MSZ provides expert assistance to individuals and businesses worldwide, helping them establish and expand their operations in the United Arab Emirates and Saudi Arabia. Whether you're launching a new venture or seeking to grow an existing business, MSZ.ae is committed to helping you make informed and strategic decisions for your company's success.
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.
Contact MSZ corporate services provider.
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, Click Here to Contact MSZ or Email to info@msz.ae.
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Why MSZ for your Business?
We help individuals and enterprises from across the world launch and grow their operations in the United Arab Emirates. Whether they are new companies or existing ones. We at MSZ.ae are ready to help you make wiser decisions for your company. Expertise in offering Accounting & BookKeeping Solutions & assistance for establishing a business formation in the UAE, helping customers with their establishment & maintenance needs.
What types of services does MSZ provide?
MSZ specializes in business setup, accounting and bookkeeping, and product registration to support companies in the UAE and Saudi Arabia.
Can MSZ help with registering products in the UAE & Saudi Arabia?
Yes, MSZ offers expert assistance with product registration to ensure compliance with local regulations, making it easier for businesses to launch products in the market.
Does MSZ handle accounting and bookkeeping for businesses?
Absolutely, MSZ provides full accounting and bookkeeping services, helping businesses maintain accurate financial records and meet regulatory standards.