BIS Certification For Medical Devices

BIS Certification For Medical Devices

Manufacturers/Importers must have a BIS Certification for medical devices. The Bureau of Indian Standards, known as BIS Registration, is essential as it ensures the quality and safety of medical devices and that they adhere to Indian standards.  

What Is BIS Certification For Medical Devices?

BIS Registration Certification for Medical Devices guarantees that the medical devices and all the products follow the standards set by the Government. This certificate shows that the products are adequately safe for consumers.

What is the procedure For Applying for BIS certification for medical devices?

Follow these easy steps to apply for the BIS Certification For Medical Devices:-

  1. Log in to the BIS Online Portal
  2. Now visit the Management System Certification Tab (MSCT)
  3. Now Apply for a BIS Certificate
  4. Fill up the Form
  5. Provide the Needed Documents
  6. Submit Form 
  7. Pay Fees
  8. Inspection 

Documents To Apply For BIS Certification For Medical Devices

Here is the list of documents required for the BIS Certification For Medical Devices:-

  • Registered Address
  • Trademark Proof
  • Product manual of the applied devices
  • Testing documents such as filled CCL and CDF
  • ISO certificate of the manufacturer
  • List of machinery used at the premise
  • Trademark certificate, if available or required
  • Flow chart of the manufacturing process 
  • Laboratory reports         

Also Read: Documents Required for BIS Registration 

Why Is It Mandatory To Apply For BIS Certification For Medical Devices?

Indeed, the BIS Certification for Medical Devices guarantees that medical devices follow standards and are manufactured with proper quality and safety. This certification helps build trust in the consumers and can save them from faulty products that can harm their health. 

Who Needs BIS Certification For Medical Devices?

Besides the 37 Categories, manufacturers and importers of all medical devices should certify them from BIS registration. BIS Registration is crucial for all consumers. It shows that the products are following Indian standards.

Timeline Of BIS Certification For Medical Devices

It depends on the type of products, manufacturing process intricacies, and availability of the documents. It takes five to six months. 

Validity Of BIS Registration Of Medical Devices

BIS Registration of Medical Devices can be valid for two years, and the licensee can renew their BIS Registration certificate, which can be renewed for up to 5 years. Also, manufacturers can renew their medical devices if the standards and product rules they follow are still the same. To register or renew the BIS Registration Certificate for medical devices, you can apply by paying fees online. 

How Much Does Registration For Medical Devices Cost?

BIS Certification For Medical Devices costs are different based on the process. So it is better to talk with the team to ensure all the cost details and services. You can quickly consult directly with the ELT services using the Number mentioned on the website. 

Advantages of Having BIS Certification For Medical Devices

Obtaining BIS Certification For Medical Devices offers many benefits. The list of it is mentioned below:-

  1. Quality Assurance – BIS Certification For Medical Devices assures that the medical items follow standards set for quality and safety. This also offers third-party medical product reliability, quality, and safety guarantees. It is necessary for medical devices. 
  2. Market Trust and Credibility – If medical devices are registered with a BIS Certificate, it helps consumers trust the products. It also helps to build the reputation of your brand.
  3. Regulatory Compliance – BIS Registration is mandatory in the QCO for some medical devices, popularly known as Quality Control Orders. 
  4. Competitive Advantages – If you obtain a BIS Certification for Medical Devices, your brand products can be more trusted in the market than others who do not have them. 

These points illustrate that BIS Certification For Medical Devices is essential and offers various advantages. 

Why Choose ELT For BIS Certification For Medical Devices?

BIS Certification For Medical Devices is mandatory for every manufacturer and importer, so register for it. ELT Corporate is the best service-based company available and does what it says within a given period. Ask all your queries with the Number mentioned at the Top of the page and get a solution in a few seconds. 

Conclusion

After reading the whole blog, We found it obvious why it is necessary, what documents are required, how much time it takes to register, and what the renewal process is. BIS Registration for medical devices in India is compulsory, so register your product. BIS Registration for medical products is crucial as it helps everyone, especially patients.