****NEW FOR 2020 **** ASEAN MEDICAL DEVICE REGULATORY SEMINAR & WORKSHOPS (SAFETY/PERFORMANCE AND QMS RELATED)

01/01/20 - 31/12/20

ASEAN MEDICAL DEVICE REGULATORY UPDATE – SEMINAR TO BE CONDUCTED IN SINGAPORE IN 1ST HALF 2020

We will organise a seminar to cover ASEAN Medical Device Regulatory Update in 2020.   The venue will be in Singapore.  Please contact Andrew Ho, Biz Development Director of DH RegSys at email : aho@dhregsys.com for details of the 1 day seminar.   We will bring local regulatory experts from the major ASEAN countries (Indonesia, Thailand, Philippines and Vietnam) to give an update of the current regulatory requirements for registration of medical devices.  Our partner from Taiwan will also cover Taiwan medical device regulatory process.  We will also address the related issues like Local authorised representation (otherwise known as License holder);  labelling; local language requirements where relevant; current status/progress of adoption of AMDD and other related and relevant matters.  During the seminar, the participants will also be able to interact with our local Consultants to understand other matters like importation process;  finding importers/distributors; etc.   Please note that our local regulatory partners are have established local legal entities in the respective countries.

MEDICAL DEVICE SAFETY AND PERFORMANCE RELATED WORKSHOPS TO BE CONDUCTED IN SINGAPORE DURING 1ST HALF 2020 

  • CLINICAL EVALUATION – 2 DAY WORKSHOP
  • MEDICAL DEVICE  TECHNICAL FILE – 2 DAY WORKSHOP
  • DESIGN CONTROL – 2 DAY WORKSHOP
  • RISK MANAGEMENT  – 2 DAY WORKSHOP

All workshops to be conducted by our Principal and Senior Consultants.   Our Principal Consultant has over 30 years of medical device with QA/RA background and in manufacturing environment. 

For more details, contact Andrew Ho, Biz Development Director of DH RegSys at email : aho@dhregsys.com for details of the above workshops.

 



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