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 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.
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