Definition of Digital thermometers
Digital thermometers are temperature-sensing instruments that are easily portable, have permanent probes, and a convenient digital display. The way a digital thermometer works depends upon its type of sensor. Sensor types include resistance temperature detector (RTD), thermocouple and thermistor.
Digital Thermometer comes under the category of measuring instruments so, as per the Legal metrology act 2009, all weights and measures should be registered under the ministry of consumer protection and weight and measurement.
Registration under Medical Device Rules 2017, CDSCO
Digital Thermometers need mandatory registration with effect from 1st Jan 2021.
Based on the proposal initiated by the Ministry of consumer affairs, food and public distribution, to the central licensing authority, Central Drugs Standard Control Organization (CDSCO), to include many devices under the ambit of the DCGI, Digital thermometers finally need mandatory registration under the Medical Device Rules 2017 as well as other standards set by the Bureau of Indian Standard (BIS) certification from time to time.
As per, Notification number 648(E) .Under the Medical Device Rules 2017, It was clarified that the following types of devices will be considered as drugs from 1st April 2020.
“All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
(iii) investigation, replacement or modification or support of the anatomy or of a physiological process;
(iv) supporting or sustaining life;
(v) disinfection of medical devices; and
(vi) control of conception.
As notified, Digital thermometer is a device used to record the body temperature.Registration for Digital Thermometer under the above rules is mandatory with effect from 1st Jan 2021 under Class B of Medical Device Rules 2017. Read more
Registration under Legal Metrology (Model Approval) Rules 2011
As per THE LEGAL METROLOGY (MODEL APPROVAL) RULES 2011, Registration of Importer, repairer or Manufacturer is mandatory under the Model approval Rule 2011 With Legal Metrology wing under Ministry of Consumer affairs.
PROCESS
- Sharing Preliminary Information with NKG experts
The Importer / Manufacturer/Repairer of any Weight and Measures will share details of such products with NKG. - NKG experts to share regulatory documents
If the product comes under the scope of Legal Metrology (Model aprroval) 2011 and ETA approval, NKG team will share necessary checklist of documents with the client. - Application submission by NKG experts
After receiving executed documents, NKG will apply online / offline to the Central Legal Metrology Department and online in DOT. - Assigning of an officer in Headquarters
After receiving the application, the Central Legal Metrology Department will assign an officer to the case. - Testing by NABL lab
After receiving the sample, the lab test and verdict on the sample either pass or fail, if the sample will pass then process further. - Application processing in Headquarter
The officer will securitize all submitted documents. If the processing officer is not satisfied and needs further clarification, then he/she may ask further questions. - Grant of Approval
If the processing officer is satisfied with the answers, then he/she may grant the Certificate of Registration under A under the Legal Metrology (Model approval) Rules 2011
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