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How do I Apply for CDSCO Registration in India?
The Following applicants can apply for online CDSCO Registration in India
Indian Agents
Corporates
Importers
Foreign Enterprises Holding Indian Subsidiary.
What are the Classifications of Forms for Existing Medical Devices?
| Applicant | Risk/Class | Type of License | Forms |
|---|---|---|---|
| Importer | A, B, C, D | Importer License | Application MD-14 Permission MD-15 |
| Manufacturer | A, B | Manufacturing License | Application MD-3 Permission MD-5 |
| Loan License | Application: MD-4 Permission: MD- 6 | ||
| C, D | Manufacturing License | Application: MD-7 Permission: MD- 9 | |
| Loan License | Application: MD-8 Permission: MD- 10 |
What are the Classifications of Forms for New Medical Devices?
| Applicant | Risk/Class | Type of License | Forms |
|---|---|---|---|
| Importer | A, B, C, D | Clinical Investigation Permission | Application MD-22 Permission MD-23 |
| A, B, C, D | Import License | Application MD-26 Permission MD-27 | |
| A, B, C, D | Test License | Application: MD-16 Permission: MD- 17 | |
| Manufacturer | A, B, C, D | Clinical Investigation Permission | Application: MD-22 Permission: MD- 23 |
| A, B, C, D | Manufacturing License | Application: MD-26 Permission: MD- 27 | |
| A, B, C, D | Test License | Application: MD-16 Permission: MD- 17 |
All about Medical Device Registration India
Medical Device Registration for Manufacturers, Medical Device Registration for Importers, Production Linked Incentive Scheme for Medical Device Manufacturers, Documentation and Inspection Services, Implementation of ISO 13485.
We help our clients in below parameters
- How to prepare all documents?
- How to get Registration Certificate?
- How to deal in all department?
Team Specialization Specification
Specialized Services under Medical Device Registration
Specialized Services under Medical Device Registration
CDSCO Services for Medical Devices
- Test License for Manufacturers
- Import License for Personal Use
- Free Sale Certificate
- Production Linked Incentive Scheme
Environmental Services for Medical Devices
- EPR for imports of Medical Devices
- EPR for Plastic Waste
- Pollution Consents to Establish and Operate
- Permission for Imports of Second Hand Equipment
IPR Services for Medical Devices
- Trademark
- Patent
- Copyright
- Integrated Circuit Layout
- IPR Registrations with Indian Customs
Other Certifications for Medical devices
- ISO Certifications for Medical Device Manufacturers
- CE Certifications for Medical Device Manufacturers
- ICMR Services for Medical Device
- BIS for Medical Device (ISI Mark)
How can ELT Corporate help you with MDR CDSCO Certification?
- We will check under which Class your product will fall, including whether your product complies with the CDSCO standards.
- Getting a CDSCO certificate is no piece of the cake, but our team at ELT Corporate will analyze the product requirements thoroughly to give clear and practical guidelines.
- We are equipped with all the essential resources to conduct a virtual pre-audit to confirm if your manufacturing unit complies with CDSCO requirements.
- You can expect reliable and punctual service delivery as we will also visit the CDSCO office on your behalf if required.Our IMDR CDSCO consultants will invest their sustained efforts to meet your queries or demands of concerned authorities.
- In case of any concern regarding the CDSCO license, we assure to provide the best possible solution concerning medical devices CDSCO registration.
- Our CDSCO consultants will coordinate with the concerned authorities for regular follow-ups.
- We at ELT Corporate, possess the required resources and team of experts to help obtain an import license for foreign or Indian manufacturers. We are well versed with the new Medical Device Rules formulated by CDSCO and provide end-to-end service and support to our clients.