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English — NHRA official text (Circular No. (18) 2022, printed alongside the Arabic on the same official PDF)

Circular No. (18) 2022 — Circular No. (18) 2022 — Assigning a post-market surveillance officer

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Chief Executive Office Circular No. (18) 2022 Date: 12 May 2022 To All Health care Facilities Subject: Assinging a Post marker survelince officer Based on Resolution No (48) year 2020, Article No (4) which states that: “The Authority monitors the use of medical devices and products in the Kingdom and takes the necessary and appropriate measures to ensure the safety of their use and maintenance in order to ensure the safety of patients, the public and users of the medical device and product, and the authority shall notify patients or users once it is confirmed that the medical device or product is/are not complying with the of the provisions of this decision.” As a part of NHRA role to ensure the safety of medical devices in post market phase, it strictly recommended from all healthcare facilities and authorized representatives to assign a PMS officer who is responsible for handling medical devices reporting in the post market survalince stage including field safety notices, adverse events and complain reporting to NHRA . Based on that kindly send the details of the nomanaited PMS Officer contact details using the below barcode. Your cooperation is highly appreciated in improving health services in the Kingdom.