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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 Regulations. Morulaa can support your import into India as your Medical device CDSCO Agent. The Medical Device Rules, 2017 India, have been effective since January 1, 2018. Initially, only 37 medical devices were regulated under MD14, but now all medical devices and IVDs being imported into India must be classified and obtain an MD15 medical device import license.
Morulaa, via its India medical device consulting services, supports manufacturers for CDSCO SUGAM Online Portal Registration to obtain the MD15 certificate.
Importer License can be obtained via an Importer or Authorized Agent for Class A, B, C, or D medical devices to be sold in the Indian market. For Class C and Class D Medical Devices and IVDs, the Classification medical device CDSCO process is critical for compliance. The extended licensing deadline of 30 September 2023 by the CDSCO is now past over for importing devices into India.
Medical Devices and In Vitro Diagnostics (IVDs) in India are regulated by the Central Drug Standard Control Organization (CDSCO) under the Medical Device Regulations. Morulaa can support your import into India as your Medical device CDSCO Agent. The Medical Device Rules, 2017 India, have been effective since January 1, 2018. Initially, only 37 medical devices were regulated under MD14, but now all medical devices and IVDs being imported into India must be classified and obtain an MD15 medical device import license.
Morulaa, via its India medical device consulting services, supports manufacturers for CDSCO SUGAM Online Portal Registration to obtain the MD15 certificate.
Importer License can be obtained via an Importer or Authorized Agent for Class A, B, C, or D medical devices to be sold in the Indian market. For Class C and Class D Medical Devices and IVDs, the Classification medical device CDSCO process is critical for compliance. The extended licensing deadline of 30 September 2023 by the CDSCO is now past over for importing devices into India.
As per CDSCO Regulation, the MD15 Medical device import license India requires any overseas manufacturer importing devices 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 Medical device CDSCO Agent (Authorized Agent) ensures compliance with medical device regulations in India. The biggest advantage is that you can sell to Multiple Distributors, Protect Sensitive Information from Channel Partners on your Certificates, Device Technical File & Manufacturing whilst remaining Compliant Post Approval to minimize Supply chain Disruptions. Hence, maintain your independence at minimal cost via Morulaa as your India country representative or CDSCO Agent.
As per CDSCO Regulation, the MD15 Medical device import license India requires any overseas manufacturer importing devices 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 Medical device CDSCO Agent (Authorized Agent) ensures compliance with medical device regulations in India. The biggest advantage is that you can sell to Multiple Distributors, Protect Sensitive Information from Channel Partners on your Certificates, Device Technical File & Manufacturing whilst remaining Compliant Post Approval to minimize Supply chain Disruptions. Hence, maintain your independence at minimal cost via Morulaa as your India country representative or CDSCO Agent.
We authorize you to add our Indian Agent details and local contact numbers on your product labels to maintain compliance with the Medical Device Rules, 2017. As part of our services, We prepare documents as per the MD 14 Checklist India to ensure your medical device meets the regulatory requirements.
As your India country Representative, We 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 ensures seamless communication during the process to market authorization India, liaising with the CDSCO for Post Approval Changes via the CDSCO Sugam online portal in India
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 medical device import license India to ensure an easier and faster renewal process. Our team tracks the necessary timelines as per the India regulatory body CDSCO to keep your products in compliance.
Post Market Surveillance (PMS) CDSCO India, Adverse Event Reporting, Recalls, and other necessary post-market activities for market authorization India are supported by Morulaa as your Importer or License Holding Company in India.
We authorize you to add our Indian Agent details and local contact numbers on your product labels to maintain compliance with the Medical Device Rules, 2017. As part of our services, We prepare documents as per the MD 14 Checklist India to ensure your medical device meets the regulatory requirements.
As your India country Representative, We 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 ensures seamless communication during the process to market authorization India, liaising with the CDSCO for Post Approval Changes via the CDSCO Sugam online portal in India
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 medical device import license India to ensure an easier and faster renewal process. Our team tracks the necessary timelines as per the India regulatory body CDSCO to keep your products in compliance.
Post Market Surveillance (PMS) CDSCO India, Adverse Event Reporting, Recalls, and other necessary post-market activities for market authorization India are supported by Morulaa as your Importer or License Holding Company in India.
Ensure that all medical devices and IVDs being sold in India comply with Market Authorization India requirements, including India importer-specific labeling, etc.
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.
We provide medical device consultant India services to coordinate with clearing agents and customs authorities, resolving any queries related to imported goods.
Ensure that all medical devices and IVDs being sold in India comply with Market Authorization India requirements, including India importer-specific labeling, etc.
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.
We provide medical device consultant India services to coordinate with clearing agents and customs authorities, resolving any queries related to imported goods.
| 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 registration and Market Authorization India when applying via MD14 form for the MD15 Import License (Medical device import license India) |
| Classification | Assist in classifying your medical devices and IVDs Grouping for India for the MD14 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 MD14 Application with special detailing given on brand name, accessories, medical vs non-medical components, shelf life and all documents required for CDSCO MD14 Sugam online submission 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 MD15 (Medical device import license India) 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 MD14 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. |