Course Description:

Course "Global Medical Device Regulations - US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, Taiwan" has been pre-approved by RAPS as eligible for up to 10 credits towards a participant's RAC recertification upon full completion.

At this workshop, Dr. David Lim will walk you through to get familiar with the medical device regulations in the following twelve (12) countries.

United States EU Canada Argentina Australia Brazil
India Japan Mexico Russia South Korea Taiwan

This workshop is intended to provide guidance on medical device classification and registration requirements in these countries.

During this workshop (1st day), medical device regulations of twelve countries will be discussed.

On the second day, we will discuss ISO 13485, ISO 14155, ISO 14971, GHTF documents, and MEDDEV guidance documents, etc. for quality and adverse event reporting including group discussions facilitating interpretation, understanding, and implementation of medical device regulations.

Why Should You Attend:

Understanding global medical device regulations and requirement and adequate implementation of applicable medical device regulations can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment.

At this workshop, you will get familiar with medical device regulations of twelve (12) countries concerning medical devices, active implantable medical devices and in vitro diagnostic medical devices for adequate implementation and successful registration.

The following areas will be discussed during workshop:

  • Medical device regulations in US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, Taiwan
  • In EU, the following four Directives will be discussed.
    • DIRECTIVE 93/42/EEC Concerning Medical Devices (MDD)
    • DIRECTIVE 90/385/EEC Concerning Active Implantable Medical Devices (AIMDD)
    • DIRECTIVE 98/79/EC Concerning in vitro diagnostic medical devices (IVDD)
    • DIRECTIVE 2007/47/EC Amending MDD and AIMDD
  • ISO 13485
  • ISO 14155
  • ISO 14971
  • GHTF documents
  • MEDDEV guidance documents
    • Clinical investigation
    • Adverse event reporting

Who will Benefit:

This seminar will be valuable for anyone in the European Commission (EC) and FDA-regulated industry, including, but not limited to, medical devices, active implantable medical devices, in vitro diagnostic medical devices or combination products. This seminar will be particularly useful for those involved in research and product development, handling data and documents for regulatory submission for CE-marking purposes, conducting/monitoring/coordinating clinical investigation, and/or performing risk management and post-market vigilance/surveillance. This workshop is a must for those who are directly or indirectly involved in drafting and handling applications for CE marking purposes.

The following employees who will benefit include:

  • Regulatory affairs (associates, specialists, managers, and directors)
  • Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
  • Research and development (associates, scientists, managers, directors and VPs)
  • Product and development (associates, scientists, managers, directors and VPs)
  • Contract research organization (associates, scientists, managers, directors and VPs)
  • Site managers, and consultants
  • Senior and executive management (VPs, SVPs, Presidents and CEOs)
  • Contractors and subcontractors
  • Anyone interested!

Course Outline:

Schedule for Day 1, 9:00 AM - 4:00 PM | (EU Directives)
9:00 AM - 10:30 AM Medical Device Regulations in US and Canada
10:30 AM - 10:40 AM Short Break
10:40 AM - 12:00 Noon
  • Medical Device Regulations in EU
  • DIRECTIVE 93/42/EEC Concerning Medical Devices (MDD)
  • DIRECTIVE 90/385/EEC Concerning Active Implantable Medical Devices (AIMDD)
  • DIRECTIVE 98/79/EC Concerning in vitro diagnostic medical devices (IVDD)
  • DIRECTIVE 2007/47/EC Amending MDD and AIMDD
12:00 Noon - 1:00 PM Lunch
1:00 PM - 2:30 PM Medical Device Regulations in Argentina, Australia, Brazil, India, and Japan
2:30 PM - 2:40 PM Short Break
2:40 PM - 4:00 PM Medical Device Regulations in Mexico, Russia, South Korea, and Taiwan
Schedule for Day 2, 8:00 AM - 12 Noon | (GLP Workshop)
8:00 AM - 9:30 AM
  • ISO 13485
  • ISO 14971
  • ISO 14155
  • GHTF documents
09:30 AM - 09:40 AM Short Break
09:40 AM - 12:00 Noon
  • MEDDEV guidance documents
  • Clinical investigation
  • Adverse event reporting

Meet Your Instructor

Dr. David Lim

Dr. David Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (, Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters. Over the years, Dr. Lim has analyzed over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Currently, Dr. Lim is serving as a faculty at the Regulatory Affairs Professional Society (RAPS) and is an advisor to the Presidents and CEOs of FDA-regulated industry.

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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

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We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

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I think the material and instructor were very knowledgeable and material was excellent. The subject was well chosen and the design of presentation was most appropriate.
- QC, Regulatory affair

My colleague referred me to this event and It was good value for the price. Excellent friendly presenter and coordinator. The amount of interaction between the participants and presenters was ideal. I would also like to recommend this seminar to others.
- Regulatory Manager

I think the instructor were very knowledgeable and material was excellent. Example and templates of PMA & 510k submissions were very useful because it set the framework of how to submit a quality 510k.
- Regulatory Manager

I had very focused reason to attend this seminar: learning more about 510k, classes and requirements. The program was well organized and coordinated by ComplianceOnline.
- Quality Analyst

Dr. Lim is very knowledgeable. The amount of interaction between the participant and presenter was ideal. I would like to refer his trainings to my colleagues.
- QC, Regulatory Affairs

All the topics were well chosen and the design of the presentation was most appropriate. I like the topic “Template for Submission” most. David Lim is an excellent friendly presenter. Overall it was good value for the price with ComplianceOnline.
- Managing Director

ComplianceOnline Seminar offered a lot of valuable and relevant information. Thanks for organizing it very well and professionally. I would like to attend next seminar with in depth classification of medical device.
- Manufacturing Engineer

Speaker was great. The event was well organized and coordinated by ComplianceOnline. I would recommend this to others. Thanks!
- Attorney (Patent)


The RAPS Regulatory Affairs Certificate Program offers unique curricula to round out your regulatory knowledge and professional skills with a focus on medical devices and/or pharmaceuticals. Whether you are looking to gain a better understanding of the regulated health product industry or bolster your credibility and resume or curriculum vitae, the Regulatory Affairs Certificate Program is a valuable resource in your pursuit of professional advancement.

After completion of course "Global Medical Device Regulations - US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, Taiwan" RAPS certificate will be issued to attendee.

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