|
FDA:
CFG and COFS, NSAI: ISO, MDD, EC
Firms
exporting medical devices from the United States are often asked by
foreign customers or foreign governments to supply a "certificate" for
products regulated by the Food and Drug Administration (FDA). Review of
an FDA Export Certificate is often a required part of the process to
register or import a product into another country. The FDA certificates
are:
NSAI operates under the National Standards Authority of Ireland Act,
1996 and develops and publishes standards to meet international demands
for quality, design, performance, safety and environmental impact of
products and services. Compliance with these standards is a
prerequisite to the marketing of products in many countries. The
certificates include:
-
ISO Certificate
(Certificate of Registration of Quality System)
-
MDD Certificate and Declaration of Conformity
-
EC Design Examination Certificate
Tracking
and Reporting
The major functional benefits of MEDSTAR are:
- Automate the
tracking of all correspondence with affiliate offices in foreign
countries, regulatory authorities, and manufacturing and
distribution facilities. This includes tracking date of affiliate
request and delivery of the certificate by the regulatory
department.
- Maintain an
automated list of all products covered by the certificate. Tracking
is done by manufacturing plant including all List numbers associated
with the plant's certificate and the certificate?s expiration date.
The tracking for the MDD and EC certificates includes all list
numbers associated with the certificate as well as the information
for the required periodic attachments for certification.
- All information
concerning ISO registration is maintained.
- MEDSTAR search
capabilities provides a quick method to determine which countries
market each product, which certificates are involved, and what
products are included in a certificate.
- MEDSTAR provides
for very flexible and extensive reporting. There are reports by
certificate type, by plant, by certificate expiration month and by
ISO type. All of these reports can be filtered by date range or
plant.
- The request for
the FDA CFG certificate can be created from MEDSTAR and includes the
Supplemental Information for Certification and the list of products
covered by the certificate.
Business Benefits
The major business
benefits are:
- With an
automated system, Regulatory Affairs can track expiration dates of
certificates and do the interface with the plants and affiliate
countries in order to insure compliance with international
regulations.
- Marketing in new
countries can be expedited so that compliance does not delay selling
products.
- All information
concerning International Certificates is available on-line to
department management and accurate information can be ascertained
and provided to other members of the organization.
- This manually
intensive function, when automated, will allow the personnel
responsible for international certification and compliance to focus
on the many other aspects of this job.
|
|
|
