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Authorized Importer and Process to Import Medical Device in India

Optimizing Medical Device Imports to India

India Import Process Overview

Importing medical devices into India involves several steps and requires obtaining an India medical device import license and compliance with medical device regulations and customs procedures as per Medical Device Rules, 2017 India published by the CDSCO.The process to register in India begins with the compilation of necessary Documents required by the CDSCO via the MD14 application form on the Sugam online portal. This application has to be made by your CDSCO Medical device Authorized Agent or Importer. This company also serves as your  license holding company for the Indian market. Once the dossier is complied, they have to be submitted to the SUGAM portal of the Central Drugs Standard Control Organization (CDSCO). Once submitted, the compiled dossier undergoes review, during which any queries raised by CDSCO must be addressed promptly to complete medical device registration in india. Upon successful review, the DCGI at the CDSCO issues a registration and import certificate MD15  (Medical device import license in India), allowing for the importation of medical devices into India.

End-to-End India Solution: Importation, Customs Clearance, and Distribution

Once the MD-15 (Medical device import license in India) is obtained from the DCGI by your Medical device CDSCO Agent, the importation process begins. The distributor issues a PO to Morulaa for the medical devices. Morulaa will then raise a PO to the Manufacturer who then provides a Proforma Invoice (PI) to Morulaa. Morulaa in turn generates a Proforma Invoice (PI) to the distributor.  The payment terms, delivery schedule and all other commercial discussions are directly handled between the manufacturer and distributor.

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End-to-End Solution: Importation, Customs Clearance, and Distribution

Once the MD-15 (Medical device import license in India) is obtained from the DCGI by your Medical device CDSCO Agent, the importation process begins. The distributor issues a PO to Morulaa for the medical devices. Morulaa will then raise a PO to the Manufacturer who then provides a Proforma Invoice (PI) to Morulaa. Morulaa in turn generates a Proforma Invoice (PI) to the distributor.  The payment terms, delivery schedule and all other commercial discussions are directly handled between the manufacturer and distributor.

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Advantages of Having Morulaa as Your Importer in India

Experience in Handling Imports

Morulaa, as a leading medical device consultancy, has extensive experience as an Importer in managing the process of importing medical devices into India, ensuring smooth and compliant entry of devices.

Compliance Expertise

Morulaa’s in-depth knowledge of licensing, regulations, registration processes and certification requirements ensures efficient compliance with all regulatory requirements and shipping logistics for the medical devices.

Warehousing Capabilities

Morulaa’s in-depth knowledge of licensing and certification requirements, along with medical device consulting services in India, ensures efficient compliance with regulatory requirements.

Financial Transactions Management

Morulaa handles all financial transactions while selling the medical device, ensuring transparency and efficiency. The distributor pays Morulaa, who then pays the manufacturer.

Single Point of Contact

Morulaa acts as a single point of contact, simplifying communication and coordination for manufacturers.

Negotiated Rates

Due to handling large-scale bulk imports, Morulaa can negotiate better rates, reducing overall costs for manufacturers exporting to India.

Customs Clearance Support

Morulaa provides comprehensive support during customs clearance, including documentation and liaison with customs house agents (CHAs) for the medical devices.

Transparent Operations

All medical device shipping documents and transactions are shared with the distributor, ensuring complete transparency throughout the process of importing medical devices into india.

Experience in Handling Imports

Morulaa, as a leading medical device consultancy, has extensive experience as an Importer in managing the process of importing medical devices into India, ensuring smooth and compliant entry of devices.

Compliance Expertise

Morulaa’s in-depth knowledge of licensing, regulations, registration processes and certification requirements ensures efficient compliance with all regulatory requirements and shipping logistics for the medical devices.

Warehousing Capabilities

Morulaa’s in-depth knowledge of licensing and certification requirements, along with medical device consulting services in India, ensures efficient compliance with regulatory requirements.

Financial Transactions Management

Morulaa handles all financial transactions while selling the medical device, ensuring transparency and efficiency. The distributor pays Morulaa, who then pays the manufacturer.

Single Point of Contact

Morulaa acts as a single point of contact, simplifying communication and coordination for manufacturers.

Negotiated Rates

Due to handling large-scale bulk imports, Morulaa can negotiate better rates, reducing overall costs for manufacturers exporting to India.

Customs Clearance Support

Morulaa provides comprehensive support during customs clearance, including documentation and liaison with customs house agents (CHAs) for the medical devices.

Transparent Operations

All medical device shipping documents and transactions are shared with the distributor, ensuring complete transparency throughout the process of importing medical devices into india.

Steps to Import a Medical Device in India

Step 1

Prepare Invoice

The invoice should include a detailed product description of the medical device, quantity, unit price, total value, and terms of sale. This document is crucial for customs and financial transactions.

Step 2

Create Packing List

The packing list must itemize all packages, including their dimensions, weight, and contents. This helps in verifying the shipment's contents during customs clearance.

Step 3

Obtain Certificate of Analysis (COA) (if applicable)

The medical device Certificate of Analysis certifies product quality and compliance with regulations. This document is necessary to ensure the medical device meets regulatory requirements.

Step 4

Draft Air Waybill (AWB)

The Air Waybill includes preliminary shipment details, such as shipper, consignee, flight details, and handling instructions. It serves as a receipt for the goods and a contract of carriage.

Step 5

Confirm Mandatory Documents

All mandatory medical device documents, including the MD 14 Checklist and the medical device import license, must be confirmed by Morulaa before dispatch. This step ensures that all required paperwork is in order before the shipment leaves for india

Step 6

Engage with Customs House Agent (CHA) in India

During customs clearance, the distributor either connects with Morulaa's Customs House Agent (CHA) or uses Morulaa's CHA in Chennai. This agent assists with the clearing process and provides necessary documentation.

Step 7

File Bill of Entry (BOE)

After distributor confirmation, the Bill of Entry (BOE) is filed at the Indian Port. This document is essential for the legal importation of goods and must be submitted to customs authorities.

Step 8

Settle Local Expenses and Issue Tax Invoice

After customs clearance, a tax invoice is issued to the distributor. Local expenses must be settled before dispatch, ensuring all financial obligations are met. The goods are then shipped with an attached invoice and waybill, and the Maximum Retail Price (MRP) is capped at a 10% annual increase.

Steps to Import a Medical Device in India

Step 1

Prepare Invoice

The invoice should include a detailed product description of the medical device, quantity, unit price, total value, and terms of sale. This document is crucial for customs and financial transactions.

Step 2

Create Packing List

The packing list must itemize all packages, including their dimensions, weight, and contents. This helps in verifying the shipment's contents during customs clearance.

Step 3

Obtain Certificate of Analysis (COA) (if applicable)

The medical device Certificate of Analysis certifies product quality and compliance with regulations. This document is necessary to ensure the medical device meets regulatory requirements.

Step 4

Draft Air Waybill (AWB)

The Air Waybill includes preliminary shipment details, such as shipper, consignee, flight details, and handling instructions. It serves as a receipt for the goods and a contract of carriage.

Step 5

Confirm Mandatory Documents

All mandatory medical device documents, including the MD 14 Checklist and the medical device import license, must be confirmed by Morulaa before dispatch. This step ensures that all required paperwork is in order before the shipment leaves for india

Step 6

Engage with Customs House Agent (CHA)

During customs clearance, the distributor either connects with Morulaa's Customs House Agent (CHA) or uses Morulaa's CHA in Chennai. This agent assists with the clearing process and provides necessary documentation.

Step 7

File Bill of Entry (BOE)

After distributor confirmation, the Bill of Entry (BOE) is filed at the Indian Port. This document is essential for the legal importation of goods and must be submitted to customs authorities.

Step 8

Settle Local Expenses and Issue Tax Invoice

After customs clearance, a tax invoice is issued to the distributor. Local expenses must be settled before dispatch, ensuring all financial obligations are met. The goods are then shipped with an attached invoice and waybill, and the Maximum Retail Price (MRP) is capped at a 10% annual increase.

Streamline Your Medical Device Market Entry into India with Morulaa

Partnering with Morulaa HealthTech as your India Country Representative or Medical device CDSCO Agent to be successful in the market.  We are a consultant in India for medical devices, and support medical device manufacturers to seamlessly navigate the complex import process by the CDSCO and manage the SUGAM account. Utilize Morulaa’s expertise, negotiated rates, compliance knowledge, post market surveillance (PMS) CDSCO India, CDSCO regulations and warehousing capabilities. This collaboration simplifies regulatory and customs procedures, including assistance with post market surveillance (PMS) CDSCO India, ensuring cost-effective and efficient market entry for the importer. By leveraging Morulaa’s comprehensive support, manufacturers can maximize their medical devices’ potential in the Indian market.

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