The Central Drug Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices. The CDSCO is responsible for the approval and regulation of New Drugs and Clinical Trials in the Country, laying down the standards for Drugs, control over the quality of imported drugs, coordination of the activity of State Drug Control Organizations. Under the new dispensation, foreign manufacturers have to apply for a registration certificate for their manufacturing premises and the individual drugs to be imported.
The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority of India, and the Director-General of Health in India controls CDSCO. Since 2016, they have implemented new drug and clinical trial regulations and guidelines.
All medical devices entering India must comply with the Indian Medical Device Regulation set forth by the Central Drugs Standard Control Organization (CDSCO). All manufacturers, importers, and distributors must register their medical devices and obtain an import license from CDSCO. The CDSCO Import License also relies on other factors outside of the device itself, including the manufacturer’s location, manufacturing standards, and the quality and safety standards of the factory. CDSCO Import License of medical devices is mandatory for any industry or an individual who plans to import medical devices in India. CDSCO Import license of medical devices is regulated in India. Any industry or individual with a license (wholesale and manufacturing license issued under central drug standard control organization (CDSCO), Drugs and cosmetics act, 1940 can import medical devices into India. A foreign manufacturer exporting to India must obtain an Import License through a registered importer dealing with the products. The import license granted under Drugs and Cosmetics Rules, 1945 reflects that the imported products conform to set standards through testing. The CDSCO also provides a Certificate of import license for all therapeutic goods such as pharmaceuticals for human use, biological, blood and blood components, Medical devices, diagnostic kits etc. The CDSCO is authorized to Approve, Prohibit, and Monitor Clinical Trials on Medical Devices in India. The regulation aims to balance the benefits and risks of medical devices and arrive at an evidence-based approach. CDSCO module to register and license Manufacturers, Wholesalers, Testing Laboratories and Other related applications like renewal, temporary permits, amendment etc. The Drugs and Cosmetics Act and Rules discharge all functions to specific categories of new drugs. The Licensing Authority shall grant the import licenses after considering the recommendations of the Import Licensing committee, which is held responsible for reviewing applications relating to import license and fixation of required norms.
We help you import medical devices from all over the world. Our services include:
- Obtain the manufacturing and local commercial registration – CDSCO Import License and MSME License.
- Obtain Drug Master File (DMF).
- Obtain Certificate of Free Sale, GMP Certification for your plant, the appointment of a local agent and representative to represent you in India.
- Prepare the product dossier for registration and renewals.
- Label evaluation for compliance with Indian labelling requirements.
If you want to launch your product in India, you need to know importation procedures and requirements. To help you understand the process, we have created this guide on importing medical devices in India.
CDSCO Import of medical devices in India Requirements:
- Form41 (Registration Certificate) is required as per requirements of the Drugs & Cosmetic Act.
- Wholesale Drug License in Form 20B & 21B.
- The firm must be registered with the CDSCO Sugam Online System.
Process for Obtaining CDSCO Import License:
For Obtaining an Import License in Form 10, an application in Form 8 and Form 9 is required. Since 1 April 2016, All Applications Should be made through the CDSCO’s Sugam Portal. For more information on the CDSCO’s – Portal for CDSCO Import License and Registration Certificate.
The Different purposes for which an applicant can register under the CDSCO portal are:
- Cosmetics Registration.
- Import or Manufacture of drugs.
- Export NOC (Zone).
- Test License.
- Ethics Committee Registration.
- Formulation R&D Organization.
- Blood Bank Registration.
- Blood Product Registration.
- Dual Use NOC (Trader).
- BA/BE Approved Sites.
- Sponsors (BA/BE and CT).
Important license and forms for CDSCO:
- Medical Device Registration Certification.
- Import Authorization.
- Import Test License.
- Manufacturing Test License.
- Approval for a clinical trial.
- Market approval following a successful clinical trial.
- Permission to produce following the completion of a satisfactory clinical trial.
- Retail sale of a notified medical device.
- Wholesale sale of a notified medical device.
- Manufacturing license for a notified medical device.
- License to lend (manufactured in facility owned by third party).
Document required CDSCO License:
- Id proof.
- Rent agreement/ownership proof.
- Undertaking issued by a government authority.
- Manufacturing license or wholesale License in case of import.
- Copy of Approved CDSCO.
- Form 40.
- IEC code.
CDSCO registration with an export and Import license is mandatory for all medical products such as pharmaceuticals, including diabetic drug manufacturers, registered medical device distributors, wholesalers, and manufacturers.
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