PSR Compliance

Expert Guidance for CDSCO Registration & Compliance

PSR Compliance provides end-to-end consultancy services for CDSCO (Central Drugs Standard Control Organization) registration and compliance across India. We assist pharmaceutical, medical device, and cosmetic manufacturers in obtaining the necessary approvals, ensuring smooth market entry and regulatory adherence.

✔ CDSCO Registration – Assistance in obtaining approvals for drugs, medical devices, cosmetics, and biologicals.
✔ Import & Manufacturing License – Guidance on licensing requirements for importers and manufacturers.
✔ Regulatory Compliance – Ensuring adherence to Drugs & Cosmetics Act, 1940, and CDSCO guidelines.
✔ Application & Documentation Support – End-to-end assistance in preparing and submitting applications.
✔ Liaison with CDSCO Authorities – Coordination with regulatory bodies for approvals and follow-ups.
✔ Post-Approval Compliance – Assistance with periodic filings, audits, and renewals.

✅ Expert Regulatory Consultants
✅ Pan India Support
✅ Hassle-Free Documentation & Filing
✅ Quick Processing & Approval Assistance

Ensure smooth and compliant product approvals with PSR Compliance – Your Trusted CDSCO Consultant!

We are engaged in offering a qualitative Medical Device Manufacturing License Service to our valuable clients. We offer this service in an excellent manner within a scheduled time-frame. The offered service is performed by our highly qualified professionals using excellent grade tools and advanced technology. Owing to its perfect execution and flawlessness, this service is widely appreciated by our precious clients. Further, we provide this service as per the requirements of our clients at most affordable price.

At PSR Compliance we are providing an excellent quality CDSCO Medical Device Import License .The provided service is carried out under the supervision of our experts using optimum grade machines and modern technology. This service is performed as per the requirements of our valuable clients within the scheduled time-frame. The offered service is highly acknowledged by our clients owing to its high reliability and cost effectiveness features. Further, the provided service is performed as per the clients’ specific needs with respect to their budgetary constraints.

Being a prominent firm in this domain, we are engaged in offering Medical Device Registration Services.Offered service is performed under the strict supervision of our experts using optimum grade tools and latest technology. Our professionals perform this service as per the requirements of our clients. Moreover, this service can be availed by our clients at most reasonable price.

We are the leading organization to offer our precious clients an optimum quality Cosmetics Import License Service. This service is carried out under the strict supervision of our experts using the best grade tools and advanced techniques. Our skilled professionals ensure the clients that the service, provided by us is highly reliable and executed in an excellent manner. The offered service is performed within a stipulated time-frame. Furthermore, this service can be availed by our precious clients at budget-friendly prices.

PSR Compliance: Comprehensive Medical Device Import Licensing Services Across India
Navigating the complexities of importing medical devices into India requires specialized knowledge and adherence to stringent regulatory standards. PSR Compliance offers expert consultancy services to streamline the process, ensuring full compliance with the Central Drugs Standard Control Organization (CDSCO) guidelines.
Our Comprehensive Services Include:

Regulatory Consultation: We provide in-depth guidance on the regulatory requirements for importing medical devices into India, ensuring your business aligns with the latest CDSCO standards.

Documentation Assistance: Our team assists in the meticulous preparation and submission of all necessary documents, including the Plant Master File and Device Master File, as per the Medical Device Rules, 2017.

Authorized Representation: For foreign manufacturers, we act as the Indian Authorized Agent, facilitating seamless communication with regulatory authorities and ensuring compliance throughout the importation process.

Import License Application: We manage the entire application process for obtaining the Import License (Form MD-15), from initial submission to final approval, minimizing delays and ensuring accuracy.

Post-Licensing Support: Our services extend beyond licensing, offering ongoing support to ensure continuous compliance, including assistance with renewals, audits, and any necessary updates to your licensing status.

Why Choose PSR Compliance?

Expertise: Our team comprises professionals with extensive experience in medical device regulations, ensuring informed guidance tailored to your specific needs.

Nationwide Service: We offer our services across India, providing consistent support regardless of your location.

Customized Solutions: Understanding that each client has unique requirements, we offer personalized strategies to efficiently navigate the regulatory landscape.

Timely Execution: We prioritize prompt service delivery, recognizing the importance of time in bringing medical devices to market.

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Partner with PSR Compliance to ensure a seamless and compliant process for importing medical devices into India, allowing you to focus on delivering quality healthcare solutions.

PSR Compliance offers expert consulting for obtaining CDSCO Manufacturing Licenses for medical devices in India under the Medical Device Rules, 2017. We support manufacturers in documentation, application filing, and end-to-end regulatory approvals.

• Form MD-5 – License to manufacture Class A & B medical devices.

• Form MD-9 – License to manufacture Class C & D medical devices.

• Form MD-7 – Loan license for Class A & B medical devices.

• Form MD-11 – Loan license for Class C & D medical devices.

• Guidance on classification of medical devices (Class A, B, C, D).

• Preparation of technical documents & plant master file (PMF).

• Filing applications on CDSCO SUGAM Portal.

• Liaison with CDSCO / State Licensing Authority.

• Support in audit & compliance until final license grant.

• Specialized in Medical Device Licensing.

• Experienced team handling Class A to D applications.

• Accurate documentation, faster approvals.

• PAN India support for manufacturers.

Medical Device Registration in India is the regulatory process that manufacturers and importers of medical devices must undergo to market and sell their products within the country. It is governed by the Central Drugs Standard Control Organization (CDSCO), which is part of the Ministry of Health and Family Welfare. The registration process involves submitting detailed information about the medical device, including its specifications, quality, safety, and intended use, along with data from clinical trials if required. CDSCO assesses this information to ensure that the device complies with Indian regulatory standards, is safe for use, and performs as claimed. Once approved, the device is granted a registration certificate, allowing it to be legally distributed and sold in the Indian market. Registration is a crucial step to ensure that medical devices meet the necessary quality and safety standards, safeguarding the health and well-being of patients and users.