CDSCO Medical Device Registration Services

Streamlining Compliance for Medical Device Manufacturers and Importers Worldwide

The healthcare industry, especially the medical device sector, is one of the most regulated industries, ensuring the safety and efficacy of devices for public health. In this context, the Central Drugs Standard Control Organization (CDSCO) plays a critical role as the national regulatory authority responsible for regulating medical devices. Any medical device manufacturer, importer or distributor aiming to bring products to the market must obtain CDSCO Medical Device Registration.

At Ornate Quality Services Pvt. Ltd., we provide comprehensive CDSCO Medical Device Registration services, assisting businesses in navigating the complex regulatory landscape and ensuring smooth entry into the market.

What is CDSCO Medical Device Registration?

CDSCO, governed by the Ministry of Health and Family Welfare, is the regulatory authority responsible for overseeing the safety, quality and performance of medical devices. Registration with CDSCO is mandatory for all manufacturers and importers of regulated medical devices to ensure compliance with the Medical Devices Rules, 2017.

CDSCO Medical Device Registration certifies that the device meets the required safety and performance standards, making it eligible for sale and distribution. Whether you're a domestic manufacturer or a global exporter, complying with these regulations is essential for market access and credibility.

Our CDSCO Medical Device Registration Services

At Ornate Quality Services Pvt. Ltd., we offer end-to-end support for obtaining CDSCO Medical Device Registration. From documentation preparation to regulatory submissions, our services ensure that your registration process is seamless and efficient.

Key Services We Offer

1. Product Classification and Eligibility Assessment
We assess your medical devices to determine their classification (Class A, B, C or D) as per CDSCO guidelines and identify whether they fall under the notified medical device category requiring registration.

2. Documentation Preparation and Review
Our experts assist in preparing all necessary documents with precision, ensuring compliance with CDSCO requirements, including:

• Application Form MD-14 or MD-15
• Device Master File (DMF)
• Technical documentation
• ISO 13485 certificate
• Free Sale Certificate (FSC) for imported devices
• Clinical evaluation reports (if applicable)

3. Device Testing and Standards Compliance
We ensure that your device complies with the applicable national and international standards, facilitating testing and evaluation where required.

4. Authorized Indian Agent Support for Foreign Manufacturers
For foreign manufacturers, we act as the Authorized Indian Agent (AIA) to represent your interests and facilitate the registration process with CDSCO.

5. Application Submission and Liaison with CDSCO
We handle the submission of your application to CDSCO and act as your liaison, addressing queries, providing additional documentation and ensuring timely updates.

6. Post-Registration Support
After obtaining registration, we offer ongoing compliance management, including renewal services, amendments and support for any regulatory audits or inspections.

Why Choose Ornate Quality Services Pvt. Ltd.?

1. Expert Knowledge of Regulatory Requirements
   With our deep understanding of CDSCO guidelines, we ensure 100% compliance for your medical device registration process.
2. Comprehensive Documentation Assistance
   Our team simplifies the intricate documentation process, reducing the chances of application rejection or delays.
3. Global Perspective
   We provide services to both domestic and international manufacturers, ensuring seamless entry into regulated markets.
4. Dedicated Support Team
   Our dedicated professionals guide you through every step of the registration process, offering end-to-end support and personalized assistance.
5. Timely and Efficient Process
   We prioritize efficiency and accuracy to ensure your device registration is completed in the shortest possible timeframe.

Benefits of CDSCO Medical Device Registration

• Legal Market Access:
  Obtain the necessary approvals to legally sell and distribute your devices.
• Enhanced Credibility:
  Registration demonstrates compliance with stringent regulatory standards, building trust among healthcare professionals and consumers.
• Global Recognition:
  CDSCO registration ensures your device is aligned with international quality and safety standards, enhancing global market opportunities.
• Risk Mitigation:
  Registration ensures that your device complies with safety regulations, minimizing the risk of legal or financial liabilities.

Documents Required for CDSCO Medical Device Registration

To simplify your registration process, our team ensures that all required documents are prepared and submitted correctly. Key documents include:

• Covering letter
• Application form (MD-14 or MD-15)
• Device Master File (DMF)
• Plant Master File (PMF)
• ISO 13485 certificate
• Free Sale Certificate (FSC) for imports
• Clinical investigation reports (if required)
• Performance evaluation data

Streamline Your Medical Device Registration with Ornate Quality Services

Obtaining CDSCO Medical Device Registration is essential for bringing your products to market and ensuring their compliance with regulatory requirements. Ornate Quality Services Pvt. Ltd. is your trusted partner for seamless and efficient registration services.

Our team of experts ensures that your application meets all CDSCO guidelines, minimizing the risk of delays or rejections. Whether you're a manufacturer, importer or distributor, we simplify the registration process, enabling you to focus on your core business operations.

Contact Us Today
Let Ornate Quality Services Pvt. Ltd. handle the complexities of CDSCO Medical Device Registration, so you can bring your innovative medical devices to the market confidently.

• Call/WhatsApp: +91-9266333338, +91-8800013897
• Email: marketing@ornatequality.com, chetan@ornatequality.com