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India: Legal Compliances for Infrared Thermometers

June 23, 2020

By Reetika Wadhwa and Nishtha Das

The sudden outbreak of the COVID 19 pandemic has surely left the entire global population baffled and anxious. As the primary symptoms of COVID 19 include flu like conditions, it becomes important to take down the temperature of the symptomatic as well as asymptomatic persons. Owing to these circumstances, the consumption of infrared thermometers has radically enhanced. These thermometers are now required for screening by almost all kinds of establishments, at airports, hotels, restaurant, offices and at all those places which are hosting even a small gathering of people. Therefore, the business of infrared thermometers or digital thermometers is one of the few businesses to have thrived during this crucial situation.

Also read- Sanitizer business and its regulatory framework amidst COVID-19

How do infrared thermometers work: The thermometer is pointed at the forehead of a person without any physical contact and accordingly the person’s temperature is displayed on the thermometer’s screen. An illustrative image of infrared thermometer is pasted below for ready reference

Source: Google Images

Compliances under Legal Metrology Laws

  1. Model Approval – As thermometers are a measuring instrument they require a model approval from the Legal Metrology Department. Any person who wishes to manufacture these thermometers has to obtain the said model approval prior to its manufacturing and import. The application for model approval can be made to the Director of the Legal Metrology Department. The applicant has to submit the sample of the thermometer along with the prescribed fees and documents. The sample thermometer is then forwarded to the standard laboratory which tests the sample and accordingly provides the report as to whether the thermometer complies with the applicable standards. Once the model approval is obtained the, applicant shall be provided with a unique model number which is required to be displayed on all the devices offered for sale thereafter.[2]
  2. Manufacturer and Packer registration – Under the Legal Metrology Act, 2009 and Legal Metrology (Packaged Commodities) Rules, 2011 the manufacturer and packer of the product are required to obtain registration. It is pertinent to mention that the said registrations are mandatory and not optional.[3] If the said registrations are not obtained by the manufacturer and the packer then the same can amount to a non-compliance and the said non-compliance can attract monetary under Rule 32 of the Legal Metrology (Packaged Commodities) Rules, 2011.
  3. Importer’s registration – For those entities which are not manufacturing the thermometers but intend to sell them in the Indian market through an importer are required to obtain importer’s registration under the Legal Metrology Laws. Notably, this importer’s registration is to be obtained apart from the IEC (Importer Exporter Code) which is issued by the Director General of Foreign Trade.
  4. Dealership License – Under the provisions of Legal Metrology Act, 2009 a dealer is required to obtain a dealership license, who is engaged in the business of buying, selling or distributing any weight or measure.
  5. Mandatory Declarations – Under the Legal Metrology (Packaged Commodities) Rules, 2011 any pre-packaged commodity is required to display mandatory declarations on its packaging. Some of these declarations include generic name of the product, name and registered address of the manufacturer and packer, date of manufacture, etc.
  6. Stamping requirements – The Legal Metrology Laws also make it mandatory for weights and measures devices to be duly verified and stamped. The said stamping and verification provide the authorization that the product meets the standard quality as prescribed under the Legal Metrology Laws.

Compliance under Drugs and Cosmetic Laws

As digital thermometers have been classified as a medical device, the manufacturer/ importer of such device is required to register the device with the Central Drugs Standard Control Organisation (CDSCO). The applicant is required to submit the device with CDSCO along with the prescribed fees and documents. Once the registration has been done, a registration number shall be allotted to the device which has to be mentioned on the device’s label.

The compliance process can appear to be an exhaustive process, however, having the required documents in place and designing of the thermometer in accordance with the applicable standards can help in procuring the license in a convenient manner.

[1] Google Images

[2] Rule 5 of the Legal Metrology (Approval of Models) Rules, 2011

[3] Rule 27 of Legal Metrology (Packaged Commodities) Rules, 2011

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