Medical Device Regulatory Affairs Training
The medical device and IVD markets in Southeast Asia are growing rapidly, which means there is a need to introduce and update regulatory requirements to ensure the safety and efficacy for end users. Even though the 10 ASEAN member states have adopted the ASEAN Medical Device Directives (AMDD), Southeast Asia remains a collection of different markets, each with their own regulatory processes, which can prove challenging.
Andaman Medical has developed a series of six on-demand medical device regulatory affairs training courses to help you understand the medical device regulatory pathways in Singapore, Malaysia, Indonesia, the Philippines, Thailand and Vietnam. As a result, learners should be able to better navigate the medical device registration processes in each country, avoiding the common pitfalls and so successfully implement their medical device regulatory strategy
Medical device regulatory affairs training courses overview
Our medical device regulatory affairs training courses have been written by our very own Regulatory Affairs Specialists who work in their respective countries registering medical devices & IVDs for manufacturers throughout the world, undertaking renewals, change of ownership/ license transfers and liaising directly with the local regulatory authorities every day. The courses will cover:
- Market Overview
- Authority’s Background
- Legislative Framework
- Registration Information (Classification, Grouping, Process Flow, List of Documents)
- Licenses or Certificates Required
- Registration Fee and Timeline
- Renewal of Medical Devices
- Change Notification
- Change of Ownership/ License Transfer
Who will benefit from the training programs
The medical device regulatory affairs training courses will be of interest to all those who need to learn about successful marketing authorisation processes and in-market regulatory compliance whether as an introduction or a refresher course:
- Regulatory Affairs Specialist
- Regulatory Affairs Manager
- Quality Manager
- Project Manager
- Product Development Manager
- Business Development Manager
Key benefits
The courses are on-demand, which gives full flexibility as to when, where and how learners undertake their training. The courses can be selected according to country of interest or as a complete package, at a fraction of the cost of face-to-face training. Key benefits include:
- A consolidated solution to your medical device regulatory affairs training requirements on one easy-to-use learning platform
- Staff members from multiple departments and site locations locally, nationally, or internationally can take part simultaneously or independently
- Measurable and quantifiable results thanks to the online quiz at the end of the course to test your knowledge
- Practical, interactive, and up-to-date professional development
- A certificate will be awarded upon successful completion of the quiz
- One year’s online access to the course content which can also be downloaded for future reference.
- An online account, listing registration history and payments