Industry
BIS License (Domestic Manufacturer)
Get professional support for obtaining a BIS license (Domestic manufacturer) for Medical Devices, IVDs, Spare Parts, Components & Accessories.
Overview
BIS License under the Conformity Assessment Scheme-I is granted to the domestic manufacturer of medical devices and IVDs. The license permits domestic manufacturers to affix Indian Standard Mark (ISI mark) without which, medical devices and IVDs cannot be manufactured for sale in India. Those medical devices and IVDs which mandatorily require ISI mark in order to manufacture in India are covered by various Quality Control Orders (QCOs). The BIS License for domestic manufacturers is issued in Form VIII by BIS.
Services
We provide end-to-end services for obtaining an import license, which includes:
- Form V application filing
- Application review
- Documents review
- Official queries response
- Post-application support
- Facility audit preparation support
- Marking fee payment 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 eight steps to obtaining a BIS license by domestic manufacturers.
- 1
Fees
Payment of government fees to BIS
- 2
Application
Submission of application in Form V along with supporting documents.
- 3
Query resolution
Response to the queries raised BIS (if any)
- 4
On-site Inspection
Domestic Manufacturing facility is inspected by the BIS inspector
- 5
Sample testing
Testing of samples at BIS approved labs
- 6
Approval
Approval of license on basis of inspection report and lab test reports
- 7
Minimum marking fee
Domestic Manufacturer pays the minimum marking fee to BIS for grant of license
- 8
License
Grant of import license in Form VIII
Timeline
The grant of BIS license for domestic manufacturers typically takes six months from the date of receipt of complete application and its recording. The timeline may vary for reasons like delays in response to queries raised, if any, organizing inspections, sample deposition, and fee dues, etc.
Validity
A license is granted initially for two years, after payment of minimum marking fee. The license may be renewed up to five years thereafter.
Key documents required
- Application Form V
- Scope of License letter
- Manufacturing license
- Payment Receipt
- Test reports
Fees
· Application Fee: ₹1,000
· Renewal Application Fee: ₹1,000
· Annual Licence Fee: ₹1,000
· Marking Fee – As applicable
· License Scope Extension Fee: ₹5,000 per for Inclusion of new varieties per variety or, where grouping guidelines are available, per group of varieties.
· Inspection Fee (other than regular surveillance or complaint-based): ₹7,000 per man day.
· Testing Charges – As applicable
· Issue of Duplicate certificate - ₹1,000
· Testing of Counter Samples - twice the normal testing charges
· Witnessing of Counter Sample Testing - ₹10,000. Cost of travel, boarding, and lodging of BIS official (if outstation travel is required) extra.