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ISI / BIS Certification for Clinical thermometers Part 2-Enclosed scale type



ISI / BIS Certification is mandatory for

Clinical thermometers Part 2-Enclosed scale type

IS Standard : IS 3055 (Part-2): 2004

Essential medical tools for determining body temperature are clinical thermometers. They offer useful data for evaluating medical problems, permitting prompt medical actions, and guaranteeing the security and comfort of patients.

Clinical thermometers, such as those with enclosed scale designs, are vital medical instruments for taking a patient's temperature precisely and consistently. The term "enclosed scale type" usually refers to the conventional mercury-in-glass thermometers that have been used extensively in households and medical environments.

Enclosed scale thermometers must be handled, calibrated, and disposed of properly to guarantee patient and healthcare provider safety and continuous accuracy.

 

Under IS standard IS 3055 (Part-2): 2004, all clinical thermometers of the Part 2-Enclosed scale type are now required to be part of the ISI Certification Scheme.

Without the ISI Mark, this product cannot be marketed, imported, or exported into the Indian consumer market.

 

About ISI / BIS Certification

Indian Standards Institute, or ISI was renamed the Bureau of Indian Standards (BIS) in 1987. The official mark that the Bureau of Indian Standards provides for manufacturers of various goods is the ISI Mark. It is used to indicate compliance with Indian standards (IS) set by the Bureau of Indian Standards (BIS) and has been used as a conformity marking for industrial products. Manufacturers received permission from BIS to use the ISI Mark on items that comply with relevant Indian requirements through the product certification program. 

Only manufacturers (domestic or foreign) who produce the finished product will be awarded ISI Certification. This will not be given to any product importers, traders, dealers, or distributors.

 

Documents Required for ISI / BIS Certification

The following documentation is required to get an ISI certification:

  • Main Application Form V
  • Address Proof of Manufacturing Unit
  • Details of Manufacturing Process
  • Test Report of products

For more detailed information, please click here.

 

Process of ISI / BIS Certification

There are two approaches for Indian manufacturers to become certified with the ISI Mark:

  • Regular Procedure
  • Simplified Procedure 

 

Regular Procedure

With the possible exception of cases deemed "All India first," which might take up to 180 days, the licensing procedure is expected to be finished in 120 days. This timeline starts on the day the application is received, assuming that at different points in time the documentation, unit assessment, and product conformance are all deemed acceptable.

Step 1: Manufacturing Unit Customization in Compliance with Applicable Indian Standards

  • Identifying the applicable Indian Standard
  • Establishing in-house testing facilities as per the Standard's requirements

Step 2: Submission of the Application Form

  • Preparing an Internal Test Report for the product by the relevant Indian Standard
  • Compiling all necessary documents
  • Completing the Online Application Form
  • Online payment of application fees directly to BIS
  • Submitting hard copies of the Application Form with all enclosures to the relevant Branch Office (BO) of BIS

For more detailed information, please click here.

 

Simplified Procedure

This is a much faster process than the standard procedure. After a factory inspection is deemed satisfactory and the initial evaluation establishes that the sample complies with the applicable Indian Standard(s), the license application process is expected to be finished in 30 days.

Step 1: Adapting the Manufacturing Unit to Comply with the Relevant Indian Standard

  • Identifying the applicable Indian Standard
  • Establishing in-house testing facilities to meet the Standard's requirements

Step 2: Sample Testing

  • Obtaining the necessary certificate for raw materials (Material Test Certificate - MTC)
  • Conducting product sample testing at a BIS-recognized testing laboratory

For more detailed information, please click here

 

ISI Mark Certification Process for Foreign Manufacturers

The process of obtaining ISI Mark Certification for Foreign Manufacturers typically includes the following steps:

Step 1: Application

  • Compile all the required documents.
  • Submit the documents along with the Application Fee.
  • An Application Number will be allotted.
  • Scrutiny of the Application will be conducted within a specified time frame.​

Step 2: Query Raised (If Any)

  • If any documents are missing or there is non-compliance, you will be informed.
  • You need to submit a reply within the given timeframe.

​For more detailed information, please click here.

 

Why choose Brand Liaison?

Brand Liaison provides helpful support for achieving ISI Mark Certification. Among our offerings are:

  •  Expert guidance
  •  Streamline process
  • Comprehensive support
  • Cost-effective solutions
  • Time efficient

Please click here to get in contact with our team of specialists for a deeper explanation of the paperwork and steps needed to get ISI Mark Certification.

 


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