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ASEAN Medical Device Harmonization Update
While many details of the AMDD are left to member countries,
the important details of classification and data requirements are the same for
every country in the ASEAN region. Although this will place an additional burden
on foreign device manufacturers selling to countries like Cambodia (which
formerly had no system for registering medical devices), it will also,
hopefully, establish a common registration system and reduce uncertainty in the
market. Further, the AMDD may open the door to other forms of regulatory
integration within ASEAN, such as integrated abridged registration processes and
common product approval procedures.
The ASEAN market for medical devices is fairly
under penetrated and is expected to double from $4 billion in 2012, to $8 billion
by 2017. The Association of Southeast Asian Nations (ASEAN) consists of ten
member countries with a combined GDP of $2.3 trillion and a population of 620
million. The region comprising of 10 member countries, namely Brunei, Cambodia,
Indonesia, Laos, Malaysia, Myanmar (Burma), the Philippines, Singapore, Thailand
and Vietnam, was the only region in the world to post higher economic growth in
2012 than in 2011 (economic growth for 2012 was 5.3 percent in ASEAN, compared
to 2.2 percent in the US and negative 0.3 percent in the EU).
The economic boom has boosted per capita income from Malaysia
to the Philippines, and it has also led to the rapid rise of a middle class. In
2010, ASEAN’s middle class made up 24 percent of its total population. If
current rates hold, the middle class is expected to make up 65 percent of
ASEAN’s total population by 2030. As the middle class has grown, so has demand
for more and better quality medical devices. In 2012, the total value of the
ASEAN medical device market was more than $4 billion. This is expected to
increase to $8 billion by 2017.
But unlike mature markets in the EU and Japan, ASEAN’s
market for medical devices is significantly under-penetrated. This will mean
many opportunities for foreign medical device companies that can navigate the
ASEAN regulatory environment.
The Asean Medical Device Directive
One of the biggest challenges to foreign medical device companies doing
business in Southeast Asia has been the unpredictable regulatory environment for
medical devices. Standards for product registration, distribution and
post-market surveillance have varied significantly from country to country, and
in some cases (Cambodia, Laos, Brunei and, until recently, Malaysia) have not
existed at all.
To unify standards in the medical device industry, the ASEAN
Consultative Committee on Standards and Quality (ACCSQ) set up the Medical
Device Product Working Group (MDPWG) in 2004. The MDPWG was tasked with putting
together a harmonized set of standards for medical device registration and
post-market surveillance throughout the ASEAN region.
The MDPWG’s most recent draft regulations – the ASEAN Medical
Device Directive (AMDD) – came out in 2012, and implementation is expected by
December 2014. The AMDD lays out basic requirements for a harmonized
classification system, medical device safety and performance, conformity
assessments and a Common Submission Dossier Template (CSDT).
The AMDD is not a legally binding document, but instead acts
as a model for member nations, much like the EU Medical Device Directive. The
current AMDD was developed with input from member countries, industry
representatives and international regulatory bodies like the Global
Harmonization Task Force (GHTF) and the World Health Organization (WHO).
Medical Device Classification
The AMDD sets up a risk-based classification system based on
GHTF guidelines. According to the AMDD, medical devices – including in-vitro
diagnostics (IVDs) – will fall into one of four categories:
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Class A (low risk
devices like tongue depressors)
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Class B (low-moderate
risk devices like hypodermic needles)
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Class C
(moderate-high risk devices like lung ventilators)
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Class D (high risk
devices like heart valves)
Classification determines fees, processing times and clinical
requirements.
Product Registration
Under the proposed AMDD, all member countries must establish
an AMDD compliant system for assessing medical devices. According to the current
draft, conformity assessments may be carried out by the main regulatory body of
member state itself, or by a third party appointed by the member state.
Additionally, all product registration applications should be
submitted by an in-country representative of the device manufacturer. If the
manufacturer does not have an office in a particular member country, then it
must appoint a local agent as its authorized representative.
Common Submission Dossier Template
The Common Submission Dossier Template (CSDT) guidelines are
the most significant part of the AMDD, as they lay out requirements for all data
to be included in medical device registration. The CSDT eliminates the need to
prepare multiple dossiers in different formats for each of the ASEAN countries.
Application information includes:
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An executive summary
(including a commercial marketing history of the medical device and a list of
regulatory approval or marketing clearances already obtained)
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An Essential
Principles conformity checklist
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A device description,
including intended use and indications, instructions for device use, warnings
and precautions, potential adverse effects, alternative therapy and materials
and relevant specifications
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Design validation and
verification documents (such as engineering and biocompatibility tests),
including the results of pre-clinical and clinical studies, software validation
and verification studies, clinical evidence and relevant bibliography references
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Samples of device
labeling and packaging and instructions for use
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Risk analysis
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Manufacturer
information (including details on the manufacturing process)
Post-Marketing Alert System
In addition to setting up pre-market requirements, the AMDD
also sets forth a list of documentation requirements for complaints and adverse
events.
(By Ames Gross, Pacific Bridge Medica Web Link :
http://medicaldevicesummit.com/Main/Features1/ASEAN-Medical-Device-Harmonization-Update-1467.aspx)
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