Model Approval in India
At CliniExperts, we ensure that your approval does not extend while you work on launching your product in the market. From the registration process to the approval and documentation, we provide you with a one-stop, quick, and easy experience to ensure a complete application and timely approval.
Model Approval – Overview
A new device or an instrument used to measure or weigh must have the model approved by the Legal Metrology Department. The quality and standards of such devices are inspected and regulated by the Legal Metrology Department under the Ministry of Consumer Affairs. Devices that comply with the OIML standards. A manufacturer or an importer from India can take the approval by applying through the online portal of Model approval
By using these rigorous standards for application of all such devices, the authorities ensure that the products launched in the market abide by the standards set and are safe to use for the consumers.
Who Can Apply?
Any manufacturer or an importer based in India can apply for the model approval.
How To Apply?
The Applicant must follow the following process:
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Registering on the Model approval online portal by submitting the documents according to the standards.
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A detailed brief about the device, with its technical data, sketches, circuits diagrams, etc. should be included in the application procedure.
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The laboratory for testing the device should be selected, and the payment of Government fees of Rs.25000 should be paid through Bharatkosh or by a demand draft.
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After applying, the testing of the device is done in an RRSL lab; the lab will submit a detailed internal report to the Legal Metrology Department.
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The verification of the report will be done, and the application will be accepted or rejected by the Legal Metrology Department.
Validity
The approved license given by the Legal Metrology Department will be valid for a lifetime until any new changes are done to the device.
Fee Involved
The fees for model approval are Rs. 25000, which have to be submitted from Bharatkosh or by a Demand Draft to the Legal Metrology Department.Important Documents
A set of documents required for the application process includes:
- Sketch and drawings of the device
- Photographs of the device
- Circuit diagram
- The complete manufacturing process
- Details of the device component and the material used for its construction
- Details of the brand and the registered trademarks
- The details of the manufacturer
- Full details of the importer
- Company documents (GST number and registered PAN card)
- A list of all the company Directors and their ID proofs
- The address proof of the company
- Communication details of the company (email-id, phone numbers, etc.)
Timeline to get from Central Drugs Standard Control Organisation
90
DAYSEssential Tips
Some essential points are to be kept in mind for the application process:
- Only an Indian entity (an importer or manufacturer) can apply for the model approval.
- During the filing of an application, the technical data of the device is a mandatory requirement.
- Make sure you include the product sketches and the drawings in the application procedure; without the product design, a rejection of the application can be seen.
- The possible problem faced during the application process is the absence of detail of the material used for the device's construction.
- Any absence of assembly diagrams and incorrect or incomplete data for testing can also hinder the approval process.
Expert Advise
The documentation should include all the aspects with the correct document data in the right section. The manufacturing process should consist of flow-wise data with each manufacturing process step.
The circuit diagram of the device should include a brief about the construction and make it easier for the lab to inspect the model according to the testing standards.
Frequently Asked Questions
What are the criteria for Model Photographs?
The captured photograph of the model should be clearly legible. The picture should only include the model in the frame and not any object weighed on it, nor any information regarding the firm or the capacity of the product except any declaration that might be present on the body of the model product itself.
What are the criteria for sealing provisions?
The schematic diagram representation should be adequately visible, with a proper indication that it is for the indicator or the model product. The schematic diagram should clearly represent how the sealing is done on the model. For instance, wires through the model itself, through nuts or bolts, or through the indicator. The schematic diagram should also include:
- The type of sealing
- Location of the sealing
- The type of material used for the sealing i.e.; wire, lead, etc.
- The side of the model/indicator in which sealing is done
What standards must be followed in the case of foreign-manufactured devices?
The model/pattern approved by a foreign country should comply with the OIML (International Organization of Legal Metrology) standards.
How can we alter the application?
While applying, the undertaking must be submitted, stating that no alteration will be made to the submitted model concerning its weight or measuring ability before or after its sale in India.
In which scenarios is a new model approval required?
If there is a change in the material construction, assembly, parts, diagrams, specifications, circuit, etc., the applicant will require a new model approval for the same product.