Interim Regulations Implementing Rule

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  • 1Implementing Rule on Designation and Oversight of Conformity Assessment Bodies – MDS – IR1 
    This document specifies and refines the provisions of CHAPTER SEVEN of the Medical Devices Interim Regulation. While retaining in full the responsibilities placed upon it by the regulations, the SFDA may designate third-party organizations, known as Conformity Assessment Bodies (CABs), to assist it in carrying out the duties specified in CHAPTERS TWO and SIX of the Medical Device Interim Regulation, and its Implementing Rule MDS-IR6.