Searchable PDF text layer
All submission of notification of changes shall be accompanied with a fee as per the table below. Payment shall be made by the applicant prior to endorsement/acknowledgement by MDA. Table 1: Change notification fees Category 2 Category 3 Medical Device Risk Class (RM) (RM) Class A 50 Class B 500 Class C 1000 30 Class D 1500 Medical device that contains a 2500 medicinal product Table 2: Example of calculation fees for change notification of single and multiple applications No Application Calculation 1 Single application for one Example: The applicant has submitted a single application category (either Category 2 under Category 2, Class B. or Category 3) 𝐶𝑎𝑙𝑐𝑢𝑙𝑎𝑡𝑖𝑜𝑛 𝑓𝑒𝑒 = 𝑓𝑒𝑒 𝑓𝑜𝑟 𝐶𝑎𝑡𝑒𝑔𝑜𝑟𝑦 2 𝑎𝑛𝑑 𝐶𝑙𝑎𝑠𝑠 𝐵 = 𝑅𝑀 500 2 Single application for Example: The applicant has submitted single application under Category 2 and Category 3 Category 2, Class B and Category 3, Class B 𝐶𝑎𝑙𝑐𝑢𝑙𝑎𝑡𝑖𝑜𝑛 𝑓𝑒𝑒 = 𝑓𝑒𝑒 𝑓𝑜𝑟 𝐶𝑎𝑡𝑒𝑔𝑜𝑟𝑦 2, 𝐶𝑙𝑎𝑠𝑠 𝐵 + 𝑓𝑒𝑒 𝑓𝑜𝑟 𝐶𝑎𝑡𝑒𝑔𝑜𝑟𝑦 3, 𝐶𝑙𝑎𝑠𝑠 𝐵 = 𝑅𝑀 500 + 𝑅𝑀 30 = 𝑅𝑀 530 3 Multiple application for one Example: The applicant has combined 3 submission IDs under category (either Category 2 Category 2, Class B. or Category 3) 𝐶𝑎𝑙𝑐𝑢𝑙𝑎𝑡𝑖𝑜𝑛 𝑓𝑒𝑒 = 𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑠𝑢𝑏𝑚𝑖𝑠𝑠𝑖𝑜𝑛 𝐼𝐷 𝑥 𝑓𝑒𝑒 𝑓𝑜𝑟 𝐶𝑎𝑡𝑒𝑔𝑜𝑟𝑦 2 = 3 𝑥 𝑅𝑀 500 = 𝑅𝑀 1500 4 Multiple application for Example: The applicant has combined 3 submission IDs under Category 2 and Category 3 Category 2, Class B and Category 3, Class B 𝐶𝑎𝑙𝑐𝑢𝑙𝑎𝑡𝑖𝑜𝑛 𝑓𝑒𝑒 =(𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑠𝑢𝑏𝑚𝑖𝑠𝑠𝑖𝑜𝑛 𝐼𝐷 𝑥 𝑓𝑒𝑒 𝑓𝑜𝑟 𝐶𝑎𝑡𝑒𝑔𝑜𝑟𝑦 2) + (𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑠𝑢𝑏𝑚𝑖𝑠𝑠𝑖𝑜𝑛 𝐼𝐷 𝑥 𝑓𝑒𝑒 𝑓𝑜𝑟 𝐶𝑎𝑡𝑒𝑔𝑜𝑟𝑦 3) = (3 𝑥 𝑅𝑀 500) + (3 𝑥 𝑅𝑀 30) = 𝑅𝑀 1500 + 𝑅𝑀 90 = 𝑅𝑀1590