Qualtech Consulting is happy to invite you to our free online Webinar: ASEAN Market Access Strategy & Planning.
The online event is the third of our 2020 series and is scheduled to be held on September 30th (Wed), 2020. Shall this Webinar be of any interest to you or one of your colleagues, please be sure to register using the
Sign Up Link (limited seats available).

Webinar Agenda

  1. Medical Device Registration Requirements in ASEAN
  • The latest requirements for medical device registration in Singapore, Malaysia, Philippines, Vietnam, Indonesia, and Thailand
  • Role and Responsibilities of Authorized Representative (AR) in these countries.

  1. Authorized Representative (AR), Importer, and Distributor’s Responsibilities in ASEAN
  • Comparison of Import conditions and AR responsibilities among ASEAN
  • Good Distribution Practice Strategies of choosing your local representative.

  1. Post Market Surveillance
  • ASEAN Countries Authority Management in PMS
  • The Regulation of PMS in ASEAN

Speaker Introduction

  1. Irene Lu   Manager of Global Regulatory Affair, Qualtech Consulting Co.

Irene has joined Qualtech since 2012, and responsible for the product evaluation, consultancy and clinical trial strategies to ensure each client can enter Asian market at the earliest.

She is specialized in the medical device regulations in ASEAN and clinical trial requirements in China and in Taiwan.

  1. Eve Peng

Eve leads strategic and operational activities in import affairs at Qualtech, focusing on providing a viable and optimal solution for clients and their distributors through Qualtech’s role as an independent representative while engaging in regulatory consulting for device registration, post-market activities and commercial opportunities in ASEAN for Qualtech.

  1. Yee Zi Hui   Regional Leader at Qualtek Consulting Sdn. Bhd in Malaysia.

Zi Hui has been engaged in Malaysia medical device regulations for more than 5 years, and she has experience in Good Distribution Practice (GDP) and product registration.

If you have any questions, feel free to contact us by mail [email protected] or by phone +886-2-2740-1778.

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