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 (Central Drugs Standard Control Organization) is the regulatory body for all aspects of Medical Devices, drugs & cosmetics in India. CDSCO needs to Register Importers, Manufacturers and Wholesalers; therefore, if you are currently an importer, manufacturer or wholesaler of drugs in India and would like to import drugs into India, these instructions will guide you through the process. It’s responsible for importing, manufacturing and selling drugs. Medical Devices Testing India can help you get your products cleared by the Indian government. According to the Drugs and Cosmetics Act 1940, CDSCO provides the legal framework for regulating India’s manufacture, sale and distribution of medicines. The Medical Device Manufacturers/ Importers who wish to sell their products in India must obtain a Registration Certificate from the Central Drug Research Institute (CDRI) & CDSCO for its clearance before the import of medical devices can be done. Such products include Dental Instruments, Hearing Aids and Sterilizers, among many others. We can provide all the legal and technical guidelines for importing and exporting cosmetic products with full support to improve your business.
Relaxation to obtain CDSCO Medical Device Certification:
- The government has given time to the medical device industry to transition into the regulatory framework and to obtain ISO 13485 certification, if not already obtained.
- The government has relaxed the requirement to obtain registration and license for Newly Notified Medical Devices for the following period.
|Class of medical device||Licensing Authority||Stipulated timeline for processing application||Deadline for obtaining license|
|Class A and B (imported or manufactured)||State-level Licensing Authority||Up to 3 months (estimated)||September 30, 2022|
|Class C and D (imported or manufactured)||State-level Licensing Authority||Up to 3 months (estimated)||September 30, 2023|
The following, Import for CDSCO Medical Devices Rules:
- Registration will be required to import or manufacture such medical devices, but no license will be required.
- 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.
- License will be required to manufacture, import, distribute or sell Class C and Class D medical devices as well.
Drugs Import & Registration:
- The import of Drugs into India is regulated under Chapter III of Drugs & Cosmetics Act & Part IV of Drugs & Cosmetics Rules.
- 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:
- New Drugs.
- Import & Registration.
- Clinical Trials.
- Medical Device & Diagnostics.
The Rules 122A, 122B, 122 DAB, 122DAC, 122 DD and 122E of Drugs & Cosmetics Rules give the information, data required for approval of clinical trial and or to import or manufacture of newly introduced drug for marketing in the
Documents Required for CDSCO Certification:
- Form 40
- ISO 13485 certificate
- Full Quality Assurance Certificate
- CE Design Certificate
- Undertaking that all information provided is authentic
- Either a Free Sale Certificate or Certificate from the Foreign Government
- Certificate of Marketability from GHTF (Australia, Canada, Japan, the European Union, and the United States);
- Plant Master Report
- Device Master File