Implementation of medical device regulations to augur well for domestic market, says Fitch

PETALING JAYA: The implementation of the Malaysia Medical Device Authority’s (MDA) medical device regulations on July 1 is expected to augur well for the domestic medical device market according to Fitch Solutions.

It projected that the market will expand by a compound annual growth rate of 6.4% from 2019-2024 in ringgit terms or 7.4% in US dollar terms, which would see it rise to RM9.6 billion by 2024.

“We expect the market to register high single-digit growth from 2022-2024, but will see a low single digit contraction in 2021 as a result of depressed external demand from Covid-19,” said the research arm of Fitch Ratings in a report.

Beyond the impact of the pandemic, it pointed out that the market is well placed to benefit from continued government commitment, rising public health expenditure and an expanding private sector supported by medical tourism.

Furthermore, it noted that the country’s strategic geographic location and congruent operating environment will ensure the continued attraction of multinational investment.

The research house elaborated the regulation will drive standards and compliance for adverse event (AE) reporting within the current registration system and encourage stronger post-market vigilance.

Specifically, the regulations detail the requirements for reportable AEs, effective and timely device recalls and the process for field corrective and/or preventive actions by establishing the framework for recalls, reporting and record keeping.

It pointed out that the new regulation brings Malaysia closer in line with the Asean medical device directive (AMDD) which will increase market access and support regional growth in Asia.

“The new guidelines are largely aligned with the guidance set out in the AMDD, however, the MDA has expanded the procedures and outlines Malaysia-specific record- keeping requirements, specifically within record keeping,” said Fitch Solutions.

In addition, the full implementation of the AMDD will boost medical device regulations not only in Malaysia but also in participating states, as they introduce uniform systems and regulations that are up to international standards.

“This will make it easier for medical device manufacturers to market their products across the region and ensure compliance in post-market activities.”

source https://www.thesundaily.my/business/implementation-of-medical-device-regulations-to-augur-well-for-domestic-market-says-fitch-AM3178112