Registration

Medical Device Regulation and Registration in Japan

Mar 29, 2012
Lund, Sweden

Introduction

It has been said Japan was the most difficult country in the world when it comes to medical device registrations. Your business partner in Japan often just asks for detailed technical documents without justification why they were needed. This course is designed to give participants a clear introduction on Japan’s regulatory framework and regulations for medical devices. The requirements on the Quality Management System, the application dossier as well as necessary clinical data.

After this course the participants should have gained a good insight of the registration process in Japan and understand the key aspects and steps. Correct business decisions and future registration activities should be easier to conduct. Some important regulations in English will be included in the course material for homework and future references.

Targeted attendees

Whoever works in the business of medical devices and has a need to understand Japan’s regulatory requirements and process, such as,

•  Regulatory professionals
•  R&D engineers
•  Project leaders and managers, risk managers or specialists
•  Professionals in QA and QM
•  Marketing professionals
•  Senior managers
•  CEO

Instructor

Lian Zhang, Ph.D., Sr QA&RA Consultant, Synergus AB, Sweden

Preliminary course program

Time	Contents
09.00—09.30	Registration and coffee
09.30—10.00	Introduction (Speakers, Synergus and the participants)
10.00—12.00	National regulators Regulatory framework and requirements
	Accreditation of foreign manufactures J-QMS requirements
12.00—13.00	Lunch
13.00— 15.00	Preparation of application dossier and registration timeline Requirements for Clinical data
15.00—15.30	Coffee
15.30—16.00	Clinical investigation in Japan
16.00—16.45	A case study
16.45—17.00	Questions and discussion

 

Course date and venue

2012-03-29, 09:00 – 17:00

Betahuset 5, Conference room Black Silk

Ideon Science Park

Scheelevägen 17

223 70 Lund, Sweden

 

Course fee

SEK 5 000 excl. VAT/MOMS (course material, morning coffee, lunch and afternoon coffee are included)

Please indicate special considerations on meals.

Invoice will be sent upon confirmation of registration.

Registration

Click on "registration" above or contact us via

Email: info@synergus.com or Tel: +46 (0)8-544 767 50

Limited number of participants

Please indicate clearly the course name and date

Last registration date: March 22, 2012

( 2 seats available)

 

Cancellation policy

•  before and on the last registration date, 20 % of the fee
•  after the last registration date, full fee

You may replace one participant with another person if you inform us no later than 3 days before the event. Courses may be cancelled by the organizer if bookings fail to reach minimum numbers. In such circumstances full course fees will be refunded.