The Medical Device Act A.D. 2008 requires that any person who wishes to manufacture or import medical devices into the Kingdom must obtain a establish licence from the General Secretary of Food and Drug Administration
“Import” means importing or ordering into the Kingdom.
“Manufacture” means make, assemble, invent, repackage separately or collectively, improve, modify or sterilize
Applications and approvals for establishment licences are to be conducted in accordance with the rules, procedure and conditions prescribed in the Ministerial Regulations.
Application documents
- Medical device establishment licence application form
- Photograph of the person who is authorized by the juristic person to do the business (3 photos)
- A copy of commercial registration certificate or incorporation certificate
- Power of attorney for the person who is authorized by the juristic person to do the business
- Power of attorney for the person who is authorized by the juristic person to submit the documents (if any)
- A copy of identity card of powerful person and authorized person
- A copy of household registration of powerful person and authorized person
- In the cause of the powerful person or authorized person are foreigners. the following documents must also be submitted
- – A copy of the passport
- – A copy of the household registration or a certificate of residence in the Kingdom or evidence of permission to enter the Kingdom for temporary stay under the law on migration
- Medical certificate of the person who is authorized by the juristic person to do the business
- Map indicating the location of the place of importer/manufacturer and storage place of medical devices ( 2 copies)
- Planoftheplaceofimporter/manufacturerandstorageplaceofmedicaldevices(2copies)
- Photographoftheplaceofimporter/manufacturerandstorageplaceofmedicaldevices(2copies)