ASEAN Regulatory Requirements - addressing the practical issues workshop

Date: Tuesday 21 May 2024
Time: 8.30am - 12.30pm
Location: Adelaide Convention Centre

Costs: Member: $200 | Non-member: $250

Why understand about medical device regulations in ASEAN region?
The ASEAN region represent an important market for medical device companies due to a variety of reasons including proximity (example being physically closer to Australia than Europe); large market size (population in the region exceeding 600 million) and increasing demand for improvement in standard of health care and therefore demand for medical devices.

ASEAN medical device regulations are guided by the ASEAN Medical Device Directive and this Directive was introduced about a decade ago. In terms of regulatory approvals, ASEAN is different from European EC certification (CE Marking) process. There is no ASEAN version of CE Marking. Medical device companies need to seek regulatory approvals for each ASEAN country. The effort for medical device Regulatory Affairs team is not to be underestimated.

The objectives of this workshop are to:

• Gain an appreciation of ASEAN medical device regulations and the implementation across each country.

• Get an update on current topics of interests on ASEAN medical device regulations.

• Clarify questions you might have in your preparation for registering medical devices in the region. (Please provide your questions in advance via email).

• Appreciation of the requirements for Good Distribution Practice Medical Devices (GDPMD). GDPMD has been and, continued to be, rolled out across the ASEAN countries. GDPMD is a requirement for obtaining Import/wholesale/distribution license.

In addition, there will be a separate but equally important topic on the concepts of Legal Manufacturer and Contract Manufacturer and the requirements for Quality Management System.

Medical devices innovation has been thriving globally and is mainly driven by technological progresses. Research activities are then spin off to a startup company to continue with the development and commercialization of the medical device. With limited financial resources, startup companies typically outsource manufacturing to contract manufacturers.   The relationship between being Legal manufacturer and Contract manufacturer must be managed within a robust Quality Management System (QMS) and the current international standard for Medical Device QMS is ISO13485-2016. The Legal manufacturer and Contract manufacturer business model is not just limited to start ups. Medical device components and finished products can be manufactured in a country (to leverage on economy of scale) and then subsequently shipped to another country (or around the region or the world) as a product made by the Legal manufacturer.

The workshop will be a 1-hour session and the trainer will attempt to provide her experiences of the challenges faced in the real work where spin-off companies try to juggle and manage the relationship with their contract manufacturers. The trainer will give examples of potential pitfalls and lessons learnt.

Speakers

Click on a speaker below to find out more.