BIS ISI Certification for X-ray Equipment (Part 1) 

X-ray Equipment - Part 1 for the Indian Market: An Insight

The "X-ray equipment", which has now become a common product in almost all diagnostic centres and medical sites, is efficiently used to create and record images of the interior of the body for diagnostic reasons. For X-ray equipment (Part 1) in India, business demand is moving up steadily at around ~5–7% each year, and these machines account for roughly ~4–6% of the medical equipment market, as hospitals and diagnostic centres invest only in fully approved systems to meet strict safety rules before use. Imaging techniques have improved with time, becoming safer, more effective, and more exact, which is good news for patients and healthcare professionals alike. The X-ray equipment has to be compliant, as it is essential that the safety and performance of these are assured before they are made available in the wider market. 

Key Highlights 

What is the Required Certification for X-ray Equipment in the Indian Market?

BIS ISI Certification is compulsory for X-ray Equipment - Part 1 to enter the Indian market. Let’s walk through the process, required paperwork, as well as major guidelines.

BIS ISI Mark Certificate 

There are strict regulations to assist in the sale of X-ray equipment in India, which is why BIS/ISI certification is compulsory. By testing and evaluation, the Bureau of Indian Standards (BIS) certifies the ISI mark on the equipment that satisfies the vital requirements of performance and safety for the equipment users. A BIS certificate, mandatory for X-ray equipment to sell in India, is not only a process of quality assurance, but it is also a legal necessity for manufacturers and importers. The stated standard addresses a number of issues, such as design, shielding, warning signs, and control mechanisms that are needed to provide appropriate radiation shielding. 

What happens if you sell in India without having an ISI mark registration? Read here in detail.

How to Get BIS Certification for X-ray Equipment - Part 1 in India? 

Required Documents for BIS License for X-ray Equipment - Part 1 

Accurate and complete documentation is essential for obtaining BIS certification. Manufacturers and importers must prepare all required documents beforehand to avoid delays and ensure a hassle-free application process:

1. Legal address proofs of the factories
2. Product specification
3. Details of raw material, machinery, and testing equipments
4. Details of QC Staff and other basic details of the factory
5. Lab test reports of the product
6. Main Application Form V
7. ISI Application Fee
8. Appointment of AIR (Authorized Indian Representative) in case you are a foreign manufacturer

Process to get an ISI mark Registration for X-ray Equipment - Part 1 

Whether you're a domestic producer or a global brand, adhering to the outlined steps will help you secure BIS ISI mark certification efficiently and without complications. Have a look at the steps mentioned below:

1. Prepare Documents
2. Submit Application
3. Factory Inspections by BIS Officials
4. Product Testing

Certification Guidelines For Indian Manufacturers

• Must have proper manufacturing and testing capabilities for the product.
• Apply through the BIS Manak portal with all required documents.
• Product samples are tested in a BIS-accredited lab.
• License is granted if test results and documents meet the Indian standards set by the Bureau of Indian Standards.

Certification Guidelines For Foreign Manufacturers

• Must appoint an Authorized Indian Representative (AIR) as per BIS guidelines.
• Submit application with Factory Test Report (FTR).
• BIS conducts factory inspection and selects samples for testing.
• A license is issued after successful testing and compliance with standards.

Need complete knowledge about the certification? Click to view the complete guidebook for a BIS license. 

Certification Guidelines For Indian Importers

• Not eligible to apply directly; only manufacturers can obtain BIS ISI certification.
• Must coordinate with the manufacturer to get the certificate.
• Keep a copy of the license to avoid customs issues.
• Can act as AIR if authorized by the manufacturer.

Certification Guidelines For Traders

• Cannot apply for BIS ISI certification directly.
• Certification must be obtained by the manufacturer.
• Maintain a copy of the license for compliance.
• Can act as AIR if authorized.

Certification Guidelines For Online Sellers

• Not eligible to apply directly; only original manufacturers can apply.
• Must obtain the BIS ISI certificate copy from the manufacturer.
• Required to present certification for e-commerce compliance.

Visit here to check your eligibility for the X-ray Equipment - Part 1 for the Indian market now! 

How Brand Liaison Assists Businesses in Obtaining Seamless Compliance?

• Brand Liaison, as a reliable BIS Consultant, assists companies in adhering to national and international regulations by offering their in-depth understanding of regulatory needs.
• They develop specialized compliance plans based on the unique requirements of a company, guaranteeing seamless operations free from legal obstacles.
• By managing intellectual property and obtaining patents and trademarks, they shield the company from possible legal issues and infringement.
• BIS Consultancy services lower the risk of fines by keeping operations in line with evolving rules through monitoring and evaluating the company's compliance status.
• Brand liaison makes the process of acquiring licenses and permits easier and guarantees that all legal paperwork is for business operations to run smoothly. For assistance, you can contact the Brand Liaison to ensure everything is handled efficiently.

Get in touch with Brand Liaison and ensure that your products are meeting the required standards and market benchmarks. Our team will guide you in obtaining a BIS license in a hassle-free way.