Streamlined CDSCO Registration for Pharma & Medical Devices
Welcome to Rego Services Pvt. Ltd., your dedicated partner in navigating the regulatory landscape of CDSCO (Central Drugs Standard Control Organization) for pharmaceuticals and medical devices. Our tailored solutions ensure a smooth and compliant journey from consultation to market approval.
The Central Drugs Standard Control Organization (CDSCO) stands as the regulatory cornerstone for pharmaceuticals and medical devices in India. Governed by the Drugs and Cosmetics Act, 1940, CDSCO's mission is to uphold the safety, efficacy, and quality of healthcare products.
Why Choose Rego Services Pvt. Ltd.?
Rego Services Pvt. Ltd. offers expert regulatory guidance, customized solutions, and timely approvals to ensure a smooth CDSCO registration process. With end-to-end support, we assist you at every stage, from consultation to post-market surveillance.
- Expert Insight
- Tailored Solutions
- Timely Approvals
- Comprehensive Support
Our Bespoke Services
01
Carbon Footprint Measurement:
Our experienced team conducts a comprehensive assessment of your organization's carbon footprint, considering direct and indirect emissions across various scopes.
02
Seamless Registration Support:
Our adept team guides you through the intricacies of the CDSCO registration process, ensuring meticulous documentation and submission that aligns with stringent regulatory standards.
03
Product Classification Mastery:
Precise product classification is pivotal. Let us navigate the classification criteria to ensure accurate submissions and successful approvals.
04
Implementing Robust Quality Management Systems (QMS):
We assist in establishing and implementing QMS compliant with CDSCO regulations, fostering a culture of unwavering quality within your organization.
05
Labeling and Packaging Compliance Expertise:
Ensure your product labels and packaging meet CDSCO requirements with our expert guidance, creating compliant and transparent product materials.
06
Post-Market Surveillance Assurance:
Stay compliant post-registration. Our post-market surveillance services help you proactively monitor and report adverse events, ensuring continued regulatory adherence.
CDSCO Certification (Pharma/Medical Devices)
| Certification Type | Description |
|---|---|
| MD 15 Import License | Medical Device Import |
| Medical Device Registration | Registration of Medical Devices |
| MD 42 Wholesale License | Wholesale distribution of Medical Devices |
| MD 5 Manufacturer License | Class A & Class B Manufacturer License |
| MD 9 Manufacturer License | Class C & Class D Manufacturer License |
| MD 6 Loan License | License for third-party manufacturing |
Frequently asked questions
CDSCO (Central Drugs Standard Control Organization) is India’s national regulatory authority for pharmaceuticals and medical devices. Registration is mandatory to ensure the safety, efficacy, and quality of these products before they reach the market.
Manufacturers, importers, and distributors of pharmaceuticals or medical devices intending to market their products in India must obtain CDSCO registration and relevant licenses.
Required documents typically include a cover letter, product details, manufacturing license, ISO/GMP certificates, CE/BIS certificates (if applicable), and an authorization letter from the manufacturer (for importers).
The process duration may vary based on product classification and completeness of documentation, but typically it takes between 4 to 12 weeks for approval.
Yes, Rego Services Pvt. Ltd. offers post-market surveillance, labeling compliance, periodic updates, and reporting services to help maintain CDSCO regulatory adherence after registration.
