Medical Devices are regulated by the Drug Control Department in the UAE whose objective is to ensure its safety, efficacy and quality.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN UAE
All applications are to be made through submitting:
An application form (Annex 4 for your Company and Annex 6 for your product);
Prescribed information in detail;
Evidence supporting the placement of the device (to the Drug Control);
Company registration file; and
Registration files of first device(s). Files for any subsequent products, given that they are manufactured by the same manufacturer, do not have to be accompanied by the company file.
Registration files should include the following:
ALL required documents and studies for products; and
The class of the medical device (class 1 to 4).
PRODUCT REGISTRATION DOSSIERS
Product registration dossiers need to include the following:
List of devices intended to be marketed in UAE (Excel sheet format; soft-copy and hard-copy);
Labelling i.e. representative samples for each product category and the company registration dossier and required certificates for each device are to accompany the labels; and
Artwork for each (soft-copy).
Upon acceptance of the application, the processing of an application involves the evaluation of application, request for additional data/samples and clarification of some issues wherever applicable. Upon receiving queries or requests, the processing shall be halted until a response has been received. Applications are prone to cancelation or rejection should no response be received within six months from the date of the written query notification. A pre-registration GMP inspection or Quality System audit may be conducted for verification of compliance as part of evaluation of the device.
SUBMISSION OF DECLARATION
A declaration by the local authorized representative of the application should be submitted for all applications declaring:
By all possible means available, all submitted documents are insured as accurate reflection of truth;
Complete liability for the product and post market plan as submitted for handling of complaints or recalls; and
Full compliance with the requirements of the Drug control department after product placement.
REGISTRATION/LISTING CERTIFICATE OF THE DEVICE
The applicant will be informed once a device is found to have complied with all the registration requirements and a certificate of registration or listing will be issued. In some cases, the approved artwork and design would be attached to the registration certificates.
VALIDITY OF REGISTRATION/LISTING
The registration or listing will be valid for five years or until suspension or revocation by the authorities or termination of the listing.
The validity of the registration shall be subjected to:
Submission of biannual post-marketing surveillance reports for products defined by the Drug Registration and Control Department (DR & CD) to have high potency or requirement of special attention.
Submission of adverse effects reports associated with device usage (applicable for pharmaceutical products under classes 3 and 4 invasive and implantable medical devices).
Relevant authorities may suspend or revoke the registration of a device, or amend the conditions of its registration by giving reasons in writing. Registrants can give a 30 days’ written notice and reasons to the Registration and Drug Control Department for the termination of the registration of the device.
Objections to any decisions made by the Registration and Drug Control Department in relation to any application for registration/listing of a medical device could be submitted in writing to the Registration and Drug Control Department. After consideration, the department may choose to approve or reject the registration/listing of a device.
APPLICATION FOR VARIATION OF A REGISTERED DEVICE
The department should be informed on any significant change(s) that could reasonably affect safety or effectiveness of the device. Such changes may include any (though not limited to) of the following:
Manufacturing process, facility or equipment;
Manufacturing quality control procedures;
Design of the device; and
Under such circumstances, the approval of the Registration and Drug Control Department must be sought before implementation. Should the manufacturer be unsure of the urgency to report a certain change, it should be communicated in writing to the DR&CD with a detailed report of the expected risk and impact and must follow given instructions regarding the change. However, minor change(s) should be notified immediately to the Registration and Drug Control Department and may be implemented without prior approval. All applications for variation to registered/listed device(s) be written and be accompanied by the variation application fee.