" The term medical devices covers a vast range of equipment, from simple tongue depressors to haemodialysis machines. Like medicines and other health technologies, they are essential for patient care – at the bedside, at the rural health clinic or at the large, specialized hospital. " MEDICAL DEVICE REGULATIONS Global overview and guiding principles. WORLD HEALTH ORGANIZATION, GENEVA تغطي الوثيقة الرائعة أعلاه تفاصيل متعددة حول التشريعات والقوانين المتعلقة بالأجهزة الطبية. منها على سبيل المثال: قوانين الأمن والسلامة ، ومراحل تأسيس تشريعات وطنية وعالمية للأجهزة الطبية ، وغيرها من المفاهيم.
اليوم يسعدنا أن نتلقى آرائكم حول التشريعات المتعلقة بالأجهزة الطبية في الكويت ، برجاء كتابة ما يطرأ على خاطركم حول هذا الموضوع دون الحاجة لوجود مصدر موثوق لهذه المعلومات .. لأن المطلوب هو إستقراء هذه التشريعات إن وجدت. برجاء إضافة آرائكم (باختصار) كتعليق على هذا الموضوع.
وشكراً
The above document covers many aspects of medical devices regulations such as; medical device safety regulations, standards, process to implement regulatory services within a government and so on.
Today I; kindly, ask our readers to identify a policy, bill, law to control and regulate the use, import, export, resell of a medical device in Kuwait. Your answer does not have to be referenced to some document. Just put down what you have in mind !
Please do that as a brief comment below.
Thanks
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Further readings
4 comments:
As far as I know, there is no regulations governing this area. There is a radiation protection dept. which controls importing and licensing of equipment which emits radiation (ionzing and non-ionizing).. RPD never published any guidelines.
Food & Drugs department in MOH is some how interfering and; again, no clear guide lines.
Finally, Department pf medical supplies (formerly Biomedical Eng.) asks for FDA and CE approval but I challenge them if they know or if they check that !!
Import/export of class 1&2a medical devices? Documents to be in line? No solid answer from anyone.
Please post link(s) relevant to Kuwait import/export procedures.
Dear Anonymous,
As people mentioned before, Kuwait has no clear written guidlines. The best way is to ask you local business partner to visit MOH for that.
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