Benchmarking Regulatory Affairs in Medical Devices: Regulatory Submissions and Responsibilities

Best Practices, LLC conducted this study to establish evidence-based benchmarks on regulatory groups' activity levels for both filing and maintaining regulatory submissions in the US, China, Japan, Brazil and Canada. The study also looks at responsibilities within regulatory groups. Regulatory leaders within the medical device sector can use this study to compare their group's regulatory submission activities and levels with peer organizations.

KEY TOPICS

Regulatory Submissions & Functional Trends Benchmark Analysis
Role and Responsibility Benchmarks


KEY METRICS

Number of US Regulatory Submissions, By Type, Filed in 2014
Anticipated Change Over Next 2 Years in US Submission Trends for 9 Types of Submission Types
Number of EU, Canadian and Japanese Submissions, By Type, Filed in 2014
Anticipated Change Over Next 2 Years in EU, Canadian and Japanese Submission Trends for Various Submission Types
Number of Chinese and Brazilian Submissions, By Type, Filed in 2014
Anticipated Change Over Next 2 Years in Chinese and Brazilian Submission Trends for Various Submission Types
Number of US, EU, Japan, Canada Submissions, By Type, That Are Actively Maintained
Number of Chinese and Brazilian Submissions, By Type, That are Actively Maintained
In Past 3 Years, How Has Overall Filing Number Changed in US and High-Growth Markets
Number of Pre-Submission and Resources Required to Manage Them in 2014
Is There Currently More or Less Confidence in Approval Date Projections Than in 2013
Roles of Regulatory and Quality Functions for the Following Activities
What Are the Regulatory Affairs Experience Levels (Titles) that Can Engage with External Regulators for the Following Activities
List the Primary Responsibilities of Your Regulatory Affairs Group
Do You Have a Global IT Solution or System for the Following Activities
Note the Effectiveness of These Approaches to Monitor and Track Changing Regulatory Requirements
Who has Primary Responsibility for Publishing Regulatory Documents at Your Company


SAMPLE KEY FINDINGS

• Submission Trends:
  USA: 30-day PMAs & 510 (k) letters are highest volume filing types for most companies. On average, companies submitted 47 of 30-day PMAs and 127 510 (k) letters. Moreover, these filing types also showed highest growth with 41% for 30-day PMAs and 53% for 510(k)s.
• EU, Canada & Japan: The Japanese market has drawn many more submissions on average than the EU and Canada markets. A few companies had reverse trends – much more actively submitting filings in the EU than in Japan. Japanese market filings were growing at more than 20% per year for nearly 30-40% of respondents.
  
  METHODOLOGY

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