In the ever-evolving world of healthcare, the innovation and integration of medical devices play a pivotal role in shaping the future of patient care. As manufacturers strive to bring cutting-edge solutions to the market, they find themselves entangled in the intricate web of regulatory frameworks. Among the myriad of guidelines, the juxtaposition of the Saudi Food and Drug Authority (SFDA) medical devices regulations and the European Medical Devices Regulation (MDR) stands out as a compelling narrative of contrasts.
In this labyrinth of compliance, the technical documentation required by SFDA and MDR serves as the compass, guiding manufacturers through the nuanced pathways of regulatory approval. Like two distinct chapters in a global story of healthcare governance, these regulations reflect the unique perspectives and priorities of the regions they represent.
But most of people don’t know that there are significant similarities between both regulations.
SFDA medical devices regulation just copied and pasted MDR technical documentation contents with some slight differences:
Here are the differences between both:
- Essential Requirements Checklist: SFDA ERs checklist and MDR GSPR checklist are almost identical, however SFDA modified some requirements to be appropriate for KSA market (e.g. if the device is intended to be used by lay person so it’s obligatory to provide an Arabic copy of IFU).
- Declaration of Conformity “DOC”: SFDA has a template for DOC which is completely different from DOC template according to MDR “SFDA DOC template is available on their official website”.
- Labelling & IFU: you can use same IFU and labelling data if your device has a CE mark in KSA market except if the device will be used by lay person so in this case, you’ll need to provide an Arabic version of IFU.
- Classification of Products: SFDA has the same classification rules as MDR but the product class is different as in SFDA products are classified as (A, B, C, D) however in MDR they are classified as (I, Iia, IIb & C).
- PMS Plan: SFDA & MDR require the same level of details in PMS plan but the version that will be provided to SFDA should include the methods and protocols of communication with SFDA in case of complaints, safety alerts, etc.).
In the ever-evolving world of healthcare, the innovation and integration of medical devices play a pivotal role in shaping the future of patient care. As manufacturers strive to bring cutting-edge solutions to the market, they find themselves entangled in the intricate web of regulatory frameworks. Among the myriad of guidelines, the juxtaposition of the Saudi Food and Drug Authority (SFDA) medical devices regulations and the European Medical Devices Regulation (MDR) stands out as a compelling narrative of contrasts.
In this labyrinth of compliance, the technical documentation required by SFDA and MDR serves as the compass, guiding manufacturers through the nuanced pathways of regulatory approval. Like two distinct chapters in a global story of healthcare governance, these regulations reflect the unique perspectives and priorities of the regions they represent.
But most of people don’t know that there are significant similarities between both regulations.
SFDA medical devices regulation just copied and pasted MDR technical documentation contents with some slight differences:
Here are the differences between both:
- Essential Requirements Checklist: SFDA ERs checklist and MDR GSPR checklist are almost identical, however SFDA modified some requirements to be appropriate for KSA market (e.g. if the device is intended to be used by lay person so it’s obligatory to provide an Arabic copy of IFU).
- Declaration of Conformity “DOC”: SFDA has a template for DOC which is completely different from DOC template according to MDR “SFDA DOC template is available on their official website”.
- Labelling & IFU: you can use same IFU and labelling data if your device has a CE mark in KSA market except if the device will be used by lay person so in this case, you’ll need to provide an Arabic version of IFU.
- Classification of Products: SFDA has the same classification rules as MDR but the product class is different as in SFDA products are classified as (A, B, C, D) however in MDR they are classified as (I, Iia, IIb & C).
- PMS Plan: SFDA & MDR require the same level of details in PMS plan but the version that will be provided to SFDA should include the methods and protocols of communication with SFDA in case of complaints, safety alerts, etc.).