How to Register Medical Devices for Import & Sell in the UAE?
The UAE ranks 14th among the countries that efficiently managed the COVID-19 pandemic. Also, Dubai and Abu Dhabi rank sixth and ninth respectively in the global Medical Tourism Index compiled by International Healthcare Research Centre (IHRC). As these two rankings indicate, importing medical devices for sale in the UAE has turned out to be highly lucrative for investors. However, the importers must conduct medical devices registration in the UAE before importing any such products into the country.
The Ministry of Health and Prevention (MOHAP) regulates and controls the import of medical devices, and hence all such devices should be registered with the Ministry before the sale. Importers and distributors who are fairly new to the healthcare ecosystem in the country can avail the support of product registration agents in Dubai, UAE, to get their products quickly registered. Meanwhile, this blog provides the investors with background knowledge about the steps to be taken for successfully complying with the requirements for medical devices registration in the UAE. Let’s explore.
What Type of Products Qualify for Registration in the UAE?
A medical device can be any medical product containing an element, tool, machine, appliance, implant, in vitro reagent, calibrator or a system that is meant to be applied on humans or animals without any pharmacological, immunological or metabolic effect. The accessories and operating software of such products also come under the definition of medical devices to be registered with the MOHAP. The medical devices are used for purposes including,
- Diagnosis and treatment of any illness, injury or disability
- Prevention, relief monitoring & cure of any disease, injury or disability
- Control of conception
- The investigation, replacement or modification of a physiological process or anatomy
Who is Eligible to Register Medical Devices with the Health Ministry?
As per the MOHAP guidelines, the application for medical device registration in the UAE should be made by the manufacturer, distributor or a local representative of the company. A distributor or a local representative can register the products with MOHAP by securing formal authorisation from the manufacturer. A local representative can be any company offering product registration services in Dubai, UAE.
The product registration consultant will handle the application procedures on behalf of the manufacturer or importer. The authorised distributor or local representative must be available to communicate between the MOHAP and the device manufacturer.
Classification of Medical Devices for Registration
Medical devices are classified into four classes based on the degree of risk associated with their application. The applicants need to understand the four classes while applying for medical device registration in the UAE:
- Class I, low-risk devices
- Class ii, low-moderate risk
- Class iii, high-moderate risk
- Class IV, high risk
Key Requirements for Registering Medical Devices in the UAE
Product registration with the UAE MOHAP requires the manufacturing company or its representatives to submit a list of information and documents. The following documents are required to be submitted for successfully completing medical device product registration in the UAE:
- Product registration application form to be filled, signed and stamped by the company
- Copy of valid registration certificate of the factory
- Certificate of free sale/ registration issued by the competent authorities in the country of origin authenticated by the UAE Embassy
- Copy of authorisation signed between the company and distributor/representative
- Certificate of quality conformity/ marketing authorisation, such as EC, 510 (K), PMA as per the classification of the equipment, i.e. Class I, II, III, IV
- Post-marketing monitoring requirements.
- Copies of product registration certificates in other countries.
- Product’s information, including description, formulation, types, sizes, models, accessories, usages, side effects, contradictions, warnings, precautions, usage guidelines, photos of packaging covers, brochures and user manuals.
- Provide laboratory requirements and analysis, as well as pricing for certain medical equipment
- Providing three samples (as per equipment type), certificate of analysis (as per equipment type), external and internal covers and brochures
- Acknowledgement of the company that equipment conforms to the specifications as per the Medical Equipment Manual (EC-Declaration of Conformity)
- Safety and efficacy data (for products classified as Class III, IV)
- Special requirements: Certificate of conformity to equipment manufactured from animal products
Process of Medical Device Registration in the UAE
In a bid to start the process of product registration with MOHAP, the applicants are required to create an account in the e-services. Those who are not already registered with the e-services must create a username and password to access the system. After creating an account for product registration, the applicants need to make an online product registration request along with the documents and official fee for medical device registration in the UAE. The following process will happen after making the request,
- Discussion by technical committees on the registration of the products and submission of their recommendations to the ministerial committee
- Letters containing the committee’s decision will be sent to the companies concerned
- Applicants at this stage must follow up with the Analysis section at the Drug Department
- Complete and submit the suggested requirements electronically
- The technical and ministerial committees will re-discuss the registration of medical devices that have been deferred in advance when the companies complete the requirements.
- Issuance of product registration certificates for medical devices that have been approved for registration. The certificates are valid for five years effective the date of committee approval
- Issuance of pharmaceutical certificates (for locally manufactured pharmaceutical products) valid for one year effective the date of issuance
Consult with Product Registration Consultants in the UAE
The demand for medical equipment and related accessories witnessed a surge in the aftermath of the COVID-19 pandemic in the UAE. The unforeseen medical emergency in the current situation demands more imports of medical devices into the UAE. However, importers, manufacturers or distributors of medical devices must conduct product registration in the UAE before selling it in the market.
The mandatory requirement of medical device registration in the UAE involves a series of intricate steps that foreign investors may struggle to meet effectively. However, the support of product registration consultants in the UAE, such as Jitendra Intellectual Property (JIP), minimises the struggles of the manufacturers and importers. JIP acts as the local representative of the companies and helps them fulfil all the requirements at minimum costs. JIP has sufficient legal knowledge and industry experience in helping businessmen register their medical devices with MOHAP.