Half of the global elderly population lives in Asia, and that share will rise to
more than 60% by 2050. In Southeast Asia, the percentage of people over age 65
will more than quadruple by 2050. As people age they have significantly more
orthopedic problems. A December 2013 report by the International Osteoporosis
Foundation indicated that the number of people at high risk for osteoporosis in
the Philippines will reach four million by 2020 and reach 10.2 million by 2050.
Also by 2050, more than seven million Vietnamese women will be at risk of
developing osteoporosis.
To increase market share, several Western
orthopedic device companies have set up local production
facilities to make lower cost, more basic versions of their
high-end orthopedic devices. Alternatively, other Western firms
have acquired local orthopedic device companies with broad
portfolios and good market shares, increasing their
competitiveness in mid-range products.
Cardiovascular disease is the leading cause of
death in several Asian countries. Almost 60% of the 17 million
annual cardiovascular-disease-related deaths occur in Asia. An
increasing focus on preventing, diagnosing, and treating
cardiovascular issues has resulted in an increased demand for
cardiac devices. An estimated 25-30% of deaths in Southeast Asia
are caused by cardiovascular disease. In Malaysia, approximately
half of those over the age of 30 have hypertension.
Some foreign cardiovascular firms are also
developing cardiac technology centers, manufacturing sites, and
R&D facilities. For instance, several years ago, Medtronic set up
a new facility to manufacture cardiac devices in Singapore, taking
advantage of large government tax breaks.
Every year, more than six million Asians are
diagnosed with cancer, and four million die from the disease.
Among new cases of cancer globally, half are in Asia. The ASEAN
nations are also |
Sourcing from ASEAN Countries
Besides selling their device products in ASEAN
countries, an increasing number of Western medical device
companies are also manufacturing or sourcing their products there.
They are doing so for a variety of reasons,
including Asia’s low overhead costs, low labor costs, and
improving technical capabilities. While labor costs have increased
significantly in China, they remain low in some of the ASEAN
countries, including Vietnam.
For medical device sourcing and manufacturing,
Vietnam has long been considered a poor second choice to China
because of the country’s complicated government oversight and
inadequate infrastructure. However, there have been significant
advances in Vietnam since the mid-2000s. Improving technical
capabilities and a large, hard-working labor force are making it
easier for Western companies to collaborate with Vietnamese device
manufacturers.
Although ASEAN countries have traditionally
been known for low-end medical device product manufacturing, such
as simple catheters and drainage bags, this is no longer the case.
Some manufacturers in ASEAN countries are now able to produce more
sophisticated Class II and, in some cases, Class III medical
devices. |
experiencing increasingly high cancer rates. The most common
cancers in Southeast Asia are lung, breast, liver, and colorectal cancers. The
causes include high rates of Hepatitis B, smoking, alcohol use, red meat
consumption, air pollution, and genetic factors. Nasopharyngeal (nose) cancer,
relatively rare in the West, is increasingly common in Asia.
Many Western device firms are expected to increase their
sales of cancer diagnostic and treatment products in ASEAN nations.
Medical Device Regulatory Standards in ASEAN Countries
The unpredictable regulatory situation has been one of the biggest hurdles for
foreign medical device companies doing business in the ASEAN countries. Issues
such as product registration, quality control and postmarket surveillance are
often different in each country or simply do not exist.
To address this variation in regulations, the ASEAN Consultative Committee on
Standards and Quality (ACCSQ) created the Medical Device Product Working Group (MDPWG)
in 2004. The MDPWG’s most recent draft regulations, called the ASEAN Medical
Device Directive (AMDD), were released in 2012 and are expected to be
implemented by the end of 2014.
The AMDD provides a harmonized regulatory model for member countries, outlining
the basic requirements for medical device performance and safety, conformity
assessments, a risk-based classification system and the Common Submission
Dossier Template (CSDT). The classification system, based on Global
Harmonization Task Force (GHTF) guidelines, consists of four medical device
categories:
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Class A includes low-risk devices, such as tongue depressors.
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Class B includes low-to-moderate-risk devices, such as hypodermic needles.
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Class C includes moderate-to-high-risk devices, such as lung ventilators.
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Class D includes high-risk devices, such as heart valves.
This classification system also applies to in-vitro diagnostics (IVDs).
Government fees, clinical requirements, and processing approval timeframes vary
in ASEAN countries, depending on the classification. Furthermore, each country
can develop its own expedited registration process under the AMDD. Many ASEAN
nations are likely to follow Singapore’s lead in implementing the AMDD
directives.
Until the AMDD framework is implemented, however, each nation retains its own
regulatory system.
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