The United Arab Emirates (UAE), a notable member country of the GCC, has a developed healthcare infrastructure. Its commercial demand has been proven and steadily increasing. Medical devices in the UAE are categorized into four risk-based types (Class I, II a, II b, and III) under the jurisdiction of the Drug Control Department of the Ministry of Health (DCD MOH). Centralized government and linguistic challenges are major barriers to device approval in the region, along with language difficulty and lack of effective communication channels with health authorities.
What is a Medical Device?
Ministry of Health and Prevention (MOHAP) classifies a medical device as “an instrument, apparatus, implement, machine, appliance, implant, a reagent for in vitro use, software, material or another similar or related article.” The medical device’s intended use must qualify under several permitted uses that include diagnosing, mitigating or treating illnesses or injuries. It also covers anything examining, reporting, supporting, or replacing life systems or a life-supporting procedure, as well as controlling the origin or sanitizing of these devices. Finally, it covers all devices intended for the in-vitro examination of any body part.
Classification of Medical Device
Classification of Medical Device
|Those needing the lowest level of regulation because of low risk to the patient except sterile products. They are subject to the General Controls requirements. Declaration of conformity is accepted by the legal manufacturer.|
|Invasive in their interaction with the human body, but the methods of invasion are limited to natural body orifices. The category may also include therapeutic devices used in diagnosis or in wound management|
Low – Moderate
|They are either partially or totally implantable within the human body and may modify the biological or chemical composition of body fluids.|
High – Moderate
Medical Device Registration
The UAE medical device registration regulations dictate that the only entities allowed to carry out medical device registration are the manufacturer of the medical device or their local representative. The UAE medical devices Registration Guidelines require a drug warehouse to register with MOHAP and possess a valid license before commencing the process to register their devices for import and trade in the country. As for Marketing Authorisation Holder companies, they must also have the approval of the manufacturer and with MOHAP. The local representatives may only act on the manufacturer’s behalf with prior authorization to market the product in the Emirates.
Before starting any part of this medical device or establishment registration, you must complete registration with MOHAP. After that, as part of the application, it will fall under one of the aforementioned categories. The classification is crucial because that will determine what documents you must present. What are the criteria that MOHAP examines when looking at medical devices to authorize in the UAE? They may consider how invasive it will be to an organism, how long the treatment will last, among other factors. Then, based on the class of the product, the Committee at the Drug Control Department that makes the final decision may request more corroborating details about the medical device’s efficacy.
Documents Required for Registration of Medical Device
Following are the required documents that are to be submitted alongside the application to the committee:
- Valid registration certificate for the factory building the device
- Copy of the product agency agreement that the manufacturer and agent signed
- Valid free sale/registration certificate issued by the pertinent authorities in the country of origin legalized at the Emirati embassy
- Requirements for monitoring after marketing the product
- Quality conformity/marketing authorization certificate depending on whether the device falls under Class I, II, III, or IV
- Copies of the product registration certificate from other countries as applicable
- Product information covering all specifications
- Peer-reviewed literature discussing the efficacy of the equipment and analysis from the laboratory
- Three samples (per device), certificate of analysis (per device), outer and inner packaging, and leaflets.
- Acknowledgment of the company to conform to the specifications of the Medical Devices Manual (EC Declaration of Conformity).
- Safety and efficacy data (for products in Class III and IV).
- Price information, such as the ex-factory price
- Post-market requirements that are giving evidence of established process and systems for distribution records
Medical Device Registration Process
Following is the brief overview of the registration process of a medical device in the UAE:
- Obtain a local representative within the UAE with an approved establishment license to act on your behalf.
- Complete the product and company application forms found on the UAE guidance document.
- Submit accompanying technical documents according to the classification of your device.
- The Ministry of Health (MoH) may accept the accreditation of CAB (conformity assessment bodies) from the EU, Australia, Canada, the US, Japan, and Singapore.
- The application will be processed, and samples/clarification may be required
- If no response to a query/request is received within six months, the application may be canceled
- The registration or listing of a medical device shall be valid for five years
- The manufacturer and/or local rep should provide biannual post-marketing surveillance reports for high-risk devices.
Time Frame and Validity of the License
It takes approximately nine months to receive the approval of the medical device license in the UAE. Licenses issued for the medical devices in the UAE are valid for five years.
What We Can Do
The intricate legal framework proves the value of working with Riz and Mona Consultancy when dealing with medical devices in Dubai or any other part of the UAE. Whether you choose to pursue the Free Zone model at the Dubai Healthcare City Free Zone or anywhere on the mainland, our team is ready to help you be part of the healthcare and pharmaceutical innovations taking place in the UAE. We will also guide on understanding the advantages stemming from this low-tax, flexible business jurisdiction. Schedule your initial consultation to get started today!