Brief Overview of Licenses required for Import, Local Manufacture, and Sale of Infrared Thermometers in India – Medical Devices Regulatory Services

infraredthermometers
Definition of Infrared thermometers

Infrared thermometers are temperature sensing devices that use electromagnetic radiation to make non-contact surface temperature readings. This allows for fast, touchless measurements from a safe distance.

Infrared 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.

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
  1. Sharing Preliminary Information with NKG experts
    The Importer / Manufacturer/Repairer of any Weight and Measures will share details of such products with NKG.
  2. NKG experts to share regulatory documents
    If the product comes under the scope of Legal Metrology (Model approval) 2011, the NKG team will share the necessary checklist of documents with the client.
  3. Application submission by NKG experts
    After receiving executed documents, NKG will apply online/offline to the Central Legal Metrology Department.
  4. Assigning of an officer in Headquarter
    After receiving the application, the Central Legal Metrology Department will assign an officer to the case.
  5. 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.
  6. 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.
  7. 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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