All over the world, health care has always been considered a booming business. UAE is one of the fast-growing economies in the world which means that the lifestyle of most people there is hectic. This is not without any impact on the health of the people. According to the World Health Organization (WHO), on a survey conducted, one-third of the adult population is obese, and one of five people are afflicted with diabetes. That is why the Dubai government made it a priority to provide world-class facilities.
The government aims to attract more medical tourists to come to the UAE. The UAE has a strong network of transportation and a solid supply of logistics. Its location is strategic as it is in the center of a transportation network which enables people to go to other countries. The UAE government also aims to make the country appealing for the setting up of a medical equipment business.
The UAE government is also liberalizing its policies and offering incentives for investors to help in improving the healthcare standards and the entire industry. The total medical expenditure for UAE is expected to rise at 4.6 percent of the country’s GDP by the year 2026. It’s a good time to start a pharmaceutical distribution or importation firm in the UAE.
Requirements for Setting Up a Medical Business in the UAE
The following are the requirements for setting up a medical equipment distribution or importation business within the UAE:
- A highly detailed company profile
- All the medical devices need approval from the UAE Ministry of Health (MOH) Drug Registration and Control Department.
- Product list of those manufactured or assembled on the site.
- Filled out application form, which is signed and stamped by an authorized individual in the company.
- A legal and valid manufacturing license given by the designated authority in the country of origin.
- A notarized and authorized original letter to any local establishment allowing them to submit the registration requirements to the Drug Department & Distribution Rights.
- A valid ISO 13485 certificate from the corresponding authorized agency in the country of origin for every site which is involved in the manufacture of medical equipment. This has to be notarized and legalized.
- The UAE Ministry of Health will provide a registration number with a 5-year validity once all the preceding steps are completed.
How to Register a Medical Equipment Importation Company in the UAE
- No imported medical equipment will be cleared from customs unless a pre-approval is given by the UAE Ministry of Health.
- A medical warehouse license must be obtained from the Ministry of Health.
- The Ministry of Health will also inspect the warehouse before the license is issued.
After inspecting the warehouse and the overall location, the following documents must be provided to the Ministry of Health:
- Proof of the inspection
- A detailed description and other information about the medical and pharmaceutical devices that the company intends to import.
- After reviewing the documents, the authorized agency may accept or reject the proposal.
- Once the file is accepted, the Ministry of Health forwards it to a final committee for deliberation.
- The final committee meets every year for four times for a review of all the proposals. The best among them is given the import license.
- When the application is rejected, reasons will be provided by the Ministry of Health. This will allow the applicant company to make all the needed adjustments and reapply.
Now is a good time to set up medical equipment related business in Dubai. The requirements for this increase regularly; that’s why it’s wise to seek the help of the professionals. Contact HBS Dubai for inquiries and additional information.