Guidance on the Product Grouping for In-Vitro Diagnostic (IVD) Medical Devices. MDA/GD/0054 December 2020 Second Edition Medical Device Authority (MDA) had released a new guidance for upcoming and existing Conformity Assessment Body in their pursuit to comply with the Medical Device Act (Act 737) and the regulations under it. This updated document is written in […]
Medical Device Authority (MDA) had released a new guidance for upcoming and existing Conformity Assessment Body in their pursuit to comply with the Medical Device Act (Act 737) and the regulations under it. This updated document is written in conjunction with the current laws and regulations used in this country which include but not limited […]
(1) All medical device shall be: appropriately classified in accordance with the classification rules as specified in FIRST SCHEDULE; and appropriately grouped using the rules of grouping as specified in SECOND SCHEDULE. (2) In the event of any dispute between the establishment and a conformity assessment body over a classification of a medical device, the […]
