In November 2018, Malaysia’s Medical Device Authority (MDA) issued the third edition of their Change Notification for Registered Medical Devices. On November 2 this year, the MDA updated this notification. The new updated version includes two main new sections – Clause 5.8 and Clause 8. Changes in section 5.8 refers to changes due to the EU’s recent regulatory transition to MDR and IVDR.
There are 3 types of changes where notification is needed including – 1. changes to labels and IFUs related to materials, 2. changes to IFU related to clarification of existing content and addition of safety information, and 3. changes to IFU (IVD) related to clarification of performance data.
Section 8 outlines new turnaround time for change applications. For single submission ID (category 2 or 3), 30 working days; single submission ID (combination category 2 and 3), 60 working days and multiple submission ID (category 2, 3, or a combination of Category 2 and 3), 60 working days.
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.