Industry
BIS Compulsory Registration (CRS - Foreign Manufacturer)
Get professional support for obtaining a BIS Registration under the compulsory registration scheme (CRS) for foreign manufacturers of Medical Devices, IVDs, Spare Parts, Components & Accessories.
Overview
BIS Compulsory Registration is granted to the foreign manufacturer of medical devices and IVDs. This registration permits foreign manufacturers to affix a Standard Mark to the medical devices and IVDs without which medical devices and IVDs cannot be imported in India. Those medical devices which mandatorily require Standard mark in order to be imported into India are listed under Quality Control Orders (QCOs) or Compulsory Registration Orders. This Registration is based on self-declaration of conformity for medical devices and IVDs as per Indian Standards. The BIS Compulsory Registration (CRS) is issued in Form V by BIS.
Services
We provide end-to-end services for obtaining a BIS Compulsory Registration (CRS), which includes:
- Form I application filing
- Application review
- Documents review
- Authorized Indian Representative on record services
- Official queries response
- Post-application support
- Testing samples at BIS Labs
- Processing fee payment support
- Labelling Guidance
- Standard Mark usage guidance
- Renewal of registration
- Registration scope change support
- Brand name addition
- Brand name deletion
- Suspension of License Support
- Post approval change support
- Post approval compliances support
- Representation before BIS
Process
There are generally seven (7) steps to obtaining a BIS Compulsory Registration (CRS)
- 1
Login Credentials
Preliminary Registration on the online portal to generate login credentials
- 2
Application Form Filling
Filling the online generated application form in Form I
- 3
Payment of Fees
Payment of government fees to BIS through the online portal
- 4
Testing in BIS Approved labs
Generation of test requests through the portal and testing of products at BIS Approved labs
- 5
Submission of Documents
Submission of documents along with test reports within 90 days of issuance of test reports
- 6
Review by BIS
BIS to review the documents and test reports
- 7
Registration
Grant of import registration in Form V
Timeline
BIS Compulsory Registration (CRS) for foreign manufacturers is generally granted within 4 to 6 months from the date of submission of complete set of documents and application subject to satisfaction by the reviewing authority. However, timelines may vary due to factors such as delays in responding to queries, pending test reports, or unpaid fees etc.
Validity
BIS Compulsory Registration for foreign manufacturers is granted initially for two years. Registration may be renewed for up to five years from the last date of its validity.
Key documents required
- Application Form I
- Nomination Form for AIR
- Self-Conformity Declaration documents
- Scope of Registration letter
- Manufacturing license
- Test reports
Fees
Application Fee: ₹1,000
Annual License Fee: ₹1,000
Renewal Application Fee: ₹1,000
Processing Fee:
₹50,000 per application for grant of a license
₹50,000 at the time of license renewal
Inclusion of New Varieties or Models / Scope Extension: ₹30,000 per application
Post Approval Changes (changes in name, address, management, contact info, Indian representative, model withdrawal, or update in critical components): ₹5,000 per request
Additional Test Reports: ₹20,000 for each extra test report (if more than one is submitted)