Key highlights
Yes. Under the Diagnostic Medical X- Ray Equipment, BIS certification (ISI Mark under Scheme-I) is mandatory for manufacturers and importers of products covered under the order. Commercial production or import without a valid BIS license is prohibited under the BIS Act, 2016.
- Governed under BIS Scheme-I (ISI Mark Certification).
- Certification status: Mandatory for all manufacturers and importers.
- Official Gazette Notification: https://www.bis.gov.in/MandatoryProducts/QCOrder/Medical%20X%20Ray%20QC%20order.pdf.
Key details
- Order number
- QCO Notification
- Notified
- Implementation date
- As per Gazette notification
- Status
- In force
- BIS certification
- Mandatory
- Licence needed
- BIS licence (ISI mark)
- Scheme
- Scheme-I: Product Certification (ISI mark)
- Products covered
- 1
- Penalty
- Up to ₹5 Lakh
- Last verified
- October 2026
Products Covered (1)
Each product below needs BIS certification under this order. Open one for its standard and process.
Dates and Amendments
Notified in the Gazette
1 January 2024
Fully implemented and enforceable across India for all domestic manufacturers, foreign manufacturers, and importers.
Who Must Comply
- Indian manufacturers
- Importers
- Foreign manufacturers
- Traders, sellers and distributors
How to Comply
Covered products are certified under the Product Certification Scheme (Scheme-I, ISI mark). These are the standard steps.
- 1
Confirm the standard and product scope
Check the Indian Standard that applies, the product variants and grades you make, and whether a Quality Control Order makes certification mandatory.
- 2
Apply on BIS Manakonline
Submit the licence application with factory, manufacturing and quality-control details and pay the application fee. Foreign manufacturers apply under the Foreign Manufacturers Certification Scheme (FMCS) and appoint an Authorised Indian Representative.
- 3
Factory inspection and sample testing
A BIS officer inspects the factory, checks the manufacturing and in-house testing set-up, and draws samples for testing against the Indian Standard in a BIS or BIS-recognised laboratory.
- 4
Licence grant
Once the samples pass and the inspection is satisfactory, BIS grants the licence, and the product can carry the ISI mark with the licence number.
- 5
Surveillance and renewal
BIS keeps checking marked products through surveillance inspections and market samples, and the licence must be renewed before it expires.
Penalty for Non-Compliance
Up to ₹5 Lakh
Violations of mandatory Quality Control Orders are punishable under Section 29 of the BIS Act, 2016 with imprisonment up to two years, fines up to ₹5,00,000 (or up to 10 times the value of goods), and confiscation of non-compliant inventory.
Official Sources
Compiled from the Gazette of India and official BIS sources, last verified in October 2026. Orders are amended and deferred from time to time; confirm the current position with BIS or the issuing ministry before acting on it.
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