Interim Regulations Implementing Rule
Please Click in the Below Headings to access the relevant SFDA Documents :
- 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.
- 2Implementing Rule on Establishment Registration – MDS – IR2
This document specifies and refines the provisions of CHAPTERS THREE and FOUR of the Medical Device Interim Regulation. Local manufactures, authorized representatives, importers and distributers involved in the supply of SFDA authorized medical devices shall register their establishments with the SFDA’s Medical Device National Registry (MDNR). They shall submit the information specified in Article Eight of Implementing Rule MDS–IR2 before they place such medical devices on the KSA market. SFDA will assign an establishment National Registry Number to each registrant.
- 3Implementing Rule on Medical Devices Listing – MDS – IR3
- 4Implementing Rule on Establishment Licensing – MDS – IR4
- 5Implementing Rule On Licensing Of Authorised Representatives – MDS – IR5
- 6Implementing Rule On The Validation Of Documents – MDS – IR 6
- 7Implementing Rule On Post- Marketing Surveillance – MDS – IR 7
- 8Implementing Rule on Safeguard Procedures – MDS-IR8