SEMINAR ON REGISTRATION OF MEDICAL DEVICE

SEMINAR ON REGISTRATION OF MEDICAL DEVICES

Registration of Medical Device is mandatory base on Medical Device Act 737, 2012. Part II, registration of medical device and conformity assessment body “Requirement for Registration of medical device Part 5 (1) No medical device shall be imported, exported or placed in the market unless the medical device is registered under this Act.”

Overview: Medical device product registration had been a hot topic among the stake holder ever since the Medical Device Act 737, gazetted and its requirement for all medical device related supplier or importer to register. It had been a concern on the safety and performance of medical device being used and already widely circulated in the country. Since no act had governing the supply and activity regarding the medical devices  supply chain, registration of medical device will be a move to ensure all medical device being circulated and distributed in the country  had undergone strict evaluation and monitoring, especially from the regulatory body, MDA.

The Topics: To make awareness of the registration approach Understanding the documentation requirement Compliance with product safety and performance Understanding CAB assessment requirements Consequences of product sold without registration The Fast Tract approach.

Speaker: MDA official (To be advice) CAB representative TBA

Who Should attend: Medical Device LAR Medical device Importer Medical Device distributor Medical Device Manufacturer Target audience: 100 pax

Date and Time: Date: 15/8/2015   Time: 9.30am - 1.00pm Duration: 1/2 day

Location: Ballroom, Hotel,  Shah Alam

Fee: RM 168 per pax. E- mail your enquiry to: sales.ummahsynergy@gmail.com @ booking at 03 7831 8502 (IZA)