Surgical Gloves ISI Registration

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BIS ISI Registration for Surgical Gloves

The Bureau of Indian Standards (BIS) plays a crucial role in regulating the quality, safety, and reliability of manufactured goods in India. ISI registration is essential for manufacturers of surgical gloves to adhere to Indian regulations and standards equivalent to global quality parameters. This certification, issued by BIS, acts as a mark of quality and safety, contributing to a strong brand image for manufacturers. What is BIS ISI Registration for Surgical Gloves: BIS ISI Registration for Surgical Gloves involves obtaining a certificate from the Bureau of Indian Standards, confirming that the product meets necessary quality standards and safety guidelines. This certification aims to protect consumers from substandard or hazardous products by regulating their quality. It establishes a framework for manufacturers to meet the required standards, ensuring the dependability, performance, and safety of surgical gloves. BIS certification boosts consumer confidence and promotes fair trade practices.

Procedure of BIS ISI Registration for Surgical Gloves:

Identification of IS standard: Determine the appropriate quality standards for the product before applying for ISI registration.
Documentation and Filing: File an online application with BIS licensing authorities, providing necessary details.
Verification and inspection: BIS conducts verification and inspection to ensure compliance.
Issuance of BIS certificate: Successful completion leads to the issuance of the ISI Certification.

Setting Up In-house Lab - For ISI Registration for Manufacturers: Manufacturers must have an in-house lab for obtaining ISI certification for their products. The lab must possess necessary machinery and testing equipment for product testing. An initial test should be conducted at the manufacturing plant to ensure compliance with Indian standards. Professional Utilities assists in setting up an in-house lab.

Requirements for Setting up In-House Lab for Manufacturers:

Testing parameters: Thickness, pH of Aqueous Extract, Dimensions, Elongation at Break, Tensile Strength.
Equipments Required: Humidity Chamber, Universal Testing Machine, Vernier calipers, Oven, Balance, Incubator.
Note: Few other test parameters and equipment can also be required for the setting up of an Inhouse lab facility.

Fee for ISI registration of Surgical Gloves:

Application Fee: ₹1,000
Sample Test Fee: As applicable
License Fee: ₹1,000
Inspection Charge: ₹7,000
Professional Fee: Starts from ₹40,000

Note: For micro-scale businesses, the government offers concessions of up to 80%, while small and medium-scale businesses can avail themselves of a 20% concession on ISI marking fees.

Benefits of BIS ISI Registration:

Increase Brand Value and Customer Confidence: ISI registration signifies quality and safety, enhancing brand value and customer confidence.
Reduce Risk of Product Recalls and Penalties: ISI registration minimizes the risk of product recalls and penalties for non-compliance.
Access to Government Tenders and Contracts: ISI registration is a requirement for many government tenders and contracts, providing access to opportunities.
Improved Market Access: ISI registration improves market access, making products eligible for sale in more markets.
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Required Document List

  • List of raw materials used
  • Factory location details
  • Description of the manufacturing process
  • Details of machinery
  • Detailed plant layout
  • In-house lab for initial quality checkups
  • Test report from a BIS recognized Laboratory
  • Photograph of the product
  • Undertaking
  • Application form
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