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Key Country Assessments
Thailand : With a population of 67 million Thailand shares borders with
Malaysia, Burma, Laos, and Cambodia. Per-capita healthcare spending in Thailand
increased from $73 in 2002 to approximately $220 in 2013. The government
sponsored healthcare scheme, although limited in coverage, has expanded to
include 99% of Thailand’s population, up from 75% coverage in 2002. The country
also has more than 850 public hospitals and almost 600 private hospitals.
The Thai medical device market is worth approximately $1 billion and is growing
15% annually. Nearly all of the top U.S. medical device manufacturers market
their products in Thailand. Because the domestic device industry primarily
produces basic products such as gloves and syringes, the country depends on
imports for higher-end devices - diagnostic imaging equipment in particular.
Thailand’s most recent medical device regulations were passed in 2008, and the
Medical Device Control Division, part of the Thai Food and Drug Administration,
is in charge of administering the regulations. Foreign companies must register
their devices according to risk. The Thai classification system divides devices
into Class III (low-risk), Class II (medium-risk) and Class I (high-risk) - the
exact opposite of the United States and EU classification frameworks.
Indonesia : Indonesia is the world’s fourth largest country by
population. It is estimated that the country’s per-capita healthcare spending
will reach almost $150 by 2015, up from $36 in 2005. The Indonesian medical
device market is worth almost $1 billion and growing at 15% annually. Almost 95%
of the market’s total value comes from imports, with 90% of all 2013 device
registrations belonging to foreign manufacturers.
The Indonesian government has also mandated increased public spending on health,
establishing a universal healthcare system and upgrading hundreds of public
hospitals. These plans are expected to grow Indonesia’s healthcare industry from
$25 billion to $50 billion by 2020. The national healthcare scheme is scheduled
to be set up by the end of 2014 and will cover all Indonesians by 2019 - though,
similar to Thailand, the coverage will be very limited. Less than two-thirds of
the country’s total population of 250 million currently has health insurance.
Unlike in other ASEAN and Asian markets, an independent third-party in Indonesia
is not allowed to hold a license on behalf of a foreign device manufacturer.
Hence, nearly all medical device licenses are held and in the name of the
Indonesian distributor, making it difficult and expensive for foreign device
companies to leave bad Indonesian distributors. Another recent reform was a new
online medical device registration system.
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.
The Philippines : With a population of 106 million, the Philippines is made up of
more than 7,000 islands. The average Filipino spent more than $100 on healthcare
last year, up from $33 annually a decade earlier. The country’s medical device
market is valued at more than $300 million and is growing at 10% annually thanks
to a growing private sector and rising healthcare spending. The market is almost
entirely composed of imports, with locally-made devices accounting for less than
3%.
Approximately 80% of all Filipinos are currently enrolled in the country’s
national health insurance system, which is primarily based on public hospitals,
mostly under the administration of the Ministry of Health. These facilities have
significant autonomy in procurement but are hampered by a severe lack of funds.
Conversely, private hospitals are much better funded, enabling them to buy
high-end devices. Heart disease is among the top causes of death in the
Philippines, as are cerebrovascular diseases and cancer.
All foreign medical devices in the Philippines must be registered. The Bureau of
Food and Drug Administration (BFAD) is the primary body governing medical
devices. Part of the Department of Health, the BFAD was created to oversee the
efficacy, quality, safety, and purity of health products. The Food, Drug, and
Cosmetic Act regulates medical devices, cosmetics, diagnostic reagents, drugs,
household hazardous substances, and food.
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