Malaysia. Malaysia has only 30 million people, or 12% the population of Indonesia, yet Malaysians spend more than $360 annually per person on healthcare, more than twice their per-capita spending a decade ago. The country’s total healthcare expenditure reached more than $12 billion in 2013 and is forecast to climb to almost $17 billion by 2015. Although Malaysia has significantly fewer people than Thailand and Indonesia, its medical device market, worth at $1 billion, is equal in value to the markets in these more populous countries. The device market in Malaysia is expected to nearly triple in value, to $2.7 billion, by 2018.

Malaysia has designated medical devices as a key sector for increased development and promotion. The government also identified healthcare as one of its national key economic areas in 2010. Malaysia is now investing hundreds of millions of dollars in healthcare infrastructure and clinical research. The country has more than 350 hospitals, including approximately 150 public hospitals. Domestic Malaysian medical manufacturers currently supply 80% of the world’s catheters and 60% of the world’s rubber gloves.

Until recently, Malaysia had no medical device regulations. However, in 2012 Malaysia introduced several different acts and regulations for medical devices. A new Medical Device Authority is now responsible for regulation enforcement. Following creation of Malaysia’s first comprehensive medical device registration system all imported devices must be registered and approved through the Medical Device Centralized Application System (MEDCAST) by July 2014. The online system is relatively cost-effective and efficient. Any companies that have not registered by July 2014 could see their devices taken off the market and/or face jail time and fines. Foreign device companies are now nervously scrambling to meet this deadline.

Source: Medical Device Business