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Singapore : Singapore is a highly developed country with a sophisticated
healthcare system. Despite having only about 5.5 million people, Singapore’s
healthcare expenditure reached nearly $13 billion in 2012, similar to total
healthcare spending in much more populous countries such as Malaysia (with 30
million people) and Thailand (with 67 million people). Per-capita healthcare
spending totaled more than $2,400 in 2013, a nearly four-fold increase over the
past decade. The country’s total medical device market was valued at $600
million in 2013.
In Singapore, 80% of primary healthcare services are covered by approximately
1900 private clinics, with 18 public polyclinics providing the remaining
coverage. The country also has seven public hospitals and six national specialty
centers. There are four tiers of reimbursement, with the government providing
large subsidies and specialized programs.
For device registration, Singapore’s Health Sciences Authority (HSA) has
developed a risk-based classification system: Class A (low risk), Class B
(low-to-moderate risk), Class C (moderate-to-high risk), and Class D (high
risk). In general, devices that have already been registered with certain
international regulatory agencies, such as the EU, Japanese PMDA, or U.S. FDA,
could qualify for an abridged, expedited, or immediate registration in
Singapore. Registration is achieved electronically, via the Medical Devices
Information and Communication System (MEDICS). Submissions must be in English,
according to the ASEAN CSDT format referenced previously.
Vietnam : Vietnam, a communist country that is becoming increasing
capitalist, is home to 93 million people. The country’s per-capita healthcare
expenditure grew from $25 in 2003 to more than $100 in 2013, and mandatory
healthcare coverage was enacted in 2009. Nearly two-thirds of Vietnamese
citizens are covered by the national healthcare system; the Ministry of Health
hopes to cover three-quarters of the population by 2015 and 90% by 2020. The
government is also investing heavily in healthcare infrastructure, while a
growing middle class is leading to expanded demand for medical devices. The
Vietnamese medical device market was worth $630 million in 2013 and is forecast
to grow about 17% annually through 2017.
Since a ban on private healthcare practice was lifted in 1989, Vietnam’s private
healthcare sector has expanded rapidly. State healthcare quality is relatively
poor, so those who can afford to use private facilities. More than 60% of
healthcare spending is made in the private healthcare sector.
In Vietnam, the Department of Medical Equipment and Health Works (DMEHW), part
of the Ministry of Health, is the main body in charge of regulating medical
devices. Domestically manufactured devices must be registered with the DMEHW,
but imported devices do not need product registration. Instead, imported devices
must have an import license.
ASEAN Countries Offer Opportunities and Risks
As the medical device markets in the BRICs become increasingly saturated, OEMs
should be focusing on the next crop of emerging medtech markets. The ASEAN
countries are an attractive option thanks to their relatively high population,
growing middle class, more frequent incidence of Western-type diseases and
increasing healthcare spend.
Still, challenges remain. While progress is being made to harmonize regulations,
each country in the ASEAN currently retains its own regulatory system.
Requirements, registration systems, and fees can vary widely from country to
country, making it difficult to establish a regulatory strategy for the region.
But hasn’t stopped many of the top medical device companies from establishing a
presence in ASEAN countries. As the region’s medtech market continues to grow,
others are likely to follow suit.
http://www.mddionline.com/article/asean-countries-could-be-next-emerging-medtech-markets
Invent Bio-Med’s Nova Vida Chrome Gets CE Certification
INVENT Bio-Med, a manufacturer for high quality Vascular Interventional Devices
in India, has recently received the Conformite Europeenne (CE) certification for
drug eluting stent (DES) - Nova Vida Chrome, from EVPU as.
Ravi Shankar Srivastava, chairman and managing director and Shardul Srivastava,
vicepresident, Invent Bio-Med, Confirmed that it is the fourth company in India
to have CE certificate from EVPU for this kind of Class III product.
They further added that our quality policy is to manufacture and market high
quality interventional cardiovascular medical devices of requisite standards
with customer focused activities. We are highly comply with the requirements to
maintain the effectiveness of the quality management system as per MDD
Directives.
Invent Bio-Med is delighted to manufacture such high quality device for
cardiovascular use in India, Europe and rest of world. The CE mark for Nova Vida
Chrome stent is a significant achievement for the company.
(Ref: The Chronicle Pharmabiz dated Jan 30, 2014)
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