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The Star – SIRIM QAS assures quality of medical devices

THE Covid-19 pandemic has taken its toll on many industries since its outbreak in early 2020. When the Covid-19 pandemic hit, one industry that has managed to weather the storm and thrive is the medical devices sector.

Even prior to Covid-19, Malaysia’s medical device sector was steadily growing with the country being home to 200 manufacturers, of which 30 are multinational corporations (MNCs).

Malaysia’s exports of medical devices surged by nearly 25% in 2020, bringing in RM29.99bil. Much of this figure, about RM17bil, was mainly from exporting surgical and examination gloves. Exports of face masks increased by a whopping 407% from RM12.04mil in 2019 to RM61.1mil in 2020.

Besides manufacturing gloves and face masks, companies in Malaysia also produce medical instruments, apparatus and appliances, catheters, syringes, needles and sutures, and electromedical equipment.

Adherence to high quality standards enables organisations, including those in the medical devices industry, to accrue benefits over time and continually improve products and services for better financial results.

The industry is expected to remain strong even after the impact of the virus has subsided. This is because post-pandemic new normal protocols will include continued regular monitoring of body temperatures and wearing of face masks in crowded, enclosed areas – making these substantial opportunities for players in the medical devices supply chain.

Certification is a must

Before any organisation that manufactures, imports or distributes medical devices in the country can tap into these opportunities, they must first be licensed by the Medical Devices Authority (MDA).

To do so, they must be certified with ISO 13485, an international quality management system standard for medical device manufacturers, or with Good Distribution Practice for Medical Devices (GDPMD) for importers and distributors.

“The ISO 13485 certification affirms that MDA licence holders manufacture medical devices in line with international standards of safety and efficacy,” said SIRIM QAS management system certification head Md Zaini Md Jai.

“With this certification, manufacturers can meet the mandatory requirements in Malaysia and their devices can gain acceptance in the international market,” he said.

The GDPMD certification will also reassure consumers that the medical devices have been stored and transported appropriately throughout the supply chain. This helps ensure that the devices are not tampered with during storage and transit, and also helps to safeguard product safety and performance.

Zaini urges the medical devices industry players to focus on the sustainability challenges and implement effective systems to meet consumer expectations.

More than just being mandated by law, ISO 13485 and GDPMD certifications help boost the confidence of both regulators and consumers. Appointed as a registered Conformity Assessment Body (CAB) by MDA, SIRIM QAS has the expertise to carry out the necessary testing, inspection and certification (TIC) services for both schemes.

With over 25 years of experience in quality control, SIRIM QAS lives up to its reputation for stringent quality with teams of qualified and dedicated auditors to meet testing, inspection and certification needs.

At the same time, SIRIM Berhad recently launched the Medical Device Innovation Centre (MDIC) in Kulim, Kedah, to develop the nation’s medical devices industry and enhance its competitiveness. It was established to build the technological capabilities of industries seeking new innovations in medical devices.

Given that consumers, healthcare providers and even employers are now investing and partnering with innovative vendors to deliver holistic healthcare solutions to consumers, now is the time to seize the opportunity in the medical devices market by getting certified with SIRIM QAS.