Import Process Overview

Importing medical devices into India involves several steps and requires compliance with both regulatory and customs procedures. Here is a detailed breakdown of the process:

• Dossier Compilation: Your Indian agent or importer compiles the necessary documents and submits them to the SUGAM portal of the Central Drugs Standard Control Organization (CDSCO).

• SUGAM Submission: The compiled dossier is submitted through the SUGAM portal for review.

• Respond to Queries: Any queries raised by CDSCO during the review process must be addressed promptly.

• Registration & Import Certificate: Upon successful review, a registration and import certificate is issued by CDSCO.

Importation and Customs Clearance to Delivery to Selected Distributor

The importation process begins with the pre-dispatch phase, where the manufacturer provides a Proforma Invoice (PI) to Morulaa based on commercial discussions with the distributor. Morulaa then provides the PI to the distributor for the product value, accounting for forex fluctuations. The distributor, in turn, provides a Purchase Order (PO) to Morulaa, and payment terms are agreed upon.

Once the dispatch from the manufacturer is ready, key documents such as the invoice, packing list, Certificate of Analysis (COA), and Air Waybill (AWB) draft must be shared with Morulaa. It is crucial to ensure all mandatory documents, including those required for MD-14 compliance, are confirmed by Morulaa before dispatch.

Documents a Manufacturer must send with the Goods

• Invoice

• Packing List

• Certificate of Analysis (COA) (if applicable)

• Air Waybill (AWB) draft
  

Customs Clearance

With the import certificate, the medical devices can proceed through customs clearance, involving several steps:

• Shipment Lands in India: The shipment arrives at an Indian port.

• Customs Assessment & BOE Duty Payment: The Bill of Entry (BOE) is filed, and applicable duties are paid.

• ADC Clearance: The Assistant Drug Controller (ADC) at the customs port reviews and clears the shipment.

• Shipment is Cleared: Once cleared by ADC, the shipment enters India and is ready for distribution.

During the customs and clearance phase, the distributor either connects Morulaa with its Customs House Agent (CHA) or has Morulaa handle the clearance in Chennai using its own CHA. Morulaa provides the clearing documents to the CHA, and after the distributor confirms, the Bill of Entry (BOE) is filed. All costs related to customs duties, processing fees, freight, and local taxes are covered by the distributor.

Once the goods have cleared customs, a tax invoice is issued to the distributor. All local expenses must be settled before dispatching the goods. The goods are then shipped with an invoice and an e-way bill. It is essential to ensure the importer label is attached and that the Maximum Retail Price (MRP) is set with an annual increase cap of 10%.

Advantages of Having Morulaa as the Independent License Holder

1. Experience in Handling Imports: Morulaa has extensive experience managing the importation process, ensuring smooth and compliant entry of medical devices into India.

2. Negotiated Rates: Due to handling bulk imports, Morulaa can negotiate better rates, reducing overall costs for manufacturers.

3. Compliance Expertise: Morulaa’s in-depth knowledge of licensing and certification requirements ensures all regulatory compliances, including those required by MD-14, are met efficiently.

4. Warehousing Capabilities: With warehousing solutions, Morulaa can manage inventory effectively, ensuring timely distribution to customers.

5. Single Point of Contact: Morulaa acts as a single point of contact, simplifying communication and coordination for manufacturers.

6. Financial Transactions Management: Morulaa handles all financial transactions, ensuring transparency and efficiency. The distributor pays Morulaa, who then pays the manufacturer.

7. Customs Clearance Support: Morulaa provides comprehensive support during customs clearance, including documentation and liaison with CHAs.

8. Transparent Operations: All documents and transactions are shared with the distributor, ensuring complete transparency throughout the process.

By partnering with Morulaa HealthTech, manufacturers can navigate the complex import process with ease, leveraging Morulaa’s expertise, negotiated rates, compliance knowledge, and warehousing capabilities. This partnership not only simplifies the regulatory and customs procedures but also ensures cost-effective and efficient market entry, maximizing the potential for medical devices in the Indian market.