Bureau of Indian Standards (BIS) Certification holds immense significance in ensuring quality and compliance for products circulating within India. Established under the Bureau of Indian Standards Act, of 1986, BIS is the national body that formulates standards and certifies products for quality, safety, and reliability.
The Bureau of Indian Standards (BIS) in India is functioning under Ministry of Consumer Affairs . It is responsible for grant of BIS certification. The BIS certification signifies a third party, i.e., BIS, assuring to customers the quality, dependability, and safety of any product. The BIS is involved in a number of activities, such as product certification, quality control, testing, hallmarking, calibration schemes, etc.
BIS Certifications are valid for two years According to factory inspection and product testing, BIS is a body that ensures that a product must adhere to the rules and issues certificates.
However, because these certification programmes are only applicable to medical devices, we will only discuss the ISI and FMCS certification programmes .
A certificate program called ISI certification is available to Indian manufacturers working on goods that fall under BIS’s purview. It assures that a product complies with Indian safety requirements. To ensure that a product complies with Indian standards, FMCS is, however, applicable to foreign manufacturers. Although the products covered by both certification programmes are somewhat comparable, their certification procedures vary wildly.
Compared to FMCS, the ISI certification process is much simpler because it involves more on-site activities, such as client travel to their destination country, customs clearance, product delivery to India, and other things. FMCS is comprehensive because of these off-shore activities that it incorporates.
As said before, ISI and FMCS certificates must be obtained in order to sell, distribute, and import medical devices into India. The BIS certification procedure for both certificates is mentioned here.
Application filling——— Industry Inspection———Sample testing———Product test report review————- ISI certificate grant figure 1
An application form will be submitted.
Application form filled as per guideline a industry inspection will be conducted of manufacturing assessment and quality control .
Product samples will be taken during industry inspection for testing at certified laboratories.
The product sample test report will be investigated.
If industry inspection and product samples fulfil the defined guidelines, an ISI certificate will be issued.
The Bureau of Indian Standards’ role in relation to medical devices is to maintain the healthcare system and to keep an eye on the calibre of equipment used in the medical industry to ensure that it is being used appropriately and in accordance with BIS-approved safety protocols. In medical device role utilised as per set indian standard of technical committee established by BIS that the work under the medical equipment ,hospital planning department ,for such as medical devices i.e CT- Scan ,pet Scan ,MRI ,X-ray,weight machine, medical laboratory equipment, research laboratory, surgical equpment , veterinary products need the BIS certificate .
Only 38 different kinds of medical equipment must currently obtain an import licence (Form MD-15) from India’s Central Drugs Standard Control Organisation (CDSCO) before being sold. All risk Class A and B medical devices will need to have an import licence as of October 1, 2022. The same requirement will apply to all risk Class C and D medical devices. All non-Notified medical devices must be registered in the interim. India’s licencing requirements for medical devices include:
I hope that all of your questions and concerns about obtaining a BIS certification for medical devices have been answered. If not, we are still available to you for BIS certification.
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