Medical Device Customs Clearance in India: BOE & Logistics Process

Medical Device Customs Clearance Requirements in India

This article focuses on the process of customs clearance for Medical Devices in India. Manufacturers of medical equipment who want to sell in India also need to follow the registration and custom process. The central government exercises regulatory control over these articles through the Central Drugs Standard Control Organization (CDSCO), which works under the Drugs Controller India (DCG). The key objective of Medical device registration and Importation in India is that all kinds of quality and potent drugs, cosmetics and medical devices become available based on scientific data and regulatory practices.

Navigating customs clearance at Indian ports requires strict alignment between your shipping manifests (Bill of Entry, Air Waybill, Commercial Invoice) and your active CDSCO documentation. Before initiating physical cargo dispatch or duty filing, ensure your product has successfully completed the broader CDSCO medical device approval process and holds a valid Form MD-15 certificate

Customs and Logistics Services for Medical Devices in India

Morulaa is an Independent Authorized Representative for various manufacturers and we offer full support to Overseas Manufacturers for selling their Medical Devices into India. Earlier, before 2018, the license holder was a single entity and several entities were allowed to have a separate customs clearance License. However, from 2018 onwards, the Importer and the License Holder have to be one and the same entity Morulaa has a qualified team to provide this support.

Principle of Functioning: Medical Device Clearance Requirements

In cases where there is an active license in India, then the Authorized Representative will coordinate the process.

1. The Authorized Representative places EXW priced orders with the Company

2. The Company provides the Authorized Representative with EXW proforma invoices

3. The Authorized Representative pays EXW pricing to the Company according to Payment Terms.

Pre-Shipment Document Verification for Customs Clearance

Before shipment, it is imperative that the Authorized Representative validates each document associated with the CDSCO permission document MD15.

The following documents need to be validated by the Authorized Representative before shipment:

• Air Way Bill (AWB) - The name and details of the Authorized Representative needs to be as per the Registration Certificate.

• Commercial Invoice - Correct details of the Name of the Company and Products in the invoice must be as per the Registration Certificate.

•  Packing List - Dimensions of the package in Packing List and AWB need to be the same.

• Certificate of Conformity (COC) - Shelf life of the products needs to be as per the CDSCO regulations and must be validated by the Authorized Representative

Local Processes Once Goods Land in India

After the goods are shipped and arrive in India, all local procedures will be completed by the Authorized Representative. The local procedures include

• Documents to be provided by the Authorized Representative to the Clearing & Forwarding Agent (CHA) include

1. Air Way Bill (AWB)

2. Commercial Invoice

3. Packing List

4. ADC Sheet

5. Registration Certificate

6. Product Description

7. Product Brochure

8. Batch Release Certificate

9. End User Certificate

10. GATT Form

11. Importer Label

12. Importer Exporter Code

13. AD Code

14. GST Certificate

15.  Wholesale Drug License

• CHA issues the Checklist BOE which needs to be verified by the Authorized Representative. Duty structure, company name, packaging information etc needs to be verified.

• Once the Checklist BOE is verified, the Bill of Entry (BOE) is generated for duty filing.

• The BOE needs to be filed either prior to its arrival or at its arrival. In case it is not, then there will be demurrage charges.

• Duty needs to be paid online.

• After the payment of the duty, the goods are checked by the custom to release an out of charge (OOC).

• Once the OOC is issued, the authorized representative can retrieve the Package.

Morulaa: Importer of Record and Customs Support

Being a Medical Device CDSCO authorised Agent in India, Morulaa’s minimum services include taking title to your package by way of customs clearance and delivering them safely into India as per rules specified under Medical device Rule 2017, India, and meeting all the compliances. Morulaa also offers Local storage & Warehousing of your Medical Devices in India. Morulaa can facilitate CDSCO Medical Device customs documentation for the overseas manufacturers of medical devices. Morulaa offers regulatory consultancy service for Medical Devices related to licensing, representation and import coordination.