We can provide global in-country representation and regulatory agency submissions through our international offices in India, UAE, Bahrain, Saudi, Oman, Kuwait, Qatar and United Kingdom. We also have 'Channel Partners' in other regions who provide similar services.
We cover all the aspects of Regulatory Registrations related to General Sale, Conventional, Medical devices, Herbal, Supplements, Cosmetics as follows
- Classification
- MAH Registrations Guidance
- Manufacturing Site Registration/Renewals Guidance
- Product Registrations Guidance
- Minor Variations Guidance
- Lab Testing and Analysis Guidance
- Agency Transfers
- Import/Export Approvals
Medical Device Registration :
Certain devices will be regulated at the time of importation even though they don't need to be listed or approved beforehand. To be marketed in the UAE, such products that are exempt from registration or listing must apply for and acquire an import permit.
For other devices, imports won't be cleared unless the DRCD issues a pre-approval for the consignment's importation. To import such devices into the UAE, they must either be listed or registered.
Pharmaceutical product Registration :
The UAE is a significant market for pharmaceutical drugs, with imports outnumbering domestic production. Numerous foreign pharmaceutical companies have reaped the benefits of the lucrative UAE market, highlighting the importance of maintaining strict safety standards for the benefit of consumers. The Ministry of Health and Prevention regulates the import and distribution of pharmaceutical products in the UAE (MOHAP). Importers and manufacturers of pharmaceutical products must therefore register with MOHAP in order to sell their products anywhere in the UAE.
Pharmaceutical Registration Process :
The Ministry of Health's e-services platform must be used to register pharmaceutical products,Medspero will assist you in the registration process.The following are the crucial actions in the procedure:
- Details on the product's shelf life and storage circumstances
- Pay the required fee.
- Three Samples of the product
- Name and address of the company with marketing and manufacturing rights
- A technical committee will evaluate the submission before approving registration.
- If all conditions and prerequisites are met, the ministry gives certificates of registration for products.
The Ministry issues product registration certificates that are valid for five years starting on the date of committee approval. The certificate is valid for a year starting on the date of issuance for pharmaceutical products manufactured locally.
OTC Products Registration :
This includes Dietary Supplements, Medicated Cosmetics, Antiseptic and Disinfectants and Miscellaneous products which contains pharmaceutical ingredients and/or a medical claim and cannot be classified as medicines.
Basic Requirements :
- Application and Document Reception Form for New GSL Product Registration
- Certificates issued by Competent Authorities in Country of Origin.
- Valid company registration certificate.
- The applicant should have a medical store licensed by the Ministry of Health.
Listing of Medical Devices:
In general, Class I devices and products used in hospitals under expert supervision do not go through a thorough review before being required to be listed. The agency will issue a Listing Certificate. After being listed, the devices must obtain an import permission in order to be sold in the UAE.
Manufacturing Site Registration :
For the Ministry of Health and Prevention registered products, the Company and Manufacturing Sites must be registered by the Ministry of Health and Prevention. It takes 4-6 months to register a company and a site. Registration of a company, a site, or a product with the Ministry of Health and Prevention is valid for 5 years, after which it must be renewed.
The application is obtained from the Technical Affairs Section Secretary, the structures are divided into two parts: part 1 (for Marketing Authorization Holder MAH) and part 2 (for manufacturing site); at the end of each structure, there is a list of documents that must be attached alongside the structure; and the applications must be filled and stamped.