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Key Regulatory Topics: The eCTD 2014 RAPS: The Regulatory Convergence RAPS Learning Solutions RAPS Store - The source for regulatory knowledge RAPS Executive Development
Key Regulatory Topics: The eCTD
2014 RAPS: The Regulatory Convergence
RAPS Learning Solutions
RAPS Store - The source for regulatory knowledge
RAPS Executive Development

RAPS & Regulatory

RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. Read more »

 Upcoming Events
Event: Chapter

Chapter Event
Using Regulatory Intelligence in Regulatory Strategy
15 April 2014 | Indianapolis, IN

Event: Chapter

Chapter Event
Medical Device Regulatory Update
17 April 2014 | Austin, TX

Event: Webcast

Webcast
Utilizing Critical Security Controls to Secure Healthcare Technology
23 April 2014 | Online

Event: Advertising, Promotion and Labeling: the US Regulated Environment

Virtual Program
Advertising, Promotion and Labeling: the US Regulated Environment
30 April 2014 | Online

Event: RAPS Executive Development

Workshop
RAPS Executive Development
2–5 June 2014 | Evanston, IL

Event: 2014 RAPS: The Regulatory Convergence

Conference
2014 RAPS: The Regulatory Convergence
27 September–1 October 2014 | Austin, TX


» View more events

 Community
Join the discussion -- RAPS Regulatory Exchange

RE:MR Compatibility
Posted: 4/15/2014 12:40:01 PM
From : Discussion Post>>Regulatory Open Forum
Paul, 1.5 Telsa - currently the most common 3 Telsa - becoming popular Putting "MR-conditional" constitutes or should be interpreted to constitute a significant change to the labeling. Thus, it would require a new 510(k) submiss...

RE:MR Compatibility
Posted: 4/15/2014 11:13:56 AM
From : Discussion Post>>Regulatory Open Forum
Good morning Paul, I work with a group that is developing a MR-compatible device and we also do MRI-compatibility testing. Below is my intake on the issues. 1- In regards to regulation: The industry standard for MR compatibility ...

Drug Registration with ANVISA
Posted: 4/15/2014 11:01:31 AM
From : Discussion Post>>Regulatory Open Forum
Hello All, My company wants to register generic drug in Brazil (ANVISA). In order to prove equivalency with Reference drug we need to conduct BA/BE studies. I am looking for ANVISA's requirements BA/BE study. Can anyone suggest me w...

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