CDSCO Class A Medical Devices Registration

Our Services

CDSCO Class A Medical Devices Registration

Simplify the approval process for low-risk medical devices with our expert assistance. We help you prepare documentation, ensure compliance with CDSCO guidelines, and obtain your Class A Medical Devices License, both import licenses and manufacturing licenses smoothly and efficiently.

At Zensen, we simplify the entire process, ensuring your application is accurate, complete, and compliant with the latest regulatory standards.

Why Choose Zensen?

  • Deep expertise in CDSCO regulations

  • Faster turnaround time for approvals

  • Dedicated support for Class A medical devices

  • Transparent process and continuous updates

Secure your Class A Medical Device License with confidence and focus on growing your business — while we handle the compliance.

CDSCO Medical Devices for Class A

At Zensen, we simplify the entire process, ensuring your application is accurate, complete, and compliant with the latest regulatory standards.

Our Services Include:

Regulatory Consultation
Understanding the requirements specific to your device category and helping you navigate CDSCO guidelines.

Documentation Support
We assist in preparing and reviewing all mandatory documents, including technical files, device master records, and quality management system details.

Application Filing
End-to-end support in submitting your application to the appropriate licensing authority for Class A devices.

Post-Approval Support
Guidance on maintaining compliance, renewals, and addressing any regulatory updates affecting your license.

MD-42 Documentation

MD-42 is a crucial license for manufacturers of Class A and Class B medical devices in India. It is mandatory for ensuring that your manufacturing processes meet regulatory quality and safety standards as per CDSCO guidelines.

At Zensen, we streamline the MD-42 licensing process to help you achieve compliance without stress.

Our Services Include:

Eligibility Assessment & Guidance
We help you understand if your products fall under MD-42 and prepare accordingly.

Documentation Preparation
Complete assistance in compiling technical documents, quality manuals, site master files, and device master records.

Application Submission
We handle the submission of your application with precision and accuracy.

Wholesale and retail Licence Documentation

Whether you are looking to open a medical store or start wholesale distribution of pharmaceuticals, obtaining the appropriate drug license is a legal necessity.

Zensen provides end-to-end support to help you acquire both Wholesale and Retail Drug Licenses efficiently.

Our Services Include:

Eligibility Evaluation
Assessing your business requirements to determine the right license type.

Documentation Assistance
Preparation of essential documents including premises proof, pharmacist qualifications, and business registration details.

Application Filing & Follow-Up
Complete application preparation and proactive follow-up with Drug Control Authorities.

Inspection Preparation
Guidance on site readiness and compliance checks for inspection.

Post-License Support
Assistance with renewals, modifications, and regulatory compliance.

MSME Registration

Registering as a Micro, Small, or Medium Enterprise (MSME) opens doors to numerous government benefits, subsidies, and financial support schemes.

Zensen offers a seamless MSME registration process to help your business thrive.

Our Services Include:

Eligibility Check
Determine if your business qualifies as Micro, Small, or Medium.

Document Preparation
Assistance in preparing business PAN, Aadhaar, and other required documents.

Application Filing
Fast and accurate submission of your MSME registration application.

Certificate Issuance Support
We follow up until you receive your official MSME certificate.

Post-Registration Benefits Guidance
Informing you about subsidies, bank loans, and schemes you can avail.

Trade mark registration for Medical Devices

Trademark Registration

Your brand name is your identity — and protecting it is critical. Trademark registration ensures your brand remains legally protected from misuse or infringement.

At Zensen, we make trademark registration simple and stress-free.

Our Services Include:

Trademark Search & Analysis
Ensure your brand name/logo is unique and available for registration.

Documentation & Application Filing
Complete preparation and submission of your trademark application.

Response to Objections (if any)
Expert handling of examination reports and oppositions.

Status Monitoring & Updates
We keep you updated through every stage of the process.

Trademark Renewal Services
Assistance with timely renewals to maintain your protection.

Impoer Export Certificate for Medical Devices

Planning to expand your business globally? An Import Export Code (IEC) is mandatory for businesses involved in international trade.

With Zensen, obtaining your IEC certificate is fast, simple, and hassle-free.

Our Services Include:

Eligibility Assessment
We confirm if your business requires an IEC based on your trade goals.

Documentation Support
Preparation of PAN, identity proofs, bank details, and business documents.

Application Submission
We file your IEC application accurately and promptly.

Regular Updates
Tracking your application status and providing timely updates.

Post-Issuance Support
Guidance on how to use your IEC and comply with foreign trade policies.

Talk to us

Have any questions? We are always open to talk about your business, new projects, creative opportunities and how we can help you.

+91 9600 521 721

info@zensenventures.in

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