 90 per cent of all such medical devices manufactured in Malaysia are destined for the export market.
SIRIM Berhad’s subsidiary SIRIM QAS International can provide this certification service (SIRIM QAS). SIRIM QAS, the country’s leading testing, inspection, and certification (TIC) centre, can audit and certify that a manufacturer complies with such standards. Furthermore, the Medical Device Authority (MDA) — an agency under the Ministry of Health (MoH) — has designated the organisation as a Conformity Assessment Body (CAB).
Being a CAB allows SIRIM QAS to audit and certify whether a manufacturer complies with ISO 13485 Medical Devices and Good Distribution Practice for Medical Devices (GDPMD), both management systems certifications.
ISO 13485, for example, applies to any entity that designs, develops, or manufactures medical devices. It should be noted that under the Medical Device Act of 2012, all medical device manufacturers must be ISO 13485 certified. At the same time, companies involved in the storage, distribution, installation, servicing, or disposal of medical devices are encouraged to become certified.
GDPMD, like ISO 13485, is a critical certification for those involved in the medical device supply chain. It demonstrates that the holder can ensure medical devices’ quality, safety, and performance under its care. This includes medical device importers and distributors, as well as foreign manufacturer representatives in Malaysia.
Performance and safety standards
SIRIM QAS also conducts tests to ensure that medical devices meet safety and performance standards. This is required for the product to be sold on both domestic and international markets. These include, but are not limited to, electrocardiogram (ECG) machines, incubators, and high-frequency surgical devices.
Because such devices are critical in diagnosing and treating various medical conditions, it is even more imperative to be free of flaws and malfunctions. Power surges and voltage spikes, for example, could not only damage the equipment but also cause serious injury to operators and patients.
Under the International Electro-technical Commission (IEC), medical electrical equipment can be certified compliant with the IEC 60601 series. SIRIM QAS performs testing and certification for IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-x.
This demonstrates the breadth of its expertise and reassures medical device manufacturers looking to set up shop in Malaysia that their products will be appropriately certified.
Global quality assurance
The Covid-19 pandemic has also highlighted the importance of ensuring the quality of all medical devices, particularly medical face masks and gloves. The latter is especially important in Malaysia, as the country is the world’s largest supplier of such products.
As a result, SIRIM QAS has broadened its testing and certification services to include medical face masks and gloves manufactured, imported into, or sold in Malaysia. With the current global health situation, this service helps protect public health. It ensures that Malaysia has a positive reputation as a source of such equipment.
Currently, SIRIM QAS is providing a 20 per cent rebate to manufacturers of face masks under the package service for testing and certification till Dec 31, subject to terms and conditions.
Leading the way in 5G medical devices
In addition, as the Internet of Things (IoT) becomes more prevalent, an increasing number of medical devices include wireless connectivity features.
People with Type 1 diabetes, for example, may have insulin pumps that record the time and level of dosage. It then sends the reports via Bluetooth to their mobile devices, allowing them to track their medication.
In Malaysia, the Malaysian Communi-cations and Multimedia Commission (MCMC) regulates connected devices with communication capabilities. SIRIM QAS is the designated certifying agency for such devices. It performs testing and certification to determine if they meet Malaysia’s spectrum plan, regulatory requirements, and technical requirements covering radio frequency (RF), interoperability, safety, electromagnetic compatibility (EMC), and specific absorption rate (SAR), if applicable.
One of Malaysia’s 5G verticals’ goals is to grow the digital healthcare industry. As a catalyst to accelerate the adoption of 5G related technologies in the local healthcare industry, MCMC’s 5G Demonstration Project has provided a platform for collaborations between the healthcare industry and telcos.
An example is a collaboration between the Hospital Sultanah Maliha, Digi and CREST. It showcases 5G-connected ambulances that enable real-time medical data transfer between paramedics attending to emergency cases and the hospital.
Another strategy for boosting the industry is to increase the capacity of the medical device manufacturing sector to produce connected medical devices. As a result, SIRIM QAS plays a vital role in elevating Malaysia to that level. — The Health