Saudi Arabia’s Food and Drug Authority has published its final guidance on the new Medical Device National Registry (MDNR), a streamlined market authorization pathway for low-risk medical devices. This new market route is specifically for Class I non-sterile and non-measuring medical devices and will go into effect this September.
The final guidance does not deviate much from previous versions of the MDNR market pathway; however, it does include additions to and more in-depth explanations of the MDNR flowchart and the declaration of conformity requirements.
The following sections of the MDNR flowchart have been expanded and/or clarified:
- Random Review Process
- While no details have been included about what type of data will be reviewed, this process may focus on the Essential Principles of Safety in Performance described in Annex 3 on page 12.
- Continuation of Medical Device Listing
- This is no renewal process for MDNR listings. Manufacturers must reapply through their local distributors once their three-year listings expire.
- Recall and Withdrawal
- A formal recall process for MDNR-listed devices has not yet been established; however, any future recall process may resemble the MDS-G22.
Finally, device model names/numbers and classification rule numbers must now be included in declarations of conformity for MDNR-eligible devices.