RAPS has arrived in Asia. Regulatory Basics Bundle RAPS Online University: Medical Devices - China, Japan, Singapore and South Korea Regulation Overview
RAPS has arrived in Asia.
Regulatory Basics Bundle
RAPS Online University: Medical Devices - China, Japan, Singapore and South Korea Regulation Overview

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 »

Launching in Singapore in 2014

Graduate Certificate in Medical Device Regulatory Affairs

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Advance Your Career. Be a RAPS Member.

Access the collective expertise of your peers. Join the largest global community of regulatory professionals and get exclusive access to news, career resources and discounts. Members in emerging economies enjoy a reduced rate.

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Further Savings for Emerging Markets Members

Members from emerging markets enjoy reduced membership dues and further discounts for professional resources and events. Find out now if you are eligible.

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 Regulatory News

Read more about these stories and get all the latest regulatory news and information by visiting the new all-digital Regulatory Focus.

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Brazil Expedites Device Imports

Brazil’s national regulatory agency, Anvisa, has expedited the process for importing high-risk medical devices (Class III and IV) by agreeing to review devices as soon as its foreign manufacturing Read more »

EMA Set to Finalize Clinical Trials Transparency Policy

The European Medicines Agency (EMA) announced on 8 April 2014 that it plans to launch a final round of meetings in May with organizations representing patients, academia, the pharmaceutical industry Read more »

Health Canada Overhauls Product Monograph Guidance

Health Canada issued revised product monograph guidance on 4 April 2014 that sets forth new design and format requirements, and also includes a new section on preparing patient information. According Read more »

China Announces Major Overhaul of Device Regulation

On 31 March 2014, the China Food and Drug Administration (CFDA) and China's State Council Legislative Affairs Office announced the first major overhaul of the regulations governing medical devices Read more »

 Community
Join the discussion -- RAPS Regulatory Exchange

RE:Risk-Based Biocompatiblity Assessment Timeframes?
Posted: 4/19/2014 1:32:46 PM
From : Discussion Post>>Regulatory Open Forum
I'm afraid I didn't ask my question very clearly, for which I apologize. For people with experience with ISO 10993 risk-based biocompatiblity assessment with new devices, I would like to know about how much PROJECT time it takes to g...

RE:Career Advice
Posted: 4/18/2014 3:19:35 PM
From : Discussion Post>>Regulatory Open Forum
I would say that one of the best and fastest ways is to keep plugging with other professionals while building and sharpening your skills and knowledge. While doing so, if you are able to develop these three key attributes (I wrote...

RE:Risk-Based Biocompatiblity Assessment Timeframes?
Posted: 4/18/2014 8:58:01 AM
From : Discussion Post>>Regulatory Open Forum
Julie: We do lots of these for device clients. Once you have the chemical portion of the L & E assessment (what comes out of a device upon appropriate extractions and how much of each such moiety per device), the risk assessme...

 Conferences and Events
Event: AHWP & RAPS Joint Conference

Workshop
AHWP & RAPS Joint Conference
2–3 December 2013 | Kuala Lumpur, Malaysia

Event: Webcast

Webcast
China Medical Device Market Entry: Strategies for Success in Testing and Recent Regulatory Changes
18 December 2013 | Online

Event: RAC Autumn Exam

Certification Events
RAC Spring 2014 Exams
1 April–31 May 2014

Event: 2014 RAPS: The Regulatory Convergence

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


» View more events

Become a Member

Regulatory Focus Online

Regulatory Focus Breaking global regulatory news and in-depth expert insight.

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International Affiliates

RAPS International Affiliates provide a local forum for regulatory professionals to share experiences and interact with colleagues. Learn more about where RAPS currently has International Affiliates and how to start one in your area.

In the RAPS Store

Fundamentals of International Regulatory Affairs, First EditionFundamentals of International Regulatory Affairs, Second Edition
The perfect reference tool for any regulatory affairs professional working internationally.

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Contact RAPS Pan-Asia Office

Regulatory Affairs Professionals Society (RAPS) Pan-Asia
20 Bendemeer Road
#04-02 Cyberhub
Singapore 339914
Phone: +65 6496 5507
Email: jlye@raps.org