The Ministry of Consumer Affairs, Food and Public Distribution (Department of Consumer Affairs), after consulting The Bureau of Indian Standards (Govt. of India), has made BIS certification mandatory for Medical Equipment (Clinical Thermometers, Solid stem type & Enclosed scale type) as per specified Indian Standard. BIS Certification ensures national standards for both consumers and manufacturers. This certification also establishes consumer trust, as it guarantees the product meets stringent quality standards.
The BIS certification plays a vital role in ensuring the safety, reliability, and quality of medical devices in India. Among such devices, clinical thermometers, which include both solid stem type and enclosed scale type, are essential diagnostic tools used to monitor body temperature in healthcare settings. BIS certification confirms that these thermometers meet the required Indian Standards (IS) and are safe for public use.
Quality Control Order for Medical Equipment (Clinical Thermometers, including both Solid Stem Type & Enclosed Scale Type)
To enhance public health safety and regulate the quality of critical medical devices, the Government of India issues Quality Control Orders (QCOs) mandating BIS certification for selected products. Clinical thermometers, given their role in health monitoring, fall under this mandate. As per the QCO, no manufacturer or importer is allowed to sell these thermometers in the Indian market without a valid BIS license. This ensures only standardized and safe thermometers reach consumers and medical practitioners.
Manufacturers of clinical thermometers must obtain an ISI mark license from BIS, which certifies compliance with Indian Standards. For solid stem type and enclosed scale type clinical thermometers, the relevant standard is IS 3055, which outlines specifications related to accuracy, safety, and construction. The ISI mark on these thermometers indicates that the product has undergone rigorous testing and meets the established norms for performance and quality.
Ministry of Consumer Affairs, Food and Public Distribution (Department of Consumer Affairs) has issued Quality Control Orders (QCO) on the date, the 9th November,2001 after consulting the Bureau of Indian Standards to regulate the quality of Medical Equipment (Clinical Thermometers Solid stem type & Enclosed scale type) for their production, import, and sale.
(1) This order may be called the Clinical thermometers (Quality Control), Order 2001.
(2) It shall come into force after a period of 6 months days from the date of publication in the Official Gazette.
For more information download :QCO for Medical equipment.
Enforcement Authority – The Bureau of Indian Standards.
Penalty for Contravention:
Any person who contravenes the provisions of clause 3 of this order shall be liable for punishment under Section 33 of Bureau of Indian Standards Act, 1986 and the property in respect of which the order has been contravened, shall be liable to forfeiture.
Why BIS Certification is Important for Medical Equipment (Clinical Thermometers, including both Solid Stem Type & Enclosed Scale Type)
- Patient Safety: Ensures the thermometer provides accurate temperature readings, minimizing the risk of misdiagnosis.
- Quality Assurance: Verifies that the product adheres to specific Indian Standards for material and performance.
- Regulatory Compliance: Enables legal manufacturing and selling under Indian law as per QCO regulations.
- Market Trust: The ISI mark builds consumer confidence in the product’s authenticity and safety.
- Competitive Advantage: BIS-certified products are more likely to be preferred in both domestic and international markets.
Conclusion
BIS certification for medical equipment like clinical thermometers, including solid stem and enclosed scale types, is a critical step in ensuring product quality, safety, regulatory compliance and market credibility. It protects end-users, ensures regulatory compliance, and enhances product credibility in the market. Manufacturers must adhere to the certification process diligently to maintain product integrity and contribute to a safer healthcare ecosystem.
If you are looking for BIS certification or for any further information for Medical Equipment (Clinical Thermometers Solid stem type & Enclosed scale type) feel free to contact us at +91-7503304082 or email at [email protected] for a free BIS consultancy or visit us at www.induceindia.com
