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Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
liaison members in 2012. AHWP represents 26
member economies.13
IMDRF’s purpose is to continue GHTF’s
work, producing a series of guidance docu-
ments describing a risk-based regulatory model
to ensure medical device safety, effectiveness,
performance and quality. These guidance
documents are intended to harmonize docu-
mentation and procedures on basic regulatory
practices used to assess whether a medical
device conforms to applicable regulations in
each jurisdiction. These harmonized documents
and procedures are aimed at reducing, if not
eliminating, differences among jurisdictions,
thereby decreasing the regulatory compliance
costs and allowing patients earlier access to new
technologies or treatments. IMDRF guidance
documents reference standards,14 such as those
developed and disseminated by ISO and IEC,
a regulatory professional can implement both
within a global regulatory strategy and through-
out the medical device’s lifecycle.
Following is an example of how a global
regulatory professional may benefit from under-
standing IMDRF’s work. A manufacturer has
identified Australia as a potential target market
for its medical device and asked its global reg-
ulatory executive to determine market access
requirements. Since Australia was a founding
IMDRF member and contributed to the guid-
ance document, many standards referenced in
IMDRF documents are accepted, even if cer-
tain versions are not recognized, by Australia’s
Therapeutic Goods Administration15 (TGA).
By examining IMDRF documentation, a regu-
latory professional will be able to determine the
list of applicable standards for premarket evalu-
ation, assessment and implementation.
The same principle applies for market
access in the other IMDRF founding econ-
omies of the US, Japan, Canada and AHWP.
Guidance documents published by IMDRF
may help a medical device global regulatory
professional determine reference standards to
be used as part of the conformity assessment
process to meet different countries’ regulatory
requirements.
Using Standards to Demonstrate
Conformity With Regulatory
Requirements
While differences in medical device regulations
exist across jurisdictions, a regulatory profes-
sional may apply international standards to
demonstrate conformity to essential regulatory
elements to help get the manufacturer’s tech-
nologies and treatments to patients faster. In the
US, international standards often are referenced
in FDA guidance documents. When developing
a strategy, the regulatory professional is advised
to reference and implement these standards in
parallel with guidance documents to meet FDA
requirements, specifications and guidelines to
ensure the medical device is fit for its intended
use. For example, by utilizing the internation-
ally recognized ISO 14971 Risk Management
standard, a manufacturer can demonstrate
conformity with medical device risk manage-
ment requirements. ISO 14971 is referenced
in numerous FDA guidance documents,
including Guidance for Industry and Food and
Drug Administration Staff: Content of Premarket
Submissions for Management of Cybersecurity
in Medical Devices and Factors to Consider
When Making Benefit-Risk Determinations in
Medical Device Premarket Approval and De Novo
Classifications, which addresses the intersection
of the guidance with ISO 14971 in great detail.
As mentioned earlier, the IMDRF guid-
ance documents also reference standards,
such as ISO 14971. A regulatory professional
developing a medical device global regulatory
strategy, must apply local guidance document
recommendations, reference standards and reg-
ulations to increase chances of getting medical
technology to patients faster.
A standard is not a regulatory agency’s
recommendation or guideline presented in a
guidance document. A guidance document,
such as the FDA’s General Principles of Software
Validation Final Guidance for Industry and FDA
Staff, contains suggested regulatory guidelines
and reflects the agency’s current thinking and
recommended best practices for the medical
device regulatory process. Like IMDRF docu-
ments, FDA guidance documents may reference
numerous process, safety and performance
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
liaison members in 2012. AHWP represents 26
member economies.13
IMDRF’s purpose is to continue GHTF’s
work, producing a series of guidance docu-
ments describing a risk-based regulatory model
to ensure medical device safety, effectiveness,
performance and quality. These guidance
documents are intended to harmonize docu-
mentation and procedures on basic regulatory
practices used to assess whether a medical
device conforms to applicable regulations in
each jurisdiction. These harmonized documents
and procedures are aimed at reducing, if not
eliminating, differences among jurisdictions,
thereby decreasing the regulatory compliance
costs and allowing patients earlier access to new
technologies or treatments. IMDRF guidance
documents reference standards,14 such as those
developed and disseminated by ISO and IEC,
a regulatory professional can implement both
within a global regulatory strategy and through-
out the medical device’s lifecycle.
Following is an example of how a global
regulatory professional may benefit from under-
standing IMDRF’s work. A manufacturer has
identified Australia as a potential target market
for its medical device and asked its global reg-
ulatory executive to determine market access
requirements. Since Australia was a founding
IMDRF member and contributed to the guid-
ance document, many standards referenced in
IMDRF documents are accepted, even if cer-
tain versions are not recognized, by Australia’s
Therapeutic Goods Administration15 (TGA).
By examining IMDRF documentation, a regu-
latory professional will be able to determine the
list of applicable standards for premarket evalu-
ation, assessment and implementation.
The same principle applies for market
access in the other IMDRF founding econ-
omies of the US, Japan, Canada and AHWP.
Guidance documents published by IMDRF
may help a medical device global regulatory
professional determine reference standards to
be used as part of the conformity assessment
process to meet different countries’ regulatory
requirements.
Using Standards to Demonstrate
Conformity With Regulatory
Requirements
While differences in medical device regulations
exist across jurisdictions, a regulatory profes-
sional may apply international standards to
demonstrate conformity to essential regulatory
elements to help get the manufacturer’s tech-
nologies and treatments to patients faster. In the
US, international standards often are referenced
in FDA guidance documents. When developing
a strategy, the regulatory professional is advised
to reference and implement these standards in
parallel with guidance documents to meet FDA
requirements, specifications and guidelines to
ensure the medical device is fit for its intended
use. For example, by utilizing the internation-
ally recognized ISO 14971 Risk Management
standard, a manufacturer can demonstrate
conformity with medical device risk manage-
ment requirements. ISO 14971 is referenced
in numerous FDA guidance documents,
including Guidance for Industry and Food and
Drug Administration Staff: Content of Premarket
Submissions for Management of Cybersecurity
in Medical Devices and Factors to Consider
When Making Benefit-Risk Determinations in
Medical Device Premarket Approval and De Novo
Classifications, which addresses the intersection
of the guidance with ISO 14971 in great detail.
As mentioned earlier, the IMDRF guid-
ance documents also reference standards,
such as ISO 14971. A regulatory professional
developing a medical device global regulatory
strategy, must apply local guidance document
recommendations, reference standards and reg-
ulations to increase chances of getting medical
technology to patients faster.
A standard is not a regulatory agency’s
recommendation or guideline presented in a
guidance document. A guidance document,
such as the FDA’s General Principles of Software
Validation Final Guidance for Industry and FDA
Staff, contains suggested regulatory guidelines
and reflects the agency’s current thinking and
recommended best practices for the medical
device regulatory process. Like IMDRF docu-
ments, FDA guidance documents may reference
numerous process, safety and performance