On 25 June, 2024 representatives from EuroCham’s Medical Devices and Diagnostics Sector Committee (MDDSC) met with Dr. Nguyen Minh Loi, Director General of the Infrastructure and Medical Device Administration (IMDA), to address pressing issues in medical device licensing.
The meeting, attended by MDDSC Chairman Qadeer Raza, MDDSC Vice-Chairman Fabian Signerl and EuroCham Vice-Chair and MDDSC Vice-Chairman Torben Minko, along with EuroCham’s Head of our Hanoi Office cum External Relations Van Nguyen, focused on accelerating the marketing authorization process for medical devices, a key advocacy point in EuroCham’s Whitebook 2024.
The hour-long meeting covered three main agenda items: the current licensing progress, solutions to ensure continuous supply, and strengthening cooperation under the Memorandum of Understanding (MOU) signed between MDDSC and IMDA in December 2023.
Currently, nearly 8,000 applications for Class C and D medical devices are pending approval, with import licences set to expire on December 31, 2024. The urgency to clear this backlog and ensure a continuous supply of medical devices was heavily emphasised.
Discussions centred around immediate solutions to expedite the licensing process and prevent supply disruptions. Proposals included extending import licences until the end of December 2025 and introducing a grace period for product import licences. These measures are vital to maintaining the availability of essential medical devices in the market.
The meeting also emphasised strengthening cooperation between MDDSC and IMDA, building on the Memorandum of Understanding (MOU) signed in December 2023. The collaborative efforts aim to streamline regulatory processes and enhance the efficiency of medical device approvals.
