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In today's competitive landscape, maintaining market presence without a certified, high-quality product can be challenging. Obtaining a BIS license may also be essential for selling products in the Indian market. To achieve BIS certification and ensure product quality, manufacturers must adhere to the specified Indian standards.
Let's delve deeper into at IS 17945: 2022 For Food for Special Medical Purpose intended for Infants
BIS certification for Food for Special Medical Purpose (FSMP) intended for infants under IS 17945:2022 ensures the product adheres to stringent safety and quality standards. FSMP products are specially formulated to meet the specific dietary needs of infants with medical conditions or special nutritional requirements. The certification regulates all aspects of production, including ingredient selection, processing, packaging, and labeling, ensuring that these products are safe, effective, and nutritionally balanced. By complying with IS 17945:2022, manufacturers and importers can legally market FSMP products for infants in India while gaining the trust of healthcare professionals and caregivers.
| Product Name | Special Medical Purpose intended for Infants |
| Applicable Indian Standard | IS 17945: 2022 |
| Applicable Certification Scheme | Product Certification Scheme (ISI Mark Scheme) Scheme 1 - Schedule 2 |
| Compliance Requirement | Mandatory |
| QCO Link | Quality Control Order |
Here are the key benefits of getting ISI Mark certification:
Government Quality Assurance: The ISI mark indicates that a product meets the quality standards established by the government, ensuring compliance and reliability.
Mandatory Compliance: It is mandatory for Food for Special Medical Purpose intended for Infants to obtain the ISI Mark. Non-compliance can result in penalties, including material seizure and substantial fines.
Enhanced Market Competitiveness: Achieving certification significantly enhances your product's chances of success in the competitive market.
Consumer Trust: Consumers are more likely to purchase ISI-certified products, as they guarantee safety and quality. This certification helps build trust and confidence among buyers.
Market Benchmarking: Partnering with a respected brand allows you to elevate industry standards and establish a benchmark for your product's market value.
Acquiring a BIS license requires a comprehensive review of manufacturing infrastructure, quality control abilities, testing resources, and production procedures. This thorough assessment guarantees that products not only adhere to regulations but also prioritize consumer safety and reliability.
For comprehensive guidance on the BIS ISI Certification process, please explore:
Absolute Veritas is a prominent organisation from the private sector of India primarily dealing with the Inspection, Testing, Audits, Certification of products& consulting services to various industries in India and worldwide, ensuring compliance with regulatory standards and industry requirements. Offering a comprehensive range of services including product certification, testing, training, auditing, and compliance services, Absolute Veritas helps manufacturers and importers achieve higher production efficiency and quality standards.
Absolute Veritas (BIS Consultant) will handle end to end pre-registration request, sample preparation, documentation, testing and application process for FMCS Certification
For any questions regarding the most recent update on FMCS registration licenses, please reach out to us via email at cs@absoluteveritas.com
BIS certification is mandatory because FSMP products are consumed by infants with sensitive health conditions and specialized dietary requirements. Compliance with IS 17945:2022 ensures these products are safe, effective, and nutritionally adequate, protecting infant health and preventing the circulation of substandard or unsafe products in the market.
All domestic manufacturers and foreign manufacturers or importers supplying FSMP products intended for infants in the Indian market must obtain BIS certification. Foreign manufacturers must apply under the Foreign Manufacturers Certification Scheme (FMCS) to legally sell their products in India.
BIS certification evaluates ingredient selection, nutritional formulation, microbiological safety, contaminants, processing conditions, quality control systems, packaging integrity, and labeling accuracy. These checks ensure the FSMP product is safe, effective, and nutritionally balanced for infants with special medical needs.
The BIS Quality Control Order mandates that Food for Special Medical Purpose intended for infants must conform to IS 17945:2022 and carry a valid ISI Mark. Products failing to comply with the QCO are prohibited from manufacture, import, sale, or distribution in India.
The BIS certification process includes application submission, documentation review, product sample testing in BIS-recognized laboratories, assessment of manufacturing infrastructure and quality control systems, and an onsite inspection by BIS officials. Upon successful compliance, a BIS license is granted to use the ISI Mark.