CDSCO Registration is the process of getting approved by the Central Drugs Standard Control Organization (CDSCO) in India. CDSCO is the top body for checking the safety and quality of drugs and medical devices. It works under the Ministry of Health and Family Welfare.
Testing Equipments
Testing Reports
Certification Served
following can apply for CDSCO Certification in India:
1. Drug Manufacturers and Importers
Companies making or importing drugs and active ingredients.
2. Medical Device Manufacturers and Importers
Manufacturers, Importers and Companies handling Class A, B, C, or D of medical devices and equipment.
3. Cosmetic Manufacturers and Importers
Companies making cosmetic products like skincare and haircare, Importers of foreign cosmetic brands. And Entities wanting to sell products under the Drugs and Cosmetics Act.
4. Biopharmaceutical and Biologics Companies
Companies making biologics like vaccines and blood products. and Biopharma companies involved in the research and development of biological therapies.
5. Diagnostic Kit Manufacturers and Importers
Companies making or importing diagnostic kits like blood tests and COVID-19 test kits. and Entities making laboratory reagents and devices for disease detection.
6. Contract Research Organizations (CROs)
Organizations doing clinical trials or research studies for manufacturers or importers.
7. Pharmaceutical Distributors and Wholesalers
Distributors and wholesalers needing CDSCO approval for certain products.
8. Importers of New Drugs and Investigational Products
Companies importing new drugs or investigational drugs for trials or limited use in India.
1. Application Form
2. Cover Letter
3. Product Information (Product Label and Artwork, Technical Specification Sheet, Test Reports)
4. Manufacturing Documents (Manufacturing License, Good Manufacturing Practice (GMP), Free Sale Certificate For importers)
5. Power of Attorney
6. Clinical Evaluation Reports (If Applicable)
7. Device Master File (For Medical Devices) (Manufacturing processes, Design specifications, Risk analysis, Packaging and labelling)
8. Plant Master File (For Medical Devices)
9. Product Dossier (For Pharmaceuticals) (Drug composition/formulation, Stability studies, Method of manufacturing, Test procedures, Drug master file (if applicable)
10. Import-Export Code (IEC)
11. Authorization Letter (For Importers)
12. Certificate of Analysis
13. Undertaking/Declaration
14. Additional Documents- Drugs (Drug Master File, Clinical Trial Approvals), Medical Devices (Risk Management Plan, ISO 13485 Certificate) Cosmetics (Ingredient List, Safety and Toxicology Reports).
Step 1: Determine Eligibility and Requirements
We identify the type of registration needed (drugs, medical devices, cosmetics, etc.). and also Review the specific requirements for your product category, including necessary documents and application forms.
Step 2: Gather Required Documents
Our Certification experts help you to Compile all necessary documents to ensure that all documents are accurate, complete, and in the required format.
Step 3: Submitting the application form and Payment of Registration Fees
After we have all the necessary documents we submit the application form on the portal and make the payment of application fees.
Step 4: Application Review by CDSCO
Post the Submission, The CDSCO will review the submitted application and documents.
Step 5: Inspection (if applicable)
For certain products, the CDSCO may conduct an inspection of the manufacturing facility to verify compliance with regulatory standards.
Step 6: Issuance of Registration Certificate
CDSCO regulates a wide range of products to ensure their safety, efficacy, and quality
CDSCO registration covers products such as Drugs and Pharmaceuticals, Medical Devices:, Cosmetics and In-vitro Diagnostics (IVD) etc.
1. Drugs and Pharmaceuticals
Drugs and Pharmaceuticals like Prescription Drugs, Over-the-Counter (OTC) Drugs, Biopharmaceuticals, Active Pharmaceutical Ingredients (APIs).
2. Medical Devices
Medical Devices such as Class A, B, C & D Devices
3. Cosmetics
Cosmetics like Skincare Products, Hair Care Products, Makeup Products, Perfumes and Fragrances.
4. Biologics
Biologics such as Vaccines, Blood Products, Cell and Gene Therapies
5. Diagnostic Kits
Biologics such as Vaccines, Blood Products, Cell and Gene Therapies
6. Herbal and Ayurvedic Products
Herbal and Ayurvedic Products such as Traditional Medicines
The time it takes to get CDSCO registration can change. It depends on the product type, how complete the application is, and the regulatory workload. Instacertify can make the application process easier. They help prepare documents and answer CDSCO questions quickly, which can speed up the process.
We've worked with several certification companies in the past, but none compare to Insta Certify Services. Their streamlined testing and certification processes have saved us time and resources. The team goes above and beyond to ensure everything is done correctly, and their equipment is cutting-edge.
We've worked with several certification companies in the past, but none compare to Insta Certify Services. Their streamlined testing and certification processes have saved us time and resources. The team goes above and beyond to ensure everything is done correctly, and their equipment is cutting-edge.
We've worked with several certification companies in the past, but none compare to Insta Certify Services. Their streamlined testing and certification processes have saved us time and resources. The team goes above and beyond to ensure everything is done correctly, and their equipment is cutting-edge.
We've worked with several certification companies in the past, but none compare to Insta Certify Services. Their streamlined testing and certification processes have saved us time and resources. The team goes above and beyond to ensure everything is done correctly, and their equipment is cutting-edge.
Not always. But, high-risk products might need an inspection. CDSCO decides this during the review.
If rejected, CDSCO will explain why. You can fix the issues and apply again.
CDSCO registrations last five years. Then, you need to renew your application.
Yes, you can apply for CDSCO (Central Drugs Standard Control Organization) registration online on behalf of a consulting firm to avoid complications.
The process can take 4 to 8 weeks. It depends on the product’s complexity and how fast responds to CDSCO’s queries.
Manufacturers, importers, and distributors of drugs, medical devices, and cosmetics must register their products with CDSCO before marketing them in India.
