Everything You Need to Know About BIS CRS Registration for IT and Electronic Products

 India has become one of the fastest-growing markets for electronic and IT products. With rising consumer demand comes the responsibility of ensuring product safety, quality, and compliance. To regulate this rapidly expanding sector, the Government of India introduced the BIS CRS Registration system. If you are a manufacturer, importer, or brand owner dealing with electronic or IT products, understanding BIS CRS registration is essential for legally entering and operating in the Indian market.

This blog explains everything you need to know about BIS CRS Registration in a simple, practical, and business-friendly manner.

Introduction to BIS CRS Registration

BIS CRS Registration refers to the Compulsory Registration Scheme (CRS) implemented by the Bureau of Indian Standards (BIS). Under this scheme, certain electronic and information technology products must be registered with BIS before they can be manufactured, imported, sold, or distributed in India.

The primary objective of BIS CRS registration is to ensure that electronic products meet Indian safety standards and do not pose risks to users. Products covered under CRS must comply with specific Indian Standards (IS) and undergo testing at BIS-recognized laboratories.

Once approved, manufacturers are allowed to use the Standard Mark on their products, signifying compliance with Indian safety and quality norms.

Why BIS CRS Registration Is Important

BIS CRS registration is not optional—it is a mandatory legal requirement for notified products. Operating without it can lead to serious consequences.

1. Legal Market Access

Without BIS CRS registration, electronic products cannot be legally sold or imported into India. Customs authorities may detain or reject non-compliant shipments.

2. Consumer Safety Assurance

CRS ensures that products meet electrical and fire safety standards, reducing the risk of accidents, malfunctions, or hazards.

3. Brand Trust and Credibility

Products bearing the BIS Standard Mark build consumer confidence and enhance brand reputation in the Indian market.

4. Avoidance of Penalties

Selling or importing non-registered products can result in fines, seizure of goods, cancellation of business licenses, and legal action.

Products Covered Under BIS CRS Scheme

BIS CRS registration applies to a wide range of electronic and IT products, including but not limited to:

• Mobile phones and smartphones
  
  

• Laptops and tablets
  
  

• Power adapters and chargers
  
  

• LED lights and luminaires
  
  

• Smart watches and wearables
  
  

• Televisions and monitors
  
  

• Set-top boxes
  
  

• Electronic toys
  
  

• Audio and video equipment
  
  

The list of products under CRS continues to expand, making it crucial for businesses to verify applicability before entering the market.

Who Needs BIS CRS Registration?

BIS CRS registration is required by entities involved at different levels of the supply chain.

Manufacturers (Indian and Foreign)

Any manufacturer producing notified electronic products for sale in India must obtain BIS CRS registration. This applies to both domestic and overseas manufacturers.

Importers

Importers bringing electronic products into India must ensure that the manufacturer holds a valid BIS CRS registration.

Brand Owners

If products are sold under a specific brand name, the brand owner is also responsible for ensuring compliance.

OEMs and Private Label Sellers

Even if manufacturing is outsourced, registration is still mandatory under the manufacturer’s name with brand endorsement.

Documents Required for BIS CRS Registration

Proper documentation is critical for a smooth and timely approval. Commonly required documents include:

Manufacturer Details

• Business registration certificate
  
  

• Address proof of manufacturing unit
  
  

• Manufacturing process flow chart
  
  

Product-Specific Documents

• Product technical specifications
  
  

• Circuit diagrams and component details
  
  

• User manual and safety instructions
  
  

Test Reports

• Product testing report from a BIS-recognized laboratory
  
  

• Test report must match applicable Indian Standard (IS)
  
  

Authorization Documents

• Authorization letter from the manufacturer
  
  

• Authorized Indian Representative (AIR) details for foreign manufacturers
  
  

Brand and Labeling Details

• Brand authorization (if applicable)
  
  

• Label artwork showing BIS Standard Mark placement
  
  

Incomplete or incorrect documents are one of the most common reasons for application rejection or delay.

BIS CRS Registration Process

The BIS CRS registration process involves multiple steps that must be followed carefully.

Step 1: Product Testing

The product is tested at a BIS-recognized laboratory to ensure compliance with the applicable Indian Standard.

Step 2: Online Application Submission

The manufacturer submits the CRS registration application along with documents and test reports through the BIS portal.

Step 3: Document Verification

BIS officials review the application, technical documents, and test results.

Step 4: Grant of Registration

Once approved, BIS issues the CRS Registration Certificate, allowing the use of the Standard Mark on the product.

Fee Structure and Timeline

BIS CRS Registration Fees

• Application fee per product
  
  

• Registration fee
  
  

• Additional charges for testing (lab fees vary by product)
  
  

Timeline

• Product testing: 1–3 weeks
  
  

• Application review and approval: 2–4 weeks
  
  

• Total estimated timeline: 4–8 weeks
  
  

Delays may occur if documents are incomplete or test reports require correction.

PSR Compliance Assistance

Due to the technical and regulatory nature of BIS CRS registration, professional compliance support plays a crucial role in ensuring success.

Expert assistance helps with:

• Product applicability assessment
  
  

• Coordination with BIS-approved laboratories
  
  

• Accurate document preparation
  
  

• Application filing and follow-ups
  
  

• Post-registration compliance management
  
  

This reduces rejection risks and ensures faster approval.

🔗 For detailed guidance and professional assistance, visit:
https://www.psrcompliance.com/bis-crs-registration

MD-42 License in India: A Complete Compliance Guide for Medical Device Sellers

India’s medical device sector is growing at a rapid pace, driven by rising healthcare needs, technological advancements, and increased awareness of quality medical products. With this growth comes strict regulatory oversight to ensure patient safety and product reliability. One of the most important regulatory requirements for businesses dealing in medical devices is the MD-42 License in India.

Whether you are a retailer, wholesaler, distributor, or an online seller of medical devices, obtaining an MD-42 license is not just a legal formality-it is a mandatory compliance requirement under Indian medical device laws. This article explains everything you need to know about the MD-42 license in a clear, humanized, and easy-to-understand manner.

Introduction to MD-42 License in India

The MD-42 License is issued under the Medical Devices Rules, 2017 and is granted by the respective State Licensing Authority through the CDSCO regulatory framework. This license acts as a registration certificate that allows businesses to legally sell, stock, distribute, or exhibit medical devices in India.

As per recent regulatory updates, most medical devices—especially those falling under Class B, Class C, and Class D categories—require sellers and distributors to be registered. The MD-42 license is issued after submitting Form MD-41, along with the prescribed documents and fees.

The government introduced this licensing system to bring transparency, traceability, and accountability into the medical device supply chain. With increasing use of online platforms and e-commerce for selling medical devices, MD-42 registration has become even more critical for businesses looking to operate smoothly without legal interruptions.

Advantages of Obtaining an MD-42 License

Getting an MD-42 license offers several important advantages that go beyond basic compliance.

1. Legal Authorization to Operate

The most significant advantage is that it legally authorizes your business to sell and distribute medical devices in India. Operating without an MD-42 license can lead to penalties, seizure of goods, or cancellation of business operations.

2. Access to Online Marketplaces

Major e-commerce platforms require sellers of medical devices to upload valid regulatory licenses before allowing product listings. An MD-42 license ensures uninterrupted access to these platforms and helps businesses scale digitally.

3. Increased Business Credibility

Holding an MD-42 license enhances your reputation among customers, hospitals, clinics, and business partners. It reflects your commitment to regulatory compliance, product safety, and ethical business practices.

4. Participation in Government and Institutional Tenders

Many government healthcare projects, hospital procurements, and institutional tenders require vendors to hold valid medical device licenses. An MD-42 license enables you to participate in such opportunities.

5. Better Quality and Compliance Control

The licensing process ensures that your storage conditions, record-keeping systems, and distribution practices meet regulatory standards. This improves overall operational efficiency and reduces compliance risks in the long term.

Who Needs an MD-42 License?

The MD-42 license is required by a wide range of businesses involved in the medical device supply chain.

Medical Device Retailers

Any shop, pharmacy, or clinic selling medical devices directly to consumers needs an MD-42 license if the devices fall under regulated categories.

Wholesalers and Distributors

Businesses involved in bulk purchasing and redistribution of medical devices to retailers, hospitals, or clinics must obtain this license.

E-Commerce Sellers

Online sellers offering medical devices through digital platforms are required to hold a valid MD-42 license, regardless of whether they operate from a physical store or warehouse.

Stockists and Exhibitors

Businesses that stock medical devices or display them at exhibitions, trade fairs, or medical expos also fall under the MD-42 licensing requirement.

Importers with Distribution Rights

Importers who distribute medical devices within India after import must also comply with MD-42 licensing norms, in addition to import-related approvals.

Note: Some non-sterile and non-measuring low-risk devices may be exempt, but professional evaluation is recommended to avoid compliance errors.

Documents Required for MD-42 License

Submitting accurate and complete documentation is essential for a smooth MD-42 license approval process.

Business and Identity Documents

• Business registration certificate (Proprietorship, Partnership, LLP, or Company)
  
  

• PAN card and GST registration
  
  

• Identity and address proof of the applicant
  
  

• Authorization letter (if applied through a consultant)
  
  

Premises-Related Documents

• Ownership proof or rent/lease agreement
  
  

• Site layout or floor plan of storage premises
  
  

• Address proof of business location
  
  

Technical and Compliance Documents

• Details of qualified technical or competent staff
  
  

• Storage condition details as per device requirements
  
  

• Standard operating procedures for handling and distribution
  
  

• Declaration of compliance with Medical Devices Rules
  
  

Application and Fee Documents

• Duly filled Form MD-41
  
  

• Government fee payment receipt
  
  

• Self-declaration and undertakings as prescribed
  
  

Ensuring document accuracy significantly reduces delays and objections during the review process.

Fee Structure and Timeline for MD-42 License

MD-42 License Fees

• The government application fee is generally ₹3,000 per premises
  
  

• Additional fees may apply for multiple locations
  
  

• Retention fees are payable periodically to keep the license active
  
  

Timeline for Approval

The approval timeline depends on document completeness and authority review:

• Application preparation and submission: 7–10 working days
  
  

• Verification and review by authorities: 3–6 weeks
  
  

• License issuance: 4–8 weeks on average
  
  

Delays often occur due to incomplete documents, incorrect declarations, or non-compliant premises, making professional assistance highly valuable.

Post-License Compliance Requirements

Once the MD-42 license is granted, businesses must continue to meet compliance obligations:

• Display the MD-42 license at the business premises
  
  

• Maintain proper records of sales, purchases, and stock
  
  

• Ensure correct storage conditions for medical devices
  
  

• Allow inspections by regulatory authorities when required
  
  

• Renew or retain the license within the prescribed timeline
  
  

Non-compliance after license issuance can lead to suspension or cancellation.

PSR Compliance Assistance for MD-42 License

Navigating medical device regulations can be complex, especially for first-time applicants or growing businesses. Professional compliance support ensures accuracy, speed, and peace of mind.

PSR Compliance provides end-to-end MD-42 license assistance, including:

• Eligibility assessment and compliance guidance
  
  

• Complete document preparation and verification
  
  

• Online application filing through the SUGAM portal
  
  

• Inspection readiness and authority coordination
  
  

• Ongoing post-license compliance support
  
  

With expert knowledge of medical device regulations and practical industry experience, PSR Compliance helps businesses obtain their MD-42 license without unnecessary delays or rejections.

🔗 For complete details and professional assistance, visit:
https://www.psrcompliance.com/md-42-license