Global Medical Device Regulatory Strategy
57 Regulatory Affairs Professionals Society
option using available resources, showing the conse-
quences of fewer resources in understandable terms.
Often, this means shifts in market introduction tim-
ing (for this project or others), which will reduce the
revenue generated within that country or region.
Credibility is a major factor in this presentation.
To make a credible argument, the regulatory profes-
sional must provide a thorough, data-driven analysis
of why added resources are needed.
Conclusion
The following points are key to developing a global
regulatory strategy:
• The team should develop a checklist of all the
information needed, starting with business
objectives. The questions provided in this chapter
are not intended to be all inclusive. They should
be used as a guide and tailored according to the
project’s nature and subject.
Table 4-6. Summary of Regulatory Risks
Country Risk Description Mitigation
US Potential need for clinical data Clinical data have been required for
some existing products but not all. The
FDA may not accept a rationale for
why clinical data are not necessary.
Request a pre-submission meeting to
discuss the project and ascertain the
agency’s opinion.
EU Device description changes
within the directive
Recent events have triggered a review
of the rules relevant to this type of
device. There is potential for a change
in testing or design requirements.
Monitor the discussions and guidance
published by regulators.
Canada None identified N/A N/A
Mexico Slower clearance in the US will
delay initiation of the Mexico
submission and review.
Based on the regulatory plan, clearance
in the US is required prior to submit-
ting in this market.
Prepare to use an alternate regula-
tory path by engaging a distributor
with existing product approvals for a
similar product.
Brazil Laws and regulations currently
are fluctuating.
Requirements are likely to change over
the course of the project, resulting in
the need for additional test data and
the possibility of a clinical study.
Monitor legislative and regulatory
activities. Engage a local, in-country
consultant to monitor and report on
changes as they occur.
India None identified N/A N/A
China Delays in market entry Identifying an in-country representa-
tive is necessary before submission and
commercialization.
Identify the representative by the end
of January.
Table 4-5. Regulatory Submission Requirements
Country Classification Type of Submission Clinical Data Estimated Review Time
US II 510(k) No 6 months
EU III Design dossier Yes 4 months
Canada II MDL application No 2 months
Mexico II Equivalency review No 8 months
Brazil III Cadastro registration Yes 9 months
India Listed Device Device registration certificate application No 8 months
China II Registration dossier No 15 months
Japan III New device, clinical data required Yes 12 months
Australia III Design dossier and application audit No 10 months
57 Regulatory Affairs Professionals Society
option using available resources, showing the conse-
quences of fewer resources in understandable terms.
Often, this means shifts in market introduction tim-
ing (for this project or others), which will reduce the
revenue generated within that country or region.
Credibility is a major factor in this presentation.
To make a credible argument, the regulatory profes-
sional must provide a thorough, data-driven analysis
of why added resources are needed.
Conclusion
The following points are key to developing a global
regulatory strategy:
• The team should develop a checklist of all the
information needed, starting with business
objectives. The questions provided in this chapter
are not intended to be all inclusive. They should
be used as a guide and tailored according to the
project’s nature and subject.
Table 4-6. Summary of Regulatory Risks
Country Risk Description Mitigation
US Potential need for clinical data Clinical data have been required for
some existing products but not all. The
FDA may not accept a rationale for
why clinical data are not necessary.
Request a pre-submission meeting to
discuss the project and ascertain the
agency’s opinion.
EU Device description changes
within the directive
Recent events have triggered a review
of the rules relevant to this type of
device. There is potential for a change
in testing or design requirements.
Monitor the discussions and guidance
published by regulators.
Canada None identified N/A N/A
Mexico Slower clearance in the US will
delay initiation of the Mexico
submission and review.
Based on the regulatory plan, clearance
in the US is required prior to submit-
ting in this market.
Prepare to use an alternate regula-
tory path by engaging a distributor
with existing product approvals for a
similar product.
Brazil Laws and regulations currently
are fluctuating.
Requirements are likely to change over
the course of the project, resulting in
the need for additional test data and
the possibility of a clinical study.
Monitor legislative and regulatory
activities. Engage a local, in-country
consultant to monitor and report on
changes as they occur.
India None identified N/A N/A
China Delays in market entry Identifying an in-country representa-
tive is necessary before submission and
commercialization.
Identify the representative by the end
of January.
Table 4-5. Regulatory Submission Requirements
Country Classification Type of Submission Clinical Data Estimated Review Time
US II 510(k) No 6 months
EU III Design dossier Yes 4 months
Canada II MDL application No 2 months
Mexico II Equivalency review No 8 months
Brazil III Cadastro registration Yes 9 months
India Listed Device Device registration certificate application No 8 months
China II Registration dossier No 15 months
Japan III New device, clinical data required Yes 12 months
Australia III Design dossier and application audit No 10 months