CDSCO Medical Devices Registration in India

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The Central Drugs Standard Control Organization (CDSCO) provides you with simple instructions on applying for Registration and Import Approval of Drugs, Cosmetics and Medical Devices in India.

The Central Drugs Standard Control Organization (CDSCO) provides you with simple instructions on applying for Registration and Import Approval of Drugs, Cosmetics and Medical Devices in India. CDSCO Registration of Importers, Manufacturers and Wholesalers of Drugs and Cosmetics in India allows you to import raw materials, intermediate finished goods, or both into the country. The CDSCO is the regulatory body for all aspects of India's medical devices, drugs, and cosmetics. CDSCO is responsible for the clinical evaluation, registration and safety of medical devices, drugs cosmetics in India. We help you get the required certificates from CDRI CDSCO (Central Drugs Standard Control Organization) for importing drugs and medical devices. Here are some of the standard Medical Devices that might require registration: Medical appliances, Clinical equipment, Blood/ Blood products, Diagnostic kits/ instruments, Medical consumables and other Medical Products. It is mandatory to get your manufacturing units approved by CDSCO before importing medical equipment in India.

The following, Import for CDSCO Rules:

  1. Registration will be required to import or manufacture such medical devices, but no license will be required.
  2. License will be required to manufacture, import, distribute or sell Class A or Class B medical devices, but no license will be required to manufacture, import, distribute or sell Class C or Class D medical devices.
  3. License will be required to manufacture, import, distribute or sell Class C and Class D medical devices as well.

Drugs Import Registration:                               

  1. The import of Drugs into India is regulated under Chapter III of Drugs Cosmetics Act Part IV of Drugs Cosmetics Rules.
  2. The applications for registration certificate import license of drugs are processed as per the Drugs Cosmetics Rules.

Rules Governing Clinical Trials:

Rule 122-A: Registration for permission to import new drug.

Rule 122-B: Registration for approval to manufacture new drug.

Rule 122-DA: Necessary requirement of permission from DCG for conduct of clinical trial of new drug;

Rule 122 DAB: Provision for compensation during a clinical trial related case. Provision for cancelling of the license of the applicant in case of failure to pay compensation

Rule 122 DAC: Requirement of permission for conduct of clinical trial which includes necessary requirement to follow Good Clinical Practice (GCP) guidelines, guidelines and requirements given in Schedule Y of Drugs and Cosmetics Rules. Provision for cancellation of license of applicant and investigator in case of failing to do compliance.

Rule 122 E: Definition of new drug.

Schedule Y: Detailed instruction and essential details for the procedure to conduct clinical trial and approval of new drug.

Good Clinical Practice Guidelines -Issued by Central Drug Standard Control Organization and Directorate General of Health Services, Govt. of India.

Following are the list of CDSCO Certification for Drug Import:

  1. New Drugs.
  2. BA/BE.
  3. Import Registration.
  4. Biological
  5. Cosmetics
  6. Clinical Trials.
  7. Medical Device Diagnostics.
  8. DCC-DTAB.

Documents Required for CDSCO Certification:

  1. Form 40
  2. ISO 13485 certificate
  3. Full Quality Assurance Certificate
  4. CE Design Certificate
  5. Undertaking that all information provided is authentic
  6. Either a Free Sale Certificate or Certificate from the Foreign Government 
  7. Certificate of Marketability from GHTF (Australia, Canada, Japan, the European Union, and the United States);
  8. Plant Master Report
  9. Device Master File
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