Malaysia MDA implement first edition guideline on “How To Submit An Application For Registration Of A Refurbished Medical Device (MDA/GL/10), January 2023″.
This guideline document was prepared by the Medical Device Authority (MDA) to help the industry and stakeholders in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.”
Please refer to the following link for more details: https://portal.mda.gov.my/doclink/final-guideline-refurbishment-050123-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJmaW5hbC1ndWlkZWxpbmUtcmVmdXJiaXNobWVudC0wNTAxMjMtcGRmIiwiaWF0IjoxNjczNDIwODMxLCJleHAiOjE2NzM1MDcyMzF9.dXXxxi6oT1yMgb_1tifXPdl_rQYYcgEKvrYVIZqXk18