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Medical Device Conformity Assessment
Conformity assessment is a systematic and ongoing examination of evidence and procedures to ensure the safety, performance, benefit and risk of medical devices. Following Circular Letter of The Medical Device Authority No. 2 Year 2014 Conformity Assessment Procedures for Medical Device Approved by Recognised Countries, all medical devices that have been subjected to conformity assessment and approved by any of the recognised foreign regulatory authorities or notified bodies with respective approval type, as specified in this Circular Letter, may subjected to verification process, which is a simpler conformity assessment process through process of verification of evidence-based compliance.
Conformity assessment is a systematic and ongoing examination of evidence and procedures to ensure the safety, performance, benefit and risk of medical devices. It is also to ensure manufacturing compliance to essential principles of safety and performance (EPSP) and requirements of the Medical Device Act 2012 (Act 737). The classification of a medical device determines the conformity assessment procedures to be undertaken. Conformity assessment becomes more stringent as the risk of medical device increases.
Conformity assessment is a systematic and ongoing examination of evidence and procedures to ensure the safety, performance, benefit and risk of medical devices. Any medical device which already being registered with Medical Device Authority require to assess their product via Conformity Assessment for the purpose of Re-registration prior to its expiry date. The process of assessment follows requirement imposed in MDA/GL/08 Guideline for Re-registration of Registered Medical Device.