Malaysia’s Medical Device Authority (MDA) has established an Innovative Medical Device Review (IMDR) program to assist developers of novel medical technologies seeking to align with regulatory expectations before formal product registration.
The IMDR program is specifically for innovative medical devices, which are generally defined as devices that incorporate a novel technological concept or significantly enhance the design, effectiveness, or performance of existing devices. During the IMDR process, MDA officers review the documentation available for the device and provide feedback on any gaps that may need to be resolved, particularly related to the Essential Principles of Safety and Performance (EPSP). The initiative also allows the MDA to identify potential gaps in its innovative technologies regulatory framework and take action to close any gaps.
The innovative review is designed to take place before manufacturers engage a Conformity Assessment Body (CAB) and prior to submitting a product registration application to the MDA. By identifying potential compliance issues early, the program aims to reduce the risk of delays during conformity assessment or regulatory evaluation.
Fees for conducting the innovative review depend on the development stage of the device. Reviews for devices in the early development stage cost 1,000 RM ($255) per two-hour session, while pre-commercial stage devices are charged 1,500 RM ($383) per two-hour session. Early development reviews will include recommendations on how to fulfill specific EPSP requirements, while pre-commercial reviews evaluate whether the acquired ESPS data are sufficient and, if not, how to improve them. Applications may be submitted by any Malaysian resident or by a Malaysian authorized representative.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.