BIS Scheme II of Schedule II
CRS is not the ISI mark, and the difference decides who carries the risk
The Compulsory Registration Scheme operates under the Electronics and Information Technology Goods (Requirements for Compulsory Registration) Order, 2021, notified as S.O. 1248(E) on 18 March 2021 under Section 16 read with Section 25(3) of the BIS Act, 2016. BIS operates it under Scheme II of Schedule II of the BIS (Conformity Assessment) Regulations, 2018.
It looks like the ISI scheme from the outside. It behaves very differently. Medfins International determines whether your product or its components are caught, manages the testing and registration, and acts as Authorised Indian Representative for overseas manufacturers.
CRS against ISI, in one table
| Scheme I, ISI mark | Scheme II, CRS | |
|---|---|---|
| Basis of grant | Assessment of manufacturing and testing capability plus product testing | Self-declaration of conformity supported by a test report |
| Who holds it | Manufacturer, for a factory, product and standard | Manufacturer, linked to factory, product and brand |
| Testing | BIS-arranged testing and surveillance samples | BIS-recognised laboratory only, report not older than ninety days |
| Mark | Standard Mark with licence number | Standard Mark with unique R-number |
| Validity | Initial grant one to two years, renewal up to five | Two years, renewal from two up to five years |
Importers and traders cannot hold a CRS registration. BIS is explicit that it is the responsibility of the manufacturer or its authorised Indian representative to get products registered.
Are medical devices covered?
No medical, laboratory, diagnostic or electro-medical product currently appears on the notified list of goods under the Order. That is a useful answer, but it is not the same as an exemption, and three things still catch medical and laboratory businesses:
- Components. Notified goods such as standalone switch mode power supplies, power adaptors for IT equipment, sealed secondary cells and batteries, automatic data processing machines and visual display units are covered in their own right. An instrument shipped with a separately imported power supply can pull the obligation in through the accessory.
- The Highly Specialised Equipment route. Paragraph 8 of the Order exempts equipment manufactured or imported at fewer than 100 units per model per year that meets criteria such as three-phase power supply, current rating above 16 amperes, dimensions exceeding 1.5 m by 0.8 m, or weight above 80 kg. The amended criteria take effect from 15 June 2026. Applications are filed on ICEGATE and MeitY issues the exemption within five working days.
- The unit cap. HSE exemption letters are valid to the year end, and once the 100-unit threshold is reached, further imports require BIS registration. Firms that grow past the cap mid-year are exposed.
The Authorised Indian Representative
A foreign manufacturer must either set up a liaison or branch office in India, or nominate the Indian brand owner, or where no brand owner exists in India, nominate another Indian entity as its authorised representative. The AIR undertakes responsibility for compliance with the BIS Act and the rules and regulations made under it, is liable to meet all outstanding financial dues to BIS arising at any stage in connection with the registrations, and accepts full liability in the event of a violation.
That is a real liability, not a postal address. It should be placed with an entity that understands what it is accepting.
Marking
Under the BIS marking circular of 6 September 2019, the Standard Mark must appear on the product or the package or both, must carry the licence number and reference to the Indian Standard visibly, must be legible, indelible and non-removable, and must reference the Bureau’s website so consumers can verify authenticity. The display of the IS number, registration number and words must not be smaller than Arial font size 6. Devices with an integrated display may present the mark electronically.
Where this goes wrong
- Concluding that medical devices are exempt. They are absent from the notified list. No instrument says they are excluded, and the list changes.
- Overlooking the accessory. The adaptor, the battery pack or the display shipped alongside the instrument may be a notified good.
- Letting the test report go stale. A report older than ninety days at the date BIS receives the application will not support the registration.
- Appointing an AIR casually. The AIR carries financial and legal liability for the registration and receives all BIS and MeitY communications.
- Forgetting renewal. Registration runs two years. Renewal should be filed well ahead; a late application attracts a five thousand rupee late fee within ninety days of expiry.
Frequently asked questions
Can our Indian distributor hold the CRS registration?
No. The registration is granted to the manufacturer. A distributor can be nominated as Authorised Indian Representative, which is a different role carrying the liabilities described above.
What does it cost?
Under the fee structure in force from 4 June 2018, the application fee is Rs 1,000, the annual licence fee Rs 1,000, and the application processing fee Rs 50,000 inclusive of one test report, with Rs 20,000 for each additional report. Laboratory charges are separate and set by the laboratory. Concessions apply to micro, small and medium enterprises.
How long does registration take?
BIS states that grant is expected within twenty working days provided documentation and conformity are satisfactory at first instance. Testing time depends on the chosen laboratory.
What happens if we sell without registration?
Section 29(3) of the BIS Act, 2016 provides for imprisonment up to two years or a fine not less than two lakh rupees for a first contravention, not less than five lakh rupees for subsequent contraventions, extending up to ten times the value of the goods. The offence is cognizable.
Do we need both CRS and an ISI licence?
They apply to different products under different schemes. See our page on the BIS licence and ISI mark for Scheme I certification.