The word “Medical device” mainly includes all products used in healthcare for the examination, prevention, observing or treatment of sickness or handicap yet, rejects drugs, and doesn’t gain its principal expected action in or on the human body by pharmacological, immunological or metabolic methods.
Ministry of Health has given registration instructions for medical devices. The Registration instructions set out the necessities for an application for regulatory approval. The registration system is expected to exclude unsafe or ineffective medical devices from entering the local market while permitting patients access to medical devices that may help them.
Medical devices are likewise regulated by the Ministry. As per rules on the Ministry’s site, medical device manufacturers must register with the Ministry before they can market their products in the United Arab Emirates. Companies who want to export their products into the United Arab Emirates must do so through a local representative or distributor who has an authorized medical store.
Medical devices are classified under Class I, Class II a, Class II b, Class III and active implantable devices. The selected local representative or distributor must submit a registration of medical device application form to the Ministry’s Drug Control Department. If the application is accepted, a registration number is provided, which is valid for 5 years.
A registration number can be canceled
- (I) if the candidate demands it or
- (ii) upon failure to fulfill the following standards assessment or monitoring:
- (A) the devices are un-safe as well as harmful;
- (B) the nature of the gadgets is inadequate;
- (C) The devices vary from the approval label.
As indicated by the Ministry, the approval procedure takes between eight to twelve weeks after the application is submitted.
MSZ corporate services provider will assist with all aspects of medical device regulatory approval. Our business consultants will assist to deal with the procedure easy and hassle-free. We would be glad to assist you. For any inquiries regarding registration of medical device get in touch with us, call us +971562181007 or email at email@example.com