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End to End Services For

BIS Certification

Trust CliniEpxerts for fully compliant, seamless services

Food
Cosmetic
Medical Device
Diagonostic Kit
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    CliniExperts – Your Obvious Choice As BIS Regulatory Partner


    BIS CRS for Domestic Manufacturer

    BIS Certification for Domestic Manufacturer (ISI Mark)

    BIS Certification for Foreign Manufacturer (ISI Mark)

    BIS CRS for Foreign Manufacturer

    Endorsement of Certification for Domestic Manufacturer (ISI Mark)

    Renewal of Certification for Foreign Manufacturer (ISI Mark)

    Endorsement of CRS for Domestic Manufacturer

    Modification and Amendment of CRS for Foreign Manufacturer

    Modification and Amendment of Certification for Domestic Manufacturer (ISI Mark)

    Streamline regulatory compliance with CliniExperts. We offer BIS certificate, CRS, and modification services. Our personalized solutions, streamlined process, and timely results ensure hassle-free BIS Registration compliances. Contact us today for efficient BIS regulatory consulting tailored to your needs.

    About BIS?


    Since 1987, the Bureau of Indian Standards or BIS has been fostering a culture of quality, reliability, and safety amongst a plethora of Indian products. Thanks to this apex standardization body, consumers are assured of product integrity and high standards for safe and reliable consumption. The governing body of BIS is inclusive and diverse, consisting 25 members from the federal and state governments, MPs, professionals from different domains, industry representatives, scientific and research firms, consumer organisations, and the like. The central minister of consumer affairs and its minister of state preside as BIS’ president and vice-president, respectively. Apart from product certification, BIS regularly updates standards to retain their market relevance, nforcs conformity assessment schemes, recognizes and operates testing and analyses laboratories, undertakes, and other world standardization bodies.
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    Other Contributing Factors

    Product Categories Associated

    Food

    • The Food Safety and Standards Regulations, 2011 has made BIS certification mandatory for infant formulas, packaged drinking water, milks of different categories, processed cereals, and many other products. Full list here.
    • Also, Indian Standards on Plastics (packaging) apples to 10 categories. Full list here.

    Cosmetics

    • As many as 30 Indian Standards on finished cosmetics apply to products listed in Schedule “S” of the Drugs and Cosmetics Rules, 1945.
    • Moreover, IS 4707 part 1 and 2 apply for cosmetics raw materials, adjuncts, and colourants. Full lists here.

    Medical devices

    • BIS’ technical committee, Medical Equipment and Hospital Planning Department or MHD oversees proper manufacturing and functioning of various categories such as surgical equipment, implants and accessories, electro-medical and forensic equipment and wearables, medical laboratory equipment, and healthcare and treatment products.
    • Further, under IS 23485, Quality Management System requirements are laid out for safety and performance of medical devices.

    IVD's

    • The Medical Devices Rules, 2017 regulate clinical investigation, manufacture, import, sales, and distribution of medical devices and IVDs. These rules are applicable to substances used for in-vitro diagnostics and surgical dressings. Full list and other details here.

    Types of Services

    For Importers

    For Manufacturers

    Why Choose CliniExperts?


    For over 13 years, we have been providing full-spectrum services for all aspects covering healthcare regulatory and compliance domains in India. Hence, when you entrust us as your BIS partner, you get:
    • Services trusted by our customers
    • Top-notch talent and experienced staff to handle your case
    • Timely and satisfactory services
    • Fully compliant, market-ready licensing and registration
    • 24/7 response while your case is under process
    • Deep understanding and knowledge of all licensing processes; hence error-free completion
    • Resourcefulness – You can depend upon us for efficient and effective handling of your case throughout the BIS licensing funnel.
    Call CliniExperts to discuss your requirements, and our CS executive will be delighted to assist you!
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    Testimonials

    The Brand That Promises To Turn, Your Business Around!

    Atomy India Pvt ltd

    We have been associated with CliniExperts for about a year now for our food products related services for FSSAI compliances and licenses from CliniExperts and are completely satisfied with their performance. Quick turnaround time in responding to queries, meticulous planning in completing the task, alongside the extensive knowledge of the regulations of the entire team is highly appreciable and marks the professionalism and quality driven ethics of the organization. We highly recommend their services as we believe it is best in the industry so far.


    Rajeev Rattava

    Finance Manager

    Morepen Laboratories Ltd.

    The team at CliniExperts is proficient in the subject matter and provide prompt services . We are satisfied with our engagement and would recommend their services.


    Anubhav Suri

    Business Head

    Proficon Medisol Pvt. Ltd.

    We have been professionally associated with Cliniexperts for more than 5 years now. They have smoothly sailed us all these years in different projects & this has been possible because of the knowledge & dedication cliniexpert team has in their portfolio. All the best Cliniexpert. Keep going.


    Ajitesh Trehan

    Director

       

    Frequently Asked Questions

    Which products require registration?

    The manufacturer must register their products which come under the Compulsory Registration Scheme (CRS) category as per the Bureau of Indian Standards (BIS) guidelines.

    Are products which are tested from laboratories excluding the Bureau of Indian Standards (BIS) - approved laboratories acceptable?

    No, products which require the grant letter with unique R – number and IS standard under the Compulsory Registration Scheme (CRS) category must be tested from Bureau of Indian Standards (BIS) - approved laboratories.

    Is the Bureau of Indian Standards (BIS) license mandatory to import products to India?

    Generally, the certification scheme of the Bureau of Indian Standards (BIS) is voluntary in nature.  However, some products (notified by the Government of India under Quality Control Orders)can be imported to India provided they have an Indian Standard (IS) mark logo and a valid license from the Bureau of Indian Standards (BIS).

    Will the IS Standard mark logo be present on the product or its packaging?

    The IS Standard mark logo will be placed on both the product and its packaging. - However, if it is not feasible to place the IS standard mark logo on the product (due to size constraints), it can only be placed on its packaging. - For products with a display screen, provisions for E - labelling are also available.

    Is nomination of the Authorized Indian Representative (AIR) mandatory?

    Yes, the foreign manufacturer must nominate an Authorized Indian Representative (AIR).

    Can product samples drawn during inspection be tested in laboratories approved by the International Laboratory Accreditation Cooperation (ILAC)/Asia Pacific Laboratory Accreditation Cooperation (APLAC)/government-owned laboratories in the country of the manufacturer?

    No, product samples drawn out during inspection must only be tested in laboratories approved by the Bureau of Indian Standards (BIS).   The applicant must send the product samples drawn by the Bureau of Indian Standards (BIS) to the laboratory. The product testing charges must be borne by the applicant.