Industry
BIS License (Foreign Manufacturer)
Get professional support for obtaining a BIS license (Foreign Manufacturers Certification Scheme) for Medical Devices, IVDs, Spare Parts, Components & Accessories.
Overview
BIS License under Foreign Manufacturer Certification Scheme (FMCS) is granted to the foreign manufacturer of medical devices and IVDs. The license permits foreign manufacturers to affix Indian Standard Mark (ISI mark) to the medical devices and IVDs without which medical devices and IVDs cannot be imported into India. Those medical devices which mandatorily require ISI mark in order to be imported into India are listed under Quality Control Orders (QCOs). The BIS License is issued in Form VIII by the Foreign Manufacturers Certification Department (FMCD) located at BIS Headquarters, New Delhi.
Services
We provide end-to-end services for obtaining a BIS license, which includes:
- Form V application filing
- Application review
- Documents review
- Authorized Indian Representative on record services
- Official queries response
- Post-application support
- Facility audit preparation support
- Marking fee payment support
- Agreement Execution Support
- Performance Bank Guarantee Execution Support
- Indemnity bond execution support
- Indian Standard Mark (IS mark) usage guidance
- Renewal of License
- License scope change support
- Brand name addition
- Brand name deletion
- Appeal against rejection of application
- Counter sample testing support
Process
There are generally ten (10) steps to obtaining a BIS license under FMCS.
- 1
AIR appointment
Appointment of an Indian resident as an Authorized Indian Representative (AIR)
- 2
Fees
Payment of government fees to BIS
- 3
Application
Submission of application in Form V along with supporting documents.
- 4
Query resolution
Response to the queries raised by BIS (if any)
- 5
On-site Inspection
Foreign Manufacturing facility is inspected by the BIS inspector
- 6
Sample testing
Testing of samples at BIS approved labs
- 7
Approval
Approval of license based on inspection report and lab test reports
- 8
Marking fee payment
Foreign manufacturer pays the minimum marking fee to BIS for grant of license
- 9
Grant of license
BIS license is granted in Form VIII
- 10
Execution
Agreement, Performance bank guarantee and Indemnity bond are executed after the grant of license
Timeline
The average time taken by BIS for the grant of license is generally six (6) months from the date of receipt of application and its recording. However, the timeline is suspended if there is a delay in response to queries raised, scheduling of inspection, transportation of samples and remittance of dues etc.
Validity
A license is granted initially for two years, after payment of minimum marking fee. The license may be renewed for up to five years thereafter.
Key documents required
- Application Form V
- Nomination Form for AIR
- Scope of License letter
- Manufacturing license
- Payment Receipt
- Test reports
Fees
1. Application Fee: ₹1,000
2. Renewal Application Fee: ₹1,000
3. Annual Licence Fee: ₹1,000
4. Marking Fee – As applicable
5. License Scope Extension Fee: ₹5,000 per for inclusion of new varieties per variety or, where grouping guidelines are available, per group of varieties.
6. Inspection Fee (other than regular surveillance or complaint-based): ₹7,000 per man day.
7. Testing Charges – As applicable
8. Issue of Duplicate certificate - ₹1,000
9. Testing of Counter Samples - twice the normal testing charges
10. Witnessing of Counter Sample Testing - ₹10,000. Cost of travel, boarding, and lodging of BIS official (if outstation travel is required) extra.