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India Authorized In Country Agent and Importer for Medical Devices
Medical Devices and In Vitro Diagnostics (IVDs) in India are regulated by the Central Drug Standard Control Organization (CDSCO) under the Medical Device Rules, 2017, effective since January 1, 2018. Initially, only 37 medical devices were regulated under MD-14, but now all medical devices and IVDs must be classified and obtain an MD-15
Importer License via an Importer or Authorized Agent as Class A, B, C, or D to be sold in the Indian market. For Class C and Class D Medical Devices and IVDs not included in the original list of 37 regulated products, the CDSCO has extended the licensing compliance deadline to September 30, 2023.
Medical Devices and In Vitro Diagnostics (IVDs) in India are regulated by the Central Drug Standard Control Organization (CDSCO) under the Medical Device Rules, 2017, effective since January 1, 2018. Initially, only 37 medical devices were regulated under MD-14, but now all medical devices and IVDs must be classified and obtain an MD-15
Importer License via an Importer or Authorized Agent as Class A, B, C, or D to be sold in the Indian market. For Class C and Class D Medical Devices and IVDs not included in the original list of 37 regulated products, the CDSCO has extended the licensing compliance deadline to September 30, 2023.
Applying for MD-14 via Morulaa as your India Importer or Authorized Agent means you can work with Multiple Distributors, Protect Sensitive Information from Channel Partners on your Certificates, Device Technical File & Manufacturing, Remain Compliant Post Approval to minimize Supply chain Disruptions, Maintain your independence at minimal cost via Morulaa as your representative
The MD-15 Import License by CDSCO requires any manufacturer supplying their Medical Devices IVDs into India to have a local authorized representative with registration on the SUGAM portal and to act as a liaison for all communication with the authorities.
Applying for MD-14 via Morulaa as your India Importer or Authorized Agent means you can work with Multiple Distributors, Protect Sensitive Information from Channel Partners on your Certificates, Device Technical File & Manufacturing, Remain Compliant Post Approval to minimize Supply chain Disruptions, Maintain your independence at minimal cost via Morulaa as your representative
The MD-15 Import License by CDSCO requires any manufacturer supplying their Medical Devices IVDs into India to have a local authorized representative with registration on the SUGAM portal and to act as a liaison for all communication with the authorities.
As your Representative, help you determine whether changes to the manufacturing process or device are reportable to the CDSCO. If reportable, assist in preparing the necessary certificates and documents.
As your Importer or Authorized Agent, Morulaa would liaison with the CDSCO post-approval certificates for any necessary communication.
Cooperate with authorities on CAPA to eliminate risks posed by medical devices and inform the manufacturer about compliances or reports received from authorities, healthcare professionals, patients, or users are some activities we do as your representative
As your Importer or Authorized Agent, Morulaa helps you remain compliant during the 5-year validity of the MD-15 registration certificate to ensure an easier and faster renewal process.
Post Market Surveillance, Adverse Event Reporting, Recalls, and other necessary post-market activities are supported in India by Morulaa as your Importer or Authorized Agent
As your Importer or Authorized Agent, Morulaa would liaison with the CDSCO post-approval certificates for any necessary communication.
As your Representative, help you determine whether changes to the manufacturing process or device are reportable to the CDSCO. If reportable, assist in preparing the necessary certificates and documents.
Cooperate with authorities on CAPA to eliminate risks posed by medical devices and inform the manufacturer about compliances or reports received from authorities, healthcare professionals, patients, or users are some activities we do as your representative
As your Importer or Authorized Agent, Morulaa helps you remain compliant during the 5-year validity of the MD-15 registration certificate to ensure an easier and faster renewal process.
Post Market Surveillance, Adverse Event Reporting, Recalls, and other necessary post-market activities are supported in India by Morulaa as your Importer or Authorized Agent
Ensure that all medical devices and IVDs being sold in India have India importer-specific labeling, verifying and adding labels as required by the CDSCO.
Determine the duty structure and taxes applicable to your devices.
Maintain local supplies for emergency stock requirements of your partners.
Assist your channel partners in importing goods at a convenient port and obtaining favorable rates for freight, clearance, and local transportation.
Assist in distributing your products to multiple distributors nationwide.
Coordinate with clearing agents and customs authorities to resolve any queries related to imported goods.
Ensure that all medical devices and IVDs being sold in India have India importer-specific labeling, verifying and adding labels as required by the CDSCO.
Determine the duty structure and taxes applicable to your devices.
Maintain local supplies for emergency stock requirements of your partners.
Assist your channel partners in importing goods at a convenient port and obtaining favorable rates for freight, clearance, and local transportation.
Coordinate with clearing agents and customs authorities to resolve any queries related to imported goods.
Assist in distributing your products to multiple distributors nationwide.
| Morulaa Services | Description and Benefits of Selecting Morulaa as your Importer or Authorized Agent for Medical Device Registration in India |
|---|---|
| Regulatory Pathway | Determine the pathway for medical device registrations in India when applying via MD-14 form for the MD-15 Import License |
| Classification | Assist in classifying your medical devices and IVDs Grouping for India for the MD-14 form: Guide your team on medical device Grouping as Device, System, Family to determine the Fees payable to the CDSCO |
| Application Form | Creation of the MD-14 Application with special detailing given on brand name, accessories, medical vs non-medical components, shelf life etc. We are uniquely placed in this aspect to have the certificates, documentation vetted by experts from the Imports & Logistics Department to ensure that the form created complies not only with the CDSCO Requirements but also so that downstream in 6-9 months on obtaining MD-15 approval there are minimal roadblocks to the Importation process. |
| Predicate Comparison | We work with your regulatory team to determine the availability of international predicates in the Indian market. Our experts have in-house experience in supporting you in preparing the Predicate comparison table – this document is critical in determining your pathway in India and if additional clinical studies / expert committee hearing will be applicable on your product. |
| Queries | Responding to the Queries raised by the CDSCO as a part of the MD-14 application once the document is submitted and working closely with your team and the government till a decision on approval by the CDSCO is made. |