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South
Korea’s move toward device regulation started with the
Medical Devices Act (MDA), which was developed in 2003
and went into effect May 30, 2004. However, it is
still in a transition period—full enforcement of the
MDA begins May 30, 2007. The MDA provides for the
independent regulation and safety management of
medical devices and aims to harmonize Korea’s medical
device regulations with international standards.
Medical
Devices in Korea is regulated by Korea Food & Drug
Administration (KFDA), the national regulatory
authority. All devices required to obtain KFDA product
license or product approval. KFDA only issues product
licenses to local firms; foreign firms must submit
documentation and receive approval through a Korean
importer. Korean importers must maintain qualification
certifications (“Certifications of Compliance to
Quality Management System (QMS) for Imported Devices”)
issued by a KFDAauthorized entity.
Also,
Korea does not allow devices into the country that
have not been approved in their country of
manufacture. A Certificate to Foreign Government or
Free Sale Certificate is an integral part of a foreign
product’s application.
Devices
are divided into four classes, Class I being lowest
risk and Class IV being highest risk. There is a
strict system of over 1,000 classifications dividing
devices up into those four classes, although there are
plans to expand the number of classifications to a new
total of about 2000 more-detailed
classifications.Review of applications for product
licenses must be completed in 55 days.
There
are three processes required to get a device
registered in Korea: a product license; Korean Good
Manufacturing Practice (KGMP) certification; and a
Device Business License. Of these, the KGMP
certification must be renewed every three years. The
other two are valid permanently, although changes may
require re-registration. Once these three licenses
have been obtained it is finally legal to market a
medical device in Korea. Beyond regulatory permission,
there are other important processes as well, such as
obtaining reimbursement from Korea’s national health
insurance system, as well as post-market surveillance
requirements.
The two
main requirements for a product license are a
technical file and type testing.
Device
Business License is similar to the US Certificate of
Device Establishment, can be obtained by submitting
one Product License and other information on the
company (facilities, business registration, and health
certificate for its representative). It does not
expire. Of course, an importer will typically have
such a license already for other products.
A company applies for KGMP certification by way of a
third-party inspection organization. This organization
does not do the entire inspection, but assists the
KFDA inspectors in much of their work. The process
takes about one month from application, and costs
about $1,000, depending on the size of the company.
The certificate is valid for 3 years. In the case of
foreign manufacturers without an office in Korea, only
the importer undergoes inspection, but it needs
documentation from foreign manufacturers to
demonstrate its compliance. Some token manufacturing
or importing must be done to produce a paper trail
demonstrating compliance, even if the device cannot be
sold yet. |
Device Regulatory Environment
Medical
devices do not have to be registered in Singapore,
except for contact lens products, radiation-emitting
devices, and condoms, which come under statutory
control through provisions of the Contact Lens
Practitioners Act, the Radiation Protection Act, and
the Medicine Act, respectively. The Health Sciences
Authority (HSA) is the regulatory authority, and the
Center for Medical Device Regulation (CMDR) is
responsible for regulating medical devices in
Singapore.
The
Voluntary Product Registration Scheme, launched in
2002, encourages local authorized representatives of
medical device companies to register their products
with CMDR. The project targets medium- and high-risk
medical devices in Classes IIa, IIb, and III, and IVDs
in List A, List B, and self-testing categories.
The
voluntary registration constitutes a premarket
application made to HSA before the device is placed on
the Singapore market. Evidence of the safety and
effectiveness of any Class IIa, IIb, or III device or
List A, B, or self-test IVD should be submitted to HSA.
The
Singapore Medical Device Register is a database of
medical devices that are imported into or exported
from Singapore. Manufacturers should submit
information on the quality, safety, and efficacy of
their devices (though listing in the register is
voluntary).
CMDR
first reviews the submitted information using
standards that satisfy the regulatory requirements of
developed countries in making its premarket
assessment. The objective is for hospitals and clinics
to use the register to purchase listed devices that
meet those regulatory standards. CMDR will also use
its database to monitor the postmarketing activities
of medical device companies.
CMDR
and HSA have developed the Medical Device Information
& Communication (MEDICS@HSA) system. MEDICS is a
Web-based system that provides an electronic
environment for interaction between medical device
establishments and the regulatory authority.
Currently, users can access several key documents
through MEDICS, including the establishment license
application, the market clearance application for
higher-risk devices, the notification of export-only
unregistered medical devices, and more. More
information is available at www.hsa.gov.sg. |
