2 Day Seminar Product Registration and Navigating the Approval Process with Regulatory Authorities in Asia Pacific, Europe, Middle East and The Americas

By: David R Dills, Regulatory Affairs & Compliance Consultant.
Product code: SEM16
Location 1: Chicago Apr 25 - 26

Description

Each attendee will receive 2-Day workshop materials ,Certificate, Complimentary Breakfast , Lunch & High Tea/Coffee provided by WCS. 

Course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Although China’s medical regulatory bodies are becoming more harmonized with international standards, the Chinese registration process still poses significant difficulties for Western medical device and pharmaceutical firms. Learn how prepare the necessary documents and register your product with the Chinese regulatory authorities. As a special administrative region of China, Hong Kong has its own medical device regulations, separate from the mainland. While Hong Kong had little legislative control over the import of medical devices in the past, recent changes to Hong Kong’s medical device registration system have led to stricter requirements. The Indian medical regulatory system has become more complicated in recent years. In the past, medical devices did not need to be approved at all, but that is not the case today. In India, there are about 30 device “families” that outline which specific medical devices need to be registered. Registration of medical devices in Japan is complicated, costly, and will generally take between 1-3 years depending on the device classification. In some cases, Japanese regulators require clinical trials in Japan to be conducted, and the costs of these trials can be very high. Product registration in Japan needs to be pursued carefully and only after determining that there is a strong market demand for your product. South Korea’s medical regulatory system can be complicated for Western medical device manufacturers due to its increasingly strict requirements and Korea’s unique business culture. Learn the process and determine the necessary documents and submitting your application to the Singaporean medical device regulatory authorities. The complexity level of Taiwan’s medical device registration process is comparable to that of Japan’s and China’s registration processes, though somewhat simpler. In certain cases, U.S. or EU approvals can be substituted for local requirements. In addition, Taiwan’s government has recently been overhauling the approval system to improve its efficiency. Before any medical device can be supplied in Australia, the device must be included in the Australian Register of Therapeutic Goods (ARTG) which is regulated by the Australian Therapeutic Goods Administration (TGA).

Canada

The Canadian Medical Device License (MDL) is required for companies selling Class II, III, or IV medical devices in Canada. The MDL is a product approval, while a MDEL is a permit for the company/distributor/importer itself. Canada's Medical Devices License (MDL) is comparable to the US FDA 510(k) process.

United States

One of the first steps towards selling a Class II medical device or IVD in the United States is to file a Premarket Notification with the FDA, also known as an FDA 510(k) submission. Technically, the FDA does not "approve" medical devices or IVDs for sale under the 510(k) process; the agency gives "clearance" for them to be sold in the U.S. We use the term "FDA approval" for simplicity. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Mexico

Mexico is the second largest medical device market in Latin America behind Brazil, and can prove to be a profitable target for medical device and IVD manufacturers. However, registering a device or IVD in Mexico can be challenging. COFEPRIS, the division of the Mexican Ministry of Health (Secretaría de Salud) is responsible for medical device and IVD oversight.

South America

Medical devices in Brazil are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA). Brazil’s base regulations and medical device classification schemes are similar to those found in the European MDD 93/42/EEC. Commercializing your medical device for sale in Peru requires registration with DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), the country’s medical device regulator. DIGEMID currently does not have a formal classification system in place, so a device’s classification in its country of origin is usually accepted by Peruvian regulators. A four-tier classification system is currently under consideration by the Peruvian government.

Europe

In order to sell medical devices and IVDs in the European Union, you must first CE Mark your product. The CE Mark is not a quality mark, nor is it intended for consumers. CE marking indicates to EU regulators that your device meets all applicable requirements of the appropriate EU Directive, such as the Medical Devices Directive (MDD), In Vitro Diagnostic Device Directive (IVDD) or Active Implantable Medical Device Directive (AIMD), as they apply to your product.

Israel

Gaining access to the Israeli medical device market—one of the largest in the Middle East—requires registering your device with AMAR, the Israeli Ministry of Health’s medical device regulation unit. Medical device registration in Israel is based having prior approval in one of the five founding Global Harmonization Task Force (GHTF) countries: Australia, Canada, Europe, Japan, or the United States. Manufacturers that have already obtained approval for their devices in those markets can leverage those registrations to satisfy most of Israel’s medical device regulatory approval requirements.

Turkey

All medical devices imported into Turkey are required to have European CE marking. The classification of medical devices is the same used in the EU. Medical devices in Turkey are governed by the General Directorate of Pharmaceuticals and Pharmacy Department of Medical Device Services. The regulation covering medical devices is the Turkish Medical Devices Directive, which uses the framework of the EU Medical Devices Directive (MDD) 93/42/EEC.

Areas Covered

  • Get assistance with medical device registration and medical device approval
  • Learn how to access new markets and obtain medical device approval in all the countries listed
  • Complete your registration in order to obtain medical device approval as efficiently as possible while realizing that some markets/countries will be more challenging
  • Navigate the regulatory system, achieve product registration, and access the medical market
  • In a group setting, review and discuss pain points, challenges and workable regulatory and compliance solutions

 

Who will Benefit

This seminar will provide an overview and in-depth snapshot of the product registration and approval process for Asia Pacific, Europe, Middle East, United States, Canada, Mexico and South America. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the registration and approval process in select countries, including:

  • Regulatory Affairs Management
  • Regulatory Affairs Specialist
  • Auditors
  • Compliance Officer
  • Compliance Specialist
  • Clinical Affairs
  • Quality Assurance Management
  • Marketing & Sales
  • Distributors/Authorized Representatives
  • Legal Counsel
  • Engineering/Technical Services
  • Operations/Manufacturing
  • Consultants

 

Learning Objectives

David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape.

Course Outline:

09:00 AM - 06:00 PM

Day 1: 

Breakfast/Registration: 8-9 am
Start Time: 9 am
Break: 10:15-10:30 am/3:00-3:15 pm
Lunch: Noon (1 hour)
Adjourn/Wrap-Up: 6 pm
Topics: China, Japan, Australia, South Korea, Singapore, Hong Kong, Taiwan

  • Which regulatory bodies in the Chinese government are responsible for medical device registration in China?
  • In China, are medical devices required to be registered before they can be sold?
  • What are the different regulatory classifications for medical devices?
  • What does the registration pathway look like for each regulatory classification?
  • What are the document requirements for registration for each regulatory classification?
  • Is local testing (type testing/sample testing) required for registration?
  • When are clinical studies required for registration?
  • Is approval in the Country of Origin required for registration?
  • In Hong Kong, are medical devices required to be registered before they can be sold?
  • What are the advantages of registering for voluntary listing?
  • What are the different regulatory classifications for medical devices?
  • What does the registration pathway look like for each regulatory classification?
  • What are the document requirements for registration?
  • Is local testing (type testing/sample testing) required for registration?
  • Are clinical studies required for registration?
  • Is approval in the Country of Origin required for registration?
  • In India, are medical devices required to be registered before they can be sold?
  • What are the different regulatory classifications for medical devices?
  • What does the registration pathway look like for regulated medical devices?
  • Is local testing (type testing/sample testing) required for registration?
  • Are clinical studies required for registration?
  • Is approval in the Country of Origin required for registration?
  • Which regulatory bodies in the Japanese government are responsible for medical device registration in Japan?
  • In Japan, are medical devices required to be registered before they can be sold?
  • What are the different regulatory classifications for medical devices?
  • What are the different application categories for medical device registration?
  • What does the registration pathway look like for each regulatory classification?
  • What are the document requirements for notification for Class I medical devices?
  • What are the document requirements for registration for Class II medical devices?
  • What are the document requirements for registration for Class III and IV medical devices? What are other requirements that are necessary for approval in addition to the device application?
  • Is local testing (type testing/sample testing) required for registration?
  • When are clinical studies required for registration?
  • Is approval in the Country of Origin required for registration?
  • Which regulatory bodies in the Korean government are responsible for medical device registration in Korea?
  • In Korea, are medical devices required to be registered before they can be sold?
  • What are the different regulatory classifications for medical devices?
  • What does the registration pathway look like for each regulatory classification?
  • What are the document requirements for registration for each regulatory classification?
  • Is local testing (type testing/sample testing) required for registration?
  • When are clinical studies required for registration?
  • Is approval in the Country of Origin required for registration?
  • Which regulatory bodies in the Singaporean government are responsible for medical device registration in Singapore?
  • Which regulatory organizations are considered independent reference agencies by the HSA?
  • In Singapore, are medical devices required to be registered before they can be sold?
  • What are the different regulatory classifications for medical devices?
  • What does the registration pathway look like for Class A medical devices?
  • What does the registration pathway look like for Class B-D medical devices?
  • What are the document requirements for registration for each regulatory classification?
  • Assess the Australian TGA registration requirements for your device(s).
  • Research the proper GMDN codes for your medical device(s) in Australia.
  • Conduct a Technical File review to ensure completeness, review of clinical summary (a TGA requirement) and file documentation with the TGA.
  • Determine the classification of your medical device according to Schedule 1 of the Canadian Medical Devices Regulations (CMDR) and knowing that devices fall into Class I, Class II, Class III or Class IV.
  • Prepare 510(k) premarket notification and PMA (Premarket Approval) submissions for US FDA.
  • Classify your device, choose the correct Premarket Submission and prepare the appropriate information for your Premarket Submission to the FDA.
  • Determine the proper regulatory pathway for your devices andthe documentation required within the applicable registration route for Mexico.
  • Determine classification of your medical device or IVD and determine a grouping strategy for your registration in Mexico and prepare and submit registration application documents to COFEPRIS.
  • Determine the proper regulatory pathway for your devices and the documentation required within the applicable registration route with ANVISA in Brazil.
  • Certain devices require INMETRO Certification in Brazil.
  • For all classes, ANVISA reviews registration application and upon approval, ANVISA will publish registration number in the Diario Oficial da Uniao (DOU).
  • Prepare a CE Marking Technical File or a Design Dossier (for a Class III device) that includes data demonstrating compliance with the applicable directives (MDD, IVDD, AIMD) in Europe.
  • Medical device and IVD CE Marking Technical File or Design Dossier compilation and review.
  • Verification of Essential Requirements and Europe.
  • Implementation, modification and maintenance of a quality system (usually ISO 13485) that will meet European and other international requirements for Europe.
  • Appoint an authorized representative in Israel to interact with AMAR on your behalf and manage your application process.
  • Additional Requirements for Obtaining Medical Device Approval in Israel.

 

09:00 AM - 04:30 PM

Day 2: 

Breakfast/Registration: 8-9 am
Start Time: 9 am
Break: 10:15-10:30 am/3:00-3:15 pm
Lunch: Noon (1 hour)
Adjourn/Wrap-Up: 4 : 30 pm
Topics: US, Canada, Mexico, Europe, Israel, Brazil

  • Which regulatory bodies in the Chinese government are responsible for medical device registration in China?
  • In China, are medical devices required to be registered before they can be sold?
  • What are the different regulatory classifications for medical devices?
  • What does the registration pathway look like for each regulatory classification?
  • What are the document requirements for registration for each regulatory classification?
  • Is local testing (type testing/sample testing) required for registration?
  • When are clinical studies required for registration?
  • Is approval in the Country of Origin required for registration?
  • In Hong Kong, are medical devices required to be registered before they can be sold?
  • What are the advantages of registering for voluntary listing?
  • What are the different regulatory classifications for medical devices?
  • What does the registration pathway look like for each regulatory classification?
  • What are the document requirements for registration?
  • Is local testing (type testing/sample testing) required for registration?
  • Are clinical studies required for registration?
  • Is approval in the Country of Origin required for registration?
  • In India, are medical devices required to be registered before they can be sold?
  • What are the different regulatory classifications for medical devices?
  • What does the registration pathway look like for regulated medical devices?
  • Is local testing (type testing/sample testing) required for registration?
  • Are clinical studies required for registration?
  • Is approval in the Country of Origin required for registration?
  • Which regulatory bodies in the Japanese government are responsible for medical device registration in Japan?
  • In Japan, are medical devices required to be registered before they can be sold?
  • What are the different regulatory classifications for medical devices?
  • What are the different application categories for medical device registration?
  • What does the registration pathway look like for each regulatory classification?
  • What are the document requirements for notification for Class I medical devices?
  • What are the document requirements for registration for Class II medical devices?
  • What are the document requirements for registration for Class III and IV medical devices? What are other requirements that are necessary for approval in addition to the device application?
  • Is local testing (type testing/sample testing) required for registration?
  • When are clinical studies required for registration?
  • Is approval in the Country of Origin required for registration?
  • Which regulatory bodies in the Korean government are responsible for medical device registration in Korea?
  • In Korea, are medical devices required to be registered before they can be sold?
  • What are the different regulatory classifications for medical devices?
  • What does the registration pathway look like for each regulatory classification?
  • What are the document requirements for registration for each regulatory classification?
  • Is local testing (type testing/sample testing) required for registration?
  • When are clinical studies required for registration?
  • Is approval in the Country of Origin required for registration?
  • Which regulatory bodies in the Singaporean government are responsible for medical device registration in Singapore?
  • Which regulatory organizations are considered independent reference agencies by the HSA?
  • In Singapore, are medical devices required to be registered before they can be sold?
  • What are the different regulatory classifications for medical devices?
  • What does the registration pathway look like for Class A medical devices?
  • What does the registration pathway look like for Class B-D medical devices?
  • What are the document requirements for registration for each regulatory classification?
  • Assess the Australian TGA registration requirements for your device(s).
  • Research the proper GMDN codes for your medical device(s) in Australia.
  • Conduct a Technical File review to ensure completeness, review of clinical summary (a TGA requirement) and file documentation with the TGA.
  • Determine the classification of your medical device according to Schedule 1 of the Canadian Medical Devices Regulations (CMDR) and knowing that devices fall into Class I, Class II, Class III or Class IV.
  • Prepare 510(k) premarket notification and PMA (Premarket Approval) submissions for US FDA.
  • Classify your device, choose the correct Premarket Submission and prepare the appropriate information for your Premarket Submission to the FDA.
  • Determine the proper regulatory pathway for your devices andthe documentation required within the applicable registration route for Mexico.
  • Determine classification of your medical device or IVD and determine a grouping strategy for your registration in Mexico and prepare and submit registration application documents to COFEPRIS.
  • Determine the proper regulatory pathway for your devices and the documentation required within the applicable registration route with ANVISA in Brazil.
  • Certain devices require INMETRO Certification in Brazil.
  • For all classes, ANVISA reviews registration application and upon approval, ANVISA will publish registration number in the Diario Oficial da Uniao (DOU).
  • Prepare a CE Marking Technical File or a Design Dossier (for a Class III device) that includes data demonstrating compliance with the applicable directives (MDD, IVDD, AIMD) in Europe.
  • Medical device and IVD CE Marking Technical File or Design Dossier compilation and review.
  • Verification of Essential Requirements and Europe.
  • Implementation, modification and maintenance of a quality system (usually ISO 13485) that will meet European and other international requirements for Europe.
  • Appoint an authorized representative in Israel to interact with AMAR on your behalf and manage your application process.
  • Additional Requirements for Obtaining Medical Device Approval in Israel.

 

speaker

David R DillsRegulatory Affairs & Compliance Consultant

David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provid

Seminar One Registration
$ 991
25-Apr,2017 Chicago


Special Group Discount Register for Four attendees
$ 3695

Please call any of our customer support on 844-267-7299 to avail the below discount for your Group

2 Attendees - 2% off

3 to 6 Attendees - 5% off

7 to 10 Attendees - 10% off

10+ Attendees - 15% 0ff

Register To Buy

Other Modes of Payment

Want to register by Wire Transfer?
Please call any of our customer support on 844-267-7299 to help you completed the transfer.

Want to register by check or PO?
Please call any of our customer support on 844-267-7299 or drop any email to help you completed the purchase.

Download Registration Form

Yes, I want to attend this Seminar

Click here to Download Registration Form

DoubleTree by Hilton O’Hare – Rosemont

5460 North River Road, Rosemont, IL 60018

Call our customer care to get the discounted rate Toll Free 844-267-7299

How to Reach

Testimonials

I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer
 

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.

 

“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals

 

“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.


“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.

 

Media Partners

Top Media Partners and Sponsors World Compliance Seminars WCS


speaker

Morf Media, Inc. is shaping the future of enterprise compliance training for the mobile workforce. For the first time, a digital compliance training system, Morf Learning™, provides one to one training to millions on a smart phone or tablet. Now in pilot with more than 100 major companies in the financial services and life sciences industries, Morf Learning is proving to be cost-effective and engaging. Morf Learning delivers three-minute mini lessons with a personalized Virtual Coach™ developed using the Octalysis framework designed by world-renowned gamification leader, Yu-Kai Chou. 


speaker

Benefits of enrolling for Media Partner

Your company Logo on all the mailings before and after the event.

Get 10% discount to media partner's subscribers.

Publish your Logo and company data on the event website.

Publish your Logo on the conference material distributed during the conference.

Media Partner’s brochure distributed along with conference material


speaker

MEDIA PARTNERS WORK TO DO

Publish Banner on the Media Partner website.

Insertion of the WCS event in the event calendar, both printed and/or online.

Announcement article of the conference on the Magazine and/or Website.

Dedicated email blast to all subscribers

Sponsors

Top Sponsors for WCS - World Compliance Seminars


speaker

If you wish to sponsor our event

Please contact us: 

partner@worldcomplianceseminars.com or speak with one of the account manager + 844 267-7299


speaker

$2,000 - Silver Sponsor Package Includes

Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases 

Listing in monthly Community Leader newsletter sent to over 50,000 users. 

1 Free Pass for the 2 Day Workshop

Sponsors materials will be distributed onsite to all the attendees


speaker

$4,000 - Silver Gold Package Includes

Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases 

Listing in monthly Community Leader newsletter sent to over 50,000 users. 

2 Free Pass for the 2 Day Workshop

Sponsors materials will be distributed onsite to all the attendees

15-20 minutes product demo during the live session

Windy, Chicago

One of the more breathtaking scenes on the lake is this tall ship approaching the docks at Navy Pier. The 148-foot four-masted schooner (and its new sister ship, the Windy II ) s

Adler Planetarium and Astronomy Museum, Chicago

The building may be historic (it was the first planetarium in the Western Hemisphere), but some of the attractions here will captivate the most jaded video-game addict.

Your first stop shou

Arlington International Racecourse, Chicago

With its gleaming-white, palatial, six-story grandstand and lush gardens, this racecourse is one of the most beautiful showcases for thoroughbred horse racing in the world. Its storied history stre

Art Institute of Chicago, Chicago

You can't -- and shouldn't -- miss the Art Institute. (You really have no excuse, since it's conveniently located right on Michigan Ave. in the heart of downtown.) No matter what medium

Auditorium Building and Theatre, Chicago

A truly grand theater with historic-landmark status, the Auditorium gives visitors a taste of late-19th-century Chicago opulence. Because it's still a working theater -- not a museum -- it'

Back to Top