Throughout the UAE, the health industry is expanding. Dubai is in the process of developing itself as a global medical tourism centre, and there is a movement to develop healthcare quality throughout the world. The post briefly describes the process of regulatory approval of medical devices in the UAE.
Medical Device Registration in Dubai
Registration guidelines for medical equipment have been provided by the Ministry of health. Requirements for a filing for regulatory approval are described in the Compliance Guidelines. The registry scheme helps prevent the introduction in the local sector of dangerous or defective medical equipment, thus encouraging people to obtain medical tools that will benefit them. In establishing guidelines for licensing medical equipment, the Ministry aims at universal standards.
What is a Medical Device
“Medical device” means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article (a) intended by the manufacturer to be used alone or in combination for human beings for one or more of the specific purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of disease.
Classification of Medical Device
|Class I||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 from the legal manufacturer.||Low|
|Class II||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|
|Class III||They are either partially or totally implantable within the human body, and may modify the biological or chemical composition of body fluids.||High – Moderate|
|Class IV||Require design/clinical trial reviews, product certification and an assessed quality system involving clinical trials. These devices affect the functioning of vital organs and/or life-support systems. Devices are usually invasive, life-sustaining, life-supporting, or is used “in preventing impairment of human health or if the device presents a potential unreasonable risk of illness or injury”.||High|
Required Documents for Medical Device Registration
Following documents are needed for the registration of a medical device in the UAE
- Completed online application form.
- Copy of the valid manufacturer registration certificate.
- Free sale certificate/registration from the competent authorities in the country of origin authenticated by the UAE embassy.
- Copy of the product authorization between the company and the agent.
- Certificate of conformity/quality of marketing permit, such as: EC, 510 (K), PMA as per the classification of medical devices Class I, II, III, IV.
- Post-marketing monitoring requirements.
- Copies of product registration certificates from other countries.
- Product data, including description, composition, types, sizes, models, accessories, uses, side effects, prohibitions, warnings, precautions, instructions for use, packaging pictures, pamphlets and manuals.
- Laboratory requirements and analysis, and pricing of certain medical devices.
10.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).
- Special requirements: Certificate of Conformity for devices manufactured with animal derivatives.
Procedures and Steps to Register a Medical Device
In order to register a medical device in the UAE, steps mentioned below should be followed
- Register in the e-services, create a user name and password (if not already registered) and access the electronic system
- Apply for products’ registration after meeting all required conditions and fees
- The competent technical committee will discuss the registration of the products, submit them to the competent ministerial committee, and send letters with the committee’s decision to the companies concerned
- Applicant must follow up with the Drug Analysis Department in the Pharmaceutical Department
- Applicant must complete and submit the requirements as per the predefined appointment
- Relevant technical and ministerial committees will re-discuss the registration of products previously referred to them when company has completed the requirements
- Certificates of registration of products that have been approved for registration, after meeting all the conditions and requirements, will be issued, and will be valid for five years from the date of review
- Pharmaceutical certificates (for locally made pharmaceutical products) will be valid for one year from the date of issue
If the safety and effectiveness of the medical device is established and the Committee approves the registration, a certificate of registration is granted, and the importation and sale of the registered medical device is permitted. The registration is valid for 5 years, although if there are material changes to the product data submitted in support of the application, then the certification may become invalid. The Ministry’s Drug Control Department (DCD) is also entitled to cancel the registration of a medical device if the registrant so requests, or if circumstances warrant cancelling the registration. As the key purpose of registering medical devices is to ensure safety, the Registration Guidelines provide for post-market obligations with regard to monitoring, and preparing for, safety issues that may arise in the market place. Failure to comply with these obligations is a basis upon which the DCD can cancel the registration of a medical device.
The post-market obligations include the obligation to maintain distribution records (to facilitate traceability), to maintain complaint handling procedures and records, to maintain adverse incident reporting procedures and records, and to have procedures in place that will allow the registrant to promptly and effective execute investigations and recalls in respect of defective or potentially defective medical devices.
It can sometimes be difficult for foreign applicants to meet regulatory requirements for medical devices. One example of the type of problem that might be encountered is where the subject medical device is not something that would require regulatory approval in the country of origin, and thus not something for which country of origin approval documentation can be provided.
PRD is the most famous consultancy firm for product registration in Dubai. We are committed to fulfill all requirements of medical device registration. You can Contact Us via our WhatsApp # 971 54 582 1012 or send email at firstname.lastname@example.org.