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.

BIS Certificate 

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.

  • It provides a safeguard to public health
  • It provides quality assurance
  • It protects the consumer from hazardous products
  • It promotes consumer confidence

Benefit of BIS certificate 

  • strong evidence of the product’s quality.
  • Ensures better utilization of resources.
  • Facilitate global recognition, thereby ensuring access to untapped and overseas markets.
  • BIS Certifications allow the license holder to put an ISI mark on their product which in turn gives assurance of the good quality of the product.
  • BIS registration is granted after testing product samples in BIS-established laboratories, which guarantees quality control and high-quality products.

Are BIS Certifications Valid for Medical Devices?

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.

Types Of Certification

  • Indian Standard Institute (ISI)
  • Compulsory Registration Scheme (CRS)
  • Foreign Manufacturing Certificate Scheme (FMCS)

However, because these certification programmes are only applicable to medical devices, we will only discuss the ISI and FMCS certification programmes .

Indian standard institute (ISI)

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.

How Can Medical Devices Obtain BIS Certification? (FMCS and ISI)

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 Process ISI Certification 

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.

FMCS Certification Process 

  • Complete an application form
  • industry inspection for a fee
  • testing of product samples
  • Minimum marking fee and licence fee
  • issuing a certificate and paying the performance bank    

  (FIGURE 2)

  • A required  document will be properly completed on application form 
  • A required fee must be paid before a factory inspection can take place.
  • A product sample will be taken out during factory inspection.
  • If the product sample and factory inspection meet the required standards, the registration will proceed.
  • Before the grant of the licence, a licence fee and an advance minimum marking fee will be submitted.
  • A grant of licence will be given following the completion of the payments, the signing of the indemnity agreement, and the payment of the $10,000 Performance Bank Guarantee.
  • An FMCS certificate is given out if a product complies with the requirements.

BIS Role In Medical Device Registration 

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 .  

Document Required For BIS Certificate 

  • Name and address proof of office and industry as per aadhar and pan )
  • Documents verifying the manufacturing unit’s establishment, such as a MAO and incorporation certificate or registration certificate
  • certificate for MSME/SSI, if applicable
  • All production process are included in the manufacturing process flow (from raw material to finished product stage)
  • The list of manufacturing equipment and its specifications
  • If applicable, specifics regarding the outsourcing of the manufacturing operation
  • A complete list of testing locations and testing equipment
  • Copies of current calibration certificates for testing equipment
  •  Third-party laboratory test report that complies with Indian Standards
  • Layout of the factory’s grounds and a map showing its location (site location map )
  • Report of internal or outside testing, as appropriate
  • The application is signed by the authorised signatory, and the CEO issued an authorization letter in the signatory’s name.
  • foreign manufacturer or an international applicant, nomination information for an Indian agent and a nomination form

BIS Standards are Required for Medical Devices

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:

  1. Reference country approval .
  2. ISO 13485 certificate of the manufacturing facility 

Conclusion 

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.