Import License for Medical Devices in India: How the Local Import Process Works
This article deals with the import of Medical Devices into India. It also explains the Import License for Medical Devices in India for manufacturers entering the Indian market. The Medical Devices importer in India is of prime importance for every manufacturer. In order to import into India, manufacturers have to meet a certain standard of quality and efficacy to enter the Indian market. Companies importing medical equipment to India must also follow the applicable registration and customs process. The Import, Manufacture, Distribution and Sale of Drugs, Cosmetics, Medical Devices and IVDs in the country is regulated under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. The central Government monitors regulatory control over these articles imported into the country through the Central Drugs Standard Control Organization (CDSCO) overlooked by the Drugs Controller India (DCG). The Most important objective for Medical device registration and Importation in India is to ensure availability of secure, potent and quality drugs, cosmetics and medical devices based on scientific excellence and best possible regulatory practices. The Documentation required importing medical devices must adhere to these standards to facilitate seamless market entry. These documents form part of the medical device import requirements for entry into the Indian market.
Importation Services: Import License for Medical Devices in India
Morulaa is an Independent Authorized Representative for several manufacturers and we give complete support to Overseas Manufacturers for the import of their Medical Devices into India. Our medical device regulatory consulting support covers registration, importer coordination and customs documentation. The Medical Device Rule 2017, India governs these processes to ensure compliance and regulatory adherence. Previously, prior to 2018, the license holder could be a single company and several companies could have a separate Import License. However, from 2018, the Importer and the License Holder have to be the same company. Obtaining a medical device import license India is now an integral part of the process, ensuring that the importer is responsible for ensuring smooth customs clearance and compliances have to be met with regards to the import of the Medical Devices into India. A CDSCO medical device import license links the importer and license holder responsibilities under the current process. Obtaining an import license in India is now an integral part of this process. This also means the importer must meet the medical device import requirements for customs clearance and ongoing compliance.
Principle of Functioning: Medical Device Import Requirements
The following steps explain the working arrangement for importing medical equipment to India. This process is often supported through medical device regulatory consulting to reduce document errors before dispatch. When an import license in India is active, the Authorized Representative coordinates payment, dispatch and import documentation.
The Authorized Representative order EXW price to the Company
The Company supplies an EXW proforma invoice to the Authorized Representative
The Authorized Representative pays the EXW Pricing to the Company based on the Payment Terms.
CDSCO Medical Device Import License Document Verification
Before dispatch, the Authorized Representative should verify each document linked to the CDSCO medical device import license.
Verification of the following documents must be done by the Authorized Representative prior to dispatch
Airway Bill (AWB) - The Authorized Representative’s details must be mentioned correctly 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 - The dimensions of the package in the Packing List and AWB must be the same.
Certificate of Conformity (COC) - The product shelf life must be as per the CDSCO rules and must be verified by the Authorized Representative
These checks help confirm the medical device import requirements before shipment.
Importing Medical Equipment To India: Local Processes
The local customs steps are the same core steps followed when importing medical equipment to India.
Once the consignment is dispatched and lands into India, all local processes are done by the Authorized Representative. The local processes include
Authorized Representative must supply the following documents to the Clearing and Forwarding Agent (CHA)
Airway Bill (AWB)
Commercial Invoice
Packing List
ADC Sheet
Registration Certificate
Product Description
Product Brochure
Batch Release Certificate
End User Certificate
GATT Form
Importer Label
Importer Exporter Code
AD Code
GST Certificate
Wholesale Drug License
The CHA generates the Checklist Bill of Entry (BOE) which must be verified by the Authorized Representative. The duty structure, company details, packaging details etc must be verified.
Once the Checklist BOE is confirmed, the Bill of Entry (BOE) is generated for duty filing.
The BOE to be filed either in advance or on arrival. If not done on time, demurrage would be attracted.
Duty must be paid on the online
After the duty has been paid, customs examines the goods to give an Out of Charge (OOC)
Once the OOC has been generated, the Authorized Representative can collect the Package
Conclusion: Import License In India
In India, CDSCO authorized agents are required to be involved in the import and customs clearance process for Medical Devices, Cosmetics and IVD for which they hold an import license. Morulaa is committed to fair, efficient and transparent import procedures. As a Medical device CDSCO authorised Agent in India, Morulaa’s basic support includes taking title to your Package through customs clearance and ensuring safe delivery into India by adhering to the regulations under the Medical device Rule 2017, India, and ensuring all compliances are met. We also offer Local Storage and Warehousing for your Medical Devices into India. Please contact Morulaa for more information on Import of your Medical Devices into India. Morulaa can coordinate the CDSCO medical device import license and customs documentation for overseas manufacturers. Morulaa also provides medical device regulatory consulting for licensing, local representation and import coordination. Morulaa can support the Import License for Medical Devices in India, customs clearance and safe delivery.
Ensure Safe Importation with Morulaa: Medical Device Regulatory Consulting
Once the consignment is dispatched and lands into India, all local processes are done by the Authorized Representative. The local processes include
Authorized Representative must supply the following documents to the Clearing and Forwarding Agent (CHA)
Airway Bill (AWB)
Commercial Invoice
Packing List
ADC Sheet
Registration Certificate
Product Description
Product Brochure
Batch Release Certificate
End User Certificate
GATT Form
Importer Label
Importer Exporter Code
AD Code
GST Certificate
Wholesale Drug License
The CHA generates the Checklist Bill of Entry (BOE) which must be verified by the Authorized Representative. The duty structure, company details, packaging details etc must be verified.
Once the Checklist BOE is confirmed, the Bill of Entry (BOE) is generated for duty filing. The BOE to be filed either in advance or on arrival. If not done on time, demurrage would be attracted. Duty must be paid on the online Ice Gate Portal (https://www.icegate.gov.in/) After the duty has been paid, customs examines the goods to give an Out of Charge (OOC) Once the OOC has been generated, the Authorized Representative can collect the Package For support with an import license in india, Morulaa can assist with local representation and customs coordination.
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