CDSCO Registration for Medical Devices & Drugs in India

Q: What is the Difference Between DCGI and CDSCO?

CDSCO (Central Drugs Standard Control Organization) is the national regulatory body for pharmaceuticals and medical devices in India. It is responsible for regulating the quality and safety of drugs, vaccines, and medical devices. The DCGI (Drugs Controller General of India) is the head of CDSCO. So, CDSCO is the organization, and DCGI is the top official leading that organization.

Q: Can I Sell Products Directly to Distributors After Registration?

Yes, once your product is successfully registered with CDSCO and you have obtained the necessary licenses, you are legally permitted to sell your products to distributors. However, ensure that your distributors also comply with any applicable licensing or storage requirements for medical devices or drugs, as per Indian regulations.

Q: What Happens if My Application Has Discrepancies or Queries?

If your application for CDSCO registration has discrepancies or queries, CDSCO will typically issue an observation letter or query. You will be given a specific timeframe to respond to these queries and provide the necessary clarifications, documents, or corrections. Failing to respond within the stipulated time or providing unsatisfactory responses may lead to the rejection of your application.

Q: What is the Typical Timeline for CDSCO Registration?

The timeline for CDSCO registration can vary significantly depending on the class of your product, the completeness of your application, and the number of queries raised by CDSCO. While there isn't a fixed timeline, Class A and B devices generally have a shorter registration period compared to Class C and D devices, which require more stringent scrutiny and potentially clinical data. It can range from a few months to over a year.

Q: Are Foreign Manufacturers Required to Have an Indian Agent for CDSCO Registration?

Yes, for foreign manufacturers, it is mandatory to appoint an authorized Indian Agent for CDSCO registration. This Indian Agent acts as a liaison between the foreign manufacturer and CDSCO, handling all regulatory submissions, communications, and compliance requirements within India. The Indian Agent is responsible for the accuracy of the submitted information and for ensuring that the foreign manufacturer complies with Indian regulations.

Q: What Documents Are Required for CDSCO Medical Device Registration?

The specific documents required for CDSCO medical device registration vary based on the device class. However, common requirements include: Application form (MD-14 or MD-15). The manufacturer's ISO 13485 certification. Free Sale Certificate (FSC) or Certificate of Pharmaceutical Product (CPP) from the country of origin. Device Master File (DMF) detailing product information, manufacturing process, and quality control. Plant Master File (PMF) describing the manufacturing facility. Clinical data (for higher-risk devices). Stability data. Labeling and IFU (Instructions for Use). Undertakings and declarations. Power of Attorney for the Indian Agent.

Q: Do I need a separate CDSCO registration for cosmetics?

Yes, a separate CDSCO registration is required for cosmetics. If you are planning to import or sell cosmetic products in India, you must obtain a specific registration certificate for each product category as per the regulations laid out by CDSCO. This registration is distinct from the one required for drugs or medical devices.

Q: Why should I hire a consultant for my CDSCO registration?

Hiring a consultant for your CDSCO registration can make the entire process much smoother. The registration procedure involves complex documentation, regulatory compliance, and frequent coordination with government authorities. A consultant can guide you through the correct process, help avoid mistakes that lead to delays, and ensure timely approvals. Their expertise can save you both time and effort while ensuring that all requirements are met efficiently.

Get CDSCO registration for your medical devices or drugs with RegisterKaro. Ensure regulatory compliance and fast-track approvals through our reliable, expert-led service. What you get:

CDSCO Portal Registration for Drugs & Devices

Classification Assistance as per CDSCO Guidelines

Complete Support for Importers & Manufacturers

Expert Help with CDSCO Forms & Fees

Seamless CDSCO License & Certificate Process

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Serving Businesses Across India

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Frequently Asked Questions (FAQs)

Which Class Will My Product Fall Under?

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The classification of medical devices in India, as per CDSCO, is based on the risk associated with their use. Products are categorized into four classes: Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk), and Class D (high risk). The classification determines the regulatory pathway and requirements for registration. You will need to refer to the Medical Device Rules, 2017, and subsequent amendments, or consult with a regulatory expert to accurately determine your product's class.

What is the Difference Between DCGI and CDSCO?

Can I Sell Products Directly to Distributors After Registration?

What Happens if My Application Has Discrepancies or Queries?

What is the Typical Timeline for CDSCO Registration?

Are Foreign Manufacturers Required to Have an Indian Agent for CDSCO Registration?

What Documents Are Required for CDSCO Medical Device Registration?

Do I need a separate CDSCO registration for cosmetics?

Why should I hire a consultant for my CDSCO registration?

Why Choose RegisterKaro for the CDSCO Registration Service?

Getting CDSCO registration can be confusing and take a lot of time. But with RegisterKaro’s help, the process becomes much easier. Our team knows the rules well and will guide you at every step to make sure everything is done correctly and on time.

Our Expertise and Experience: Leverage a team with in-depth knowledge of CDSCO regulations and years of experience navigating the complexities of product registration.
Simplifying the Entire Process: We streamline the often intricate and time-consuming CDSCO registration journey, managing documentation, submissions, and follow-ups.
Saving Time and Money: Avoid common pitfalls and delays, get your products to market faster, and minimize lost opportunities and costs.
Specialization in BIS Conversion: Benefit from our particular expertise in converting existing BIS certifications or aligning products with both BIS and CDSCO requirements.

Why Choose RegisterKaro for the CDSCO Registration Service?

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