Service Directory
Licence to create a company to import and sell medical devices
Granting licences to companies and manufacturers of medical devices and supplies
Required Attachments
- Provide a new company Commercial Registration
- Application form
- Company procedures
- Storage location information
- The applicant submits the documents required by the NHRA. The documents include submitting an integrated application file (paper or electronic) through the website of the Ministry of Industry, Commerce and Tourism.
Legal Regulations
- Ministerial Resolution No. (48) of 2020 regarding quality control of medical devices and products
Fees
- Licensing application fee: 50 BD (For every new order) : The Authority imposes a delay fine of double the value of the fee due for the renewal of the license in case of delay in payment of the prescribed fee, within three months from the date of its due.
- Medical device company license - Item A: First license 1000 BD (First license)
- Medical device company license - Item A: License renewal 700 BD (annual)
- Medical device company license - Item B: First license 700 BD (First license)
- Medical device company license - Item B: License renewal 500 BD (annual)
- Medical device company license - Item C: First license 500 BD (First license)
- Medical device company license - Item C: License renewal 300 BD (annual)
- Medical device company license - Item D: First license 300 BD (First license)
- Medical device company license - Item D: License renewal 200 BD (annual)
- Medical Devices Warehouse License - First license 1000 BD
- Medical Devices Warehouse License : License renewal 800 BD (annual)
- Medical Devices Factory License: First license 5000 BD
- Medical Devices Factory License: License renewal 3000 BD (annual)
Process Time
- 5 Working Days
Service Provider
National Health Regulatory Authority
Cooperative Entities
- Ministry of Works
- Ministry of Interior - General Directorate of Civil Defense
