Key highlights
Yes. Diagnostic Medical X-Ray Equipment 9. Diagnostic Medical X- Ray Equipment AERB/443/39 MDX/3509/94,Oct. 94 is on the list of products that need mandatory BIS certification in India under the Product Certification Scheme (Scheme-I, ISI mark). It must conform to IS 7620 (Part 1) and carry the ISI mark (Standard Mark) with the BIS licence number (CM/L-…); without it, the product cannot be manufactured, imported or sold in India. It is covered by the Diagnostic Medical X- Ray Equipment (QCO Notification).
Quality Control Order for Diagnostic Medical X-Ray Equipment 9. Diagnostic Medical X- Ray Equipment AERB/443/39 MDX/3509/94,Oct. 94
The order below makes BIS certification mandatory for Diagnostic Medical X-Ray Equipment 9. Diagnostic Medical X- Ray Equipment AERB/443/39 MDX/3509/94,Oct. 94.
Diagnostic Medical X- Ray Equipment
- Order:
- QCO Notification
- Issued by:
- Department for Promotion of Industry and Internal Trade
- Notified:
- 1 January 2024
How to Get BIS Certification for Diagnostic Medical X-Ray Equipment 9. Diagnostic Medical X- Ray Equipment AERB/443/39 MDX/3509/94,Oct. 94
Diagnostic Medical X-Ray Equipment 9. Diagnostic Medical X- Ray Equipment AERB/443/39 MDX/3509/94,Oct. 94 is certified under the Product Certification Scheme (Scheme-I, ISI mark). Licence applications are processed under the normal procedure (Option 1). These are the standard steps for the scheme.
- 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.
Normal vs Simplified Procedure for Diagnostic Medical X-Ray Equipment 9. Diagnostic Medical X- Ray Equipment AERB/443/39 MDX/3509/94,Oct. 94
BIS processes ISI licence applications under one of two procedures. Diagnostic Medical X-Ray Equipment 9. Diagnostic Medical X- Ray Equipment AERB/443/39 MDX/3509/94,Oct. 94 is not on the BIS Option 2 list, so its licence follows the normal procedure (Option 1).
Normal procedure(Option 1)
Applies to Diagnostic Medical X-Ray Equipment 9. Diagnostic Medical X- Ray Equipment AERB/443/39 MDX/3509/94,Oct. 94You apply first; BIS then inspects the factory and draws samples for testing.
- Timeline
- Depends on the factory inspection and lab testing after you apply
- Who it applies to
- ISI products not on the BIS Option 2 list
- 1
Apply on BIS Manakonline
Submit the licence application with factory, manufacturing and quality-control details and pay the fees.
- 2
Factory inspection
A BIS officer inspects the factory and in-house testing set-up and draws samples.
- 3
Sample testing
The samples are tested against the Indian Standard in a BIS or BIS-recognised laboratory.
- 4
Licence grant
BIS grants the licence once the samples pass and the inspection is satisfactory.
Simplified procedure(Option 2)
You test a sample first and apply with the test report, so BIS can decide faster.
- Timeline
- BIS aims to process the licence within 30 days
- Who it applies to
- Mandatory for products on the BIS Option 2 list (domestic manufacturers, including MSMEs)
- 1
Test a sample first
Get the product tested against the Indian Standard at a BIS or BIS-recognised laboratory.
- 2
Apply with the test report
Submit the application on BIS Manakonline with the test report, factory documents and fees.
- 3
BIS review and factory verification
BIS checks the application and test report and verifies the factory.
- 4
Licence grant
BIS grants the licence, with the aim of doing so within 30 days of the application.
BIS Certification Cost and Timeline for Diagnostic Medical X-Ray Equipment 9. Diagnostic Medical X- Ray Equipment AERB/443/39 MDX/3509/94,Oct. 94
The cost of BIS certification for Diagnostic Medical X-Ray Equipment 9. Diagnostic Medical X- Ray Equipment AERB/443/39 MDX/3509/94,Oct. 94 depends on testing against IS 7620 (Part 1), BIS application and licence fees and the number of models. Timelines depend on lab availability and BIS review.
Get a free estimateCalculate the cost for your case
Government fee, testing, marking fee and timeline for Diagnostic Medical X-Ray Equipment 9. Diagnostic Medical X- Ray Equipment AERB/443/39 MDX/3509/94,Oct. 94, by applicant type, number of models and urgency.
Documents Required
Commonly asked for under this scheme; BIS may ask for more depending on the product.
- Factory registration and address proof
- Manufacturing process flow chart
- List of manufacturing machinery and in-house test equipment
- Quality control plan and test records
- Trademark or brand registration
- Authorised Indian Representative documents (foreign manufacturers)
Testing Labs for IS 7620 (Part 1)
BIS tests samples of Diagnostic Medical X-Ray Equipment 9. Diagnostic Medical X- Ray Equipment AERB/443/39 MDX/3509/94,Oct. 94 against IS 7620 (Part 1) in its own or a BIS-recognised laboratory.
Find BIS-recognised labsOfficial Sources
Compiled from official BIS and Gazette sources and last reviewed in September 2026. Standards and orders are amended from time to time; confirm the current requirement with BIS before you apply.
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