CLINICAL THERMOMETERS (QUALITY CONTROL) ORDER, 2001 AND MEDICAL X RAY (QUALITY CONTROL) ORDER, 1994:
On November 9, 2001, and October 10, 1994, the Department of consumer affairs and Atomic Energy regulatory Board notified in letter GSR 843(E) and AERB/443/39 MDX/3509/94 the Clinical Thermometer (Quality Control) Order, 2001 and Medical X Ray (Quality Control) Order, 1994 respectively. This order mandates that specific Medical Equipment must adhere to Indian Standards and bear the Standard Mark under a license from the Bureau of Indian Standards (BIS).
Scope of the QCO
Clinical thermometers and medical X RAY devices listed in below table is prescribed under Clinical Thermometers (Quality Control) Order, 2001 And Medical X Ray (Quality Control) Order, 1994 respectively is now mandated for BIS Scheme – I ISI mark certification.
Indian Standard
IS 3055 (part 1)
Product Name
Clinical thermometers: Part1 Solid stem type
Indian Standard
IS 3055 (part 2)
Product Name
Clinical thermometers: Part 2 Enclosed scale type
Indian Standard
IS 7620
Product Name
Diagnostic Medical X-Ray Equipment
Actors affected due to the QCO
Foreign Manufacturers
Foreign manufacturers can obtain a licence to use the Standard Mark on products that comply with the applicable Indian Standards under the Foreign Manufacturers Certification Scheme (FMCS).
To apply, the manufacturer must appoint an Indian resident as an Authorized Indian Representative (AIR). The application process is online, and the overall timeline for obtaining the licence is typically longer—generally around 6 months or more.
Domestic Manufacturers
Domestic manufacturers can obtain a licence to use the Standard Mark through the BIS Product Certification Scheme for products conforming to relevant Indian Standards.
The application process is conducted online, and the typical timeline for obtaining certification is approximately 2–3 months.
Process to obtain BIS Licence
Key Penalties and Legal Consequences
- Fines:Initial offenses carry a fine of no less than ₹1,00,000, while subsequent offences can lead to fines of ₹5,00,000 but may extend up to ten times the value of goods or articles produced or sold or offered to be sold
- Imprisonment:Up to two years for selling, manufacturing, or importing goods without the mandatory ISI mark.
- Seizure and Action:The BIS can conduct raids, seize products without the mark, and initiate legal action.
- Stop-marking/Sales Ban:Authorities can ban the sale of products, order product recalls, and cancel BIS licenses.
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BIS Compliance in India – Trusted BIS partner
Through REACHLaw India Pvt. Ltd., with offices in New Delhi and Mumbai, we provide comprehensive Bureau of Indian Standards (BIS) support – as an Authorized Indian Representative and full-service regulatory partner.
From licensing and representation to post-certification support, our long-standing presence in India and close engagement with BIS authorities ensure efficient, reliable outcomes for both local and foreign manufacturers.
Partner with REACHLaw India for trusted BIS compliance expertise, regulatory foresight, and seamless market access to India and worldwide.
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