BIS certification for Medical devices: A step-by-step guide

Introduction 

In the rapidly advancing world of medical technology, ensuring the safety, reliability, and effectiveness of medical devices is paramount. Medical devices are critical for patient care, and therefore, they must meet stringent quality and safety standards. In India, the Bureau of Indian Standards (BIS) plays a crucial role in setting these standards and regulating the quality of medical devices available in the market. BIS certification for medical devices ensures that they are safe for use and comply with the necessary regulatory requirements. In this comprehensive guide, we will walk you through the BIS certification process for medical devices, its importance, and the steps required for businesses to comply.

What is BIS Certification for Medical Devices?

BIS certification is a mandatory process in India for ensuring that products meet the safety, performance, and quality standards set by the Bureau of Indian Standards (BIS). For medical devices, this certification confirms that the product complies with the essential requirements regarding safety, efficacy, and quality standards outlined in the Medical Device Rules 2017. These rules, which came into effect in India in 2017, stipulate that manufacturers must ensure their medical devices comply with specified Indian standards (IS) before they are sold in the market.

Obtaining BIS certification for medical devices is not just about compliance with legal requirements; it is also a significant step in gaining the trust of consumers and healthcare professionals. For manufacturers, this certification provides assurance that their products are of high quality, safe for use, and meet the performance criteria as per regulatory guidelines. BIS standards cover a wide range of medical devices, from diagnostic tools to surgical instruments, implants, and more.

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Why is BIS Certification Important for Medical Devices?

The importance of BIS certification for medical devices cannot be overstated. 

IS 23485 Certification refers to a standard set by the Bureau of Indian Standards (BIS) for the manufacture, quality, and safety of certain products in India. Specifically, IS 23485 is related to “Requirements for Domestic Cooking Ranges”. A strategist helps companies navigate the IS 23485 certification by ensuring compliance with safety and quality standards, optimizing processes, and liaising with BIS. They also assist in preparing for audits, training staff, and leveraging the certification for marketing and competitive advantage.

Below are some key reasons why obtaining this certification is essential for medical device manufacturers and suppliers:

1. Ensures Patient Safety: BIS certification ensures that medical devices meet strict safety and quality standards, which is crucial for protecting patients and healthcare providers from potential risks and hazards.
2. Regulatory Compliance: Medical devices must comply with India’s regulatory requirements. Obtaining BIS certification ensures that your product meets the guidelines set forth by the Medical Device Rules 2017 and other relevant standards.
3. Market Access: BIS certification is a prerequisite for selling medical devices in India. Without this certification, manufacturers cannot legally distribute or sell their products in the Indian market.
4. International Recognition: Having BIS certification can open doors to global markets. Many countries recognize the ISI mark (the mark given by BIS), which helps businesses in their international export endeavors.
5. Trust and Credibility: For healthcare providers and consumers, BIS certification instills confidence in the product’s safety, reliability, and performance. It enhances the reputation of manufacturers and boosts their credibility in the market.

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BIS Certification Process for Medical Devices

The BIS certification process for medical devices involves ensuring that the product meets specific safety, quality, and performance standards set by the Bureau of Indian Standards, as follows:

1.Determine the Product Classification – Identify if the medical device falls under BIS-mandated categories and confirm applicable standards (e.g., IS 15579 for surgical instruments).

2. Submit Application to BIS – Apply through the BIS portal under the applicable certification scheme (e.g., CRS or FMCS) with required documents like test reports and company details.

3. Product Testing & Evaluation – Conduct testing at BIS-approved laboratories to ensure compliance with Indian Standards. BIS reviews test reports for approval.

4. Factory Inspection & Quality Control – BIS officials inspect the manufacturing facility to assess quality control measures. Upon successful verification, BIS grants certification.

Post-Certification Compliance

After obtaining BIS certification, manufacturers must maintain compliance with BIS standards through:

• Regular quality checks and testing: Ensures products continue to meet safety, quality, and performance standards.
  
• Periodic factory inspections by BIS: Verifies ongoing compliance with manufacturing processes.
  
• Renewal of certification: Manufacturers must renew the BIS certification after a specified period to maintain validity.
  
• Failure to maintain compliance: Non-compliance can lead to the revocation of the certification, impacting product legality and market reputation.

RegisterKaro offer post-certification support to ensure your business continues to meet regulatory requirements. Contact us todsay!

Conclusion

BIS certification for medical devices is a crucial process for manufacturers looking to sell their products in India. It ensures that the medical devices meet strict safety, performance, and quality standards, ultimately protecting patient health and improving the trustworthiness of medical products. By following the step-by-step process outlined in this guide, manufacturers can navigate the certification journey smoothly and efficiently.

At RegisterKaro, we specialize in helping businesses obtain BIS certification for their medical devices. From application submission and product testing to factory inspections and ongoing compliance, we provide end-to-end services tailored to your needs. Contact RegisterKaro today to ensure your medical device meets all necessary standards and is ready for the Indian market!

Frequently Asked Questions (FAQs)

1. Is BIS Certification Mandatory for All Medical Devices?
No, BIS certification is mandatory only for certain medical devices listed under the Compulsory Registration Scheme (CRS) or ISI Mark Certification.

2. How Long Does It Take to Obtain BIS Certification for Medical Devices?
The BIS certification process typically takes 30 to 90 days, depending on the complexity of the product and testing requirements.

3. Can Foreign Medical Device Manufacturers Apply for BIS Certification?
Yes, foreign manufacturers must appoint an Authorized Indian Representative (AIR) to apply for BIS certification in India.

4. What Happens If I Sell a Medical Device Without BIS Certification?
Selling non-certified medical devices can result in penalties, product recalls, and legal action under the BIS Act, 2016.

5. What Is the Difference Between BIS Certification and ISO 13485?

• BIS Certification ensures compliance with Indian standards for safety and quality.
• ISO 13485 is an international standard for medical device quality management systems.

6. Do Importers Also Need BIS Certification for Medical Devices?
Yes, importers must ensure BIS certification compliance before selling medical devices in the Indian market.

7. How Can RegisterKaro Help with BIS Certification for Medical Devices?
RegisterKaro provides end-to-end BIS certification assistance, including documentation, application filing, factory audits, and product testing support.