Medical Devices and In Vitro Diagnostics (IVDs) in India are regulated by the Central Drug Standard Control Organization (CDSCO). Morulaa can support your import into India as your authorized CDSCO import 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 license.
Morulaa, via its India authorise agent services, supports manufacturers for CDSCO SUGAM Online Portal access to obtain the MD15 certificate.
Importer License can be obtained via an Importer or Authorized Medical Device Import 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, the MD15 license in India requires any overseas manufacturer importing devices into India, to have a local authorized representative 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 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.Â
 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 paperwork.
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 license in 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 services to coordinate with clearing agents and customs authorities, resolving any queries related to imported goods.
Call us today, or fill out the form and we will get right back to you!
Call us today, or fill out the form and we will get right back to you!