SFDA Updates - AHWP

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Medical Devices SectorSFDA UpdatesDecember 2020

Most Recent Regulatory Updates2

1- SFDA Risk Based ClassificationSFDA Has published Guidance (MDS – G42 ) forclassification Rules in accordance to IMDRF andAHWP/GHWP Risk based Classes (A,B,C,and D)MD Classification levelsIVD Classification levelsClass AClass A – supplied sterileClass A – incorporating a measuringfunctionClass A – reusable surgical instrumentsClass BClass CClass DClass AClass BClass CClass D3

2- Medical Device Technical File Assessment Manufacturers of Medical Devices Shall submit the Technical File To SFDA. Approvals from Other Authorities are considered as supporting documents. Technical File Contents are specified clearly in SFDA Guidance (G5)4

3- Quality Management System (ISO13485) Local and Overseas Manufacturers of Medical Devices Shall establish aQuality Management system. SFDA Has adopted the latest version of ISO13485:2016. The Saudi standard is : ( SFDA/GSO.ISO 13485:2017 )5

4- Medical Devices Clinical (Trial ) Investigations Performance Evaluation Studies of In Vitro DiagnosticsMedical Devices (PESIVD) and Clinical Investigations (Trials) of Medical Devices within KSAShall be approved by SFDA before commencement andcomply with ISO 14155:20206

5- SFDA New Guidelines covering advancedtechnology and applications New Guidelines covering advanced technology and applications: Medical devices Cybersecurity (two guidance documents one createdfor healthcare providers and one for manufacturers). Software as a Medical Device 3D printing in medical devices Innovative Medical Devices E-IFU Requirements Artificial intelligence (AI) (draft)7

6- SFDA- Unique Device Identification UDI The manufacturer, or its authorized representative, shall submit andmaintain the appropriate data to UDI database Shall be checked and maintained periodically be manufacturer The data for new UDI-DI shall be available in UDI database at thetime the device is placed on the market. Ensure all data in GHAD System & Saudi-DI are accurate and validsuch as models name, GMDN code , )Go to https://udi.sfda.gov.sa/8

7- SFDA monitors facilities with radiation-emitting devicesto ensure proper complianceSafe use of medical devices9

8- SFDA medical devices efforts during COVID-19 pandemic Creating SFDA special evaluation for Corona Virus (Covid-19) IVD Tests - Emergency Use Authorization (EUA) Acceleration of approval to obtain marketing authorization of any devices needed during pandemic Develop guidance documents for: Protective Medical Goggles and Face Shields – Recognized Standards General Requirements for Medical Devices Manufacturing Requirements for Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories – RecognizedStandards Requirements for Medical Masks and Particulate Respirators – Recognized Standard10

To access these guidelines and more visit the Saudi FDA website via the below linkhttps://www.sfda.gov.sa/en/regulations?tags 311

Contact US12

THANK YOU

SFDA Updates December 2020. 2 Most Recent Regulatory Updates . 3 1- SFDA Risk Based Classification SFDA Has published Guidance (MDS –G42 ) for classification Rules in accordance to IMDRF an

Related Documents:

The principles and rules for classification within the AHWP framework are found in two documents: - For general medical devices -the GHTF SG1/N77:2012 document -"Principles of Medical Device Classification" - For in vitro diagnostics -the AHWP WG2/F001:2016 document -"Principles of In Vitro

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