Import License for Medical Devices in India: From Registration to Customs Clearance

Import License for Medical Devices in India: How the Local Import Process Works

This piece of writing will focus on the process of Medical Device Imports into India. The process of Import License for Medical Devices in India for manufacturers who are willing to operate in the Indian market will be discussed here too. It is quite obvious that the Medical Devices importer in India holds high importance for every single manufacturer. For getting access to the Indian market for their products, manufacturers need to be of some particular standard in terms of quality and efficacy of the product. Manufacturers of medical equipment who want to import in India also need to follow the registration and custom process. The Import, Manufacture, Distribution and Sale of Drugs, Cosmetics, Medical Devices and IVDs in the country are governed by the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. The central government exercises regulatory control over these articles which are imported into the country 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 excellence and regulatory practices.

Importation Services: Import License for Medical Devices in India

Morulaa is an Independent Authorized Representative for various manufacturers and we offer full support to Overseas Manufacturers for the import of their Medical Devices into India. The medical device regulatory consulting support services include the registration, importer coordination, and the customs documentation of the medical devices. The Medical Device Rule 2017, India controls this process. Earlier, before 2018, the license holder was a single entity and several entities were allowed to have a separate Import License. However, from 2018 onwards, the Importer and the License Holder have to be one and the same entity. Medical device import license India is an essential part of this process, as the importer will have to ensure smooth customs clearance and there have to be certain compliance issues that need to be adhered to for the import of the Medical Devices into India. The CDSCO medical device import license links the importer and the license holder duties under the new process. Getting an import license in India is now an integral part of this process.

Principle of Functioning: Medical Device Import Requirements

The above steps demonstrate how the importing of medical equipment into India works. This process can be made easier through medical device regulatory consulting so as to avoid document errors prior to dispatching. In cases where there is an active import 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.

CDSCO Medical Device Import License Document Verification

Before shipment, it is imperative that the Authorized Representative validates each document associated with the CDSCO medical device import license.

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

This validation ensures compliance of the medical device import requirements.

Importing Medical Equipment To India: Local Processes

The local procedures involve the same basic steps that are taken during the importation of medical devices 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.

Conclusion: Import License In India

In India, CDSCO authorized Agents are expected to be part of the Import Process and Customs Clearance for Medical Devices, Cosmetics and IVD for which they have obtained Import License from CDSCO. Morulaa is dedicated towards the efficient import process of products. 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. Contact Morulaa for further information on Import of your Medical Devices in India. Morulaa can facilitate CDSCO Medical Device import license and customs documentation for the overseas manufacturers of medical devices. Morulaa offers regulatory consultancy service for Medical Devices related to licensing, representation and import coordination. Morulaa can facilitate Import License of Medical Devices in India, customs clearance and safe delivery.

Ensure Safe Importation with Morulaa: Medical Device Regulatory Consulting

The consignment once sent out and reaches India, all local procedures are carried out by the authorized representative. Local procedures include

The authorized representative is required to provide the following documents to the Clearing & Forwarding Agent (CHA).

1. AWB (Air Way Bill)

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

The CHA produces the checklist of the Bill of Entry (BOE) which should be verified by the Authorized Representative. The duty structure, company particulars, packaging particulars etc. should be verified.

After the verification of the Checklist BOE, the Bill of Entry (BOE) is created for filing of duties. The BOE for filing should be either filed in advance or on arrival basis. Failure to file in time will invite demurrage charges. The duty should be paid online at the ICE gate Portal (https://www.icegate.gov.in/). Once the duty has been paid, customs will check the cargo and issue Out Of Charge (OOC). After the OOC has been produced, the Authorized Representative can retrieve the Package.

Morulaa can help in case you require an import license in India.