Introduction – Medical Device Importation in India

The importation of Medical Devices 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. The Import, Manufacture, Distribution and Sale of Drugs, Cosmetics, Medical Devices and IVD’s 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 manufacture, sale and distribution of Drugs, Cosmetics, Medical Devices and IVD’s  is primarily regulated by the State Drug Control Authorities appointed by the State Governments. The most important objective for Medical Device 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. 

Assistant Drug Controller 

The Drugs Controller General of India (DCGI) is a part of the Central Drugs Standard Control Organization (CDSCO), India. It is liable for approval of licenses of various categories of drugs such as blood and blood products, IV fluids, vaccines, Medical devices and Instruments in India.  All Medical products imported in India need to get a No Objection Certificate (NOC) from the Assistance Drug Controller (ADC). The ADC can enquire about the import permit of medical products as well. If the importer wishes to import  raw material, then the manufacturing license must also be provided. In an import trade, if any product contains medical related components, they are permitted with an NOC obtained from the Drug Controller Office who is authorized to manufacture such medical related products. An NOC is an approval given to the manufacturer authorized by government agencies of a manufacturing country. Pharmaceutical manufacturers and other Medicinal Related Products manufacturers compulsorily require the No Objection Certificate from the Drug Controller.

There are two major pathways for Medical Device Importation in India

  1. Notified Medical Device Importation
  2. Non-Notified Medical Device Importation

1) Notified Medical Device Importation

For Medical Device Registration in India, 37 device categories have been listed as ‘Notified Medical Devices’ by the CDSCO. These 37 devices have a separate process for registration. The manufacturer must obtain the MD-14 from the CDSCO for these 37 devices  after which he/she can import into India. All these 37 devices have a separate process for import clearance as explained below. However, the import can be done only by a person/firm/enterprise having a wholesale license and/or manufacturing license issued under Drugs and Cosmetics Act, 1940 and Rules 1945. Only they can be an applicant for Registration and import of notified medical devices into India.

Procedure of Import Clearance for Notified Medical Device in India

Documentation – Before the goods arrive, all the documents required for import clearance must be kept ready. The primary documents are – Bill of Lading or Airway Bill, Commercial Invoice, Packing List, Freight Certificate, Cargo Arrival Notice, Purchase Order or LC and other specific documents for the imported goods. 

  • Commercial Invoice- Commercial invoice is used for valuation purposes and calculation of the assessable value. It contains the value of products imported and in co – terms of shipment (EXW, FOB, C&F, CIF, etc.)
  • Packing List – It is mandatory for all shipments. The packing list helps the custom officer to determine the package  at the time of examination. 
  • Certificate of Analysis – The Certificate of Analysis refers to an accredited document that is issued by Illumina’s Quality Assurance Department. It ascertains that a product has met its predetermined product release specification(s) and quality with the details of Date of Manufacture, Date of Expiry.
  • Certificate of Origin – Certificate of origin is a  document issued by a Company from the exporting country to prove that the goods exported are made by them. (Authenticating the export origin point)
  • Air Waybill / Bill of Lading – The Air Waybill/Bill of lading is provided by the importer’s freight forwarder. It contains the details of the shipment. 
  • Insurance Certificate – The insurance certificate is an important document, you need to ensure your shipment before on board your shipment. Insurance value is also included for assessable value calculation.
  • Freight Certificate – The freight certificate is needed for EXW & FOB shipments. It entails the freight charges and Ex-work charges of a particular imported shipment. Freight charges and Ex-work charges are used for calculating the value of the assessable value.
  • Catalogue/Technical write up – The Catalog/Technical write up is required for every Medical product imported in India. Catalogue/Technical write up helps the Customs officer to understand the product and it’s appliances.
  • Import license – Import license is a license that permits a Dealer to acquire a predefined amount of specific products and a predetermined period. In India import is governed by the Foreign Trade (Development & Regulation) Act of 1992 and Export Import (EXIM) Policy. An application is made online to the Central Licensing Authority (CLA) under Form MD- 15 to obtain a license via an authorized agent. The Authorised Indian Agent  already possesses a license for distribution of medical devices. The registration has to be compliant, for the MD-14 to be issued
  • Tracking the Shipment – The shipment must be tracked properly, so that the customs can clear the cargo as early as possible. In case of any delay, the importer will have to pay demurrage to the import handling authorities.

The process for Medical Device Importation once the documents are ready is :

  1. Completion of  Customs Formalities – All the formalities with respect to the shipment must be cleared within 2-3 days, subject to producing all required documents. 
  2. Arrival Of Cargo – On the arrival of the cargo in port, the carrier of goods files the Import General Manifest (IGM) with the customs department. Usually, each aircraft or vessel has one IGM number and every consignment carries a ‘line number.’ Every shipment will have 1 IGM number and a ‘liner number.’ This number has to be entered in the specified column of Bill of Entry while filing. The IGM will be automatically linked with the importers document while uploading the bill of entry details.
  3. Bill of Entry – The Bill of Entry number is generated at one place for all the ports in India as per the software queue automatically. If your goods are under the green channel clearance, the cargo is taken directly at the port of entry with a few simple protocols. If there is any query for further documentation or a personal meeting, the importer will have to follow the same.
  4. Inspection – After the Bill of Entry assessment is completed, the document passes over for inspection. The goods are examined electronically at the customs department software system. This inspection is carried out under the supervision of necessary customs officials and it enters the examination report in the system. If the inspection report is approved by the officer in charge and no duty amount is involved, then the bill stands passed out of customs for delivery. 
  5. Collection – Prints of processed bill of entry are generated and customs officer signs physically on the Bill of Entry. Delivery of cargo can be arranged after submitting the bill of entry of ‘passed out of customs’ with the carrier of goods. The carrier, after collecting necessary charges if any, issued delivery order to the custodian of cargo. 

2) Non-Notified Medical Device Importation in India

The CDSCO brought in a new amendment on 11th February 2020,  wherein apart from above mentioned 37 notified devices, all the other devices which includes – instruments, apparatus, appliances and implants, irrespective of being used alone or in combination for various purposes like analysis, prevention, treatment, allaying of any disease, investigation, replacement or alteration or support of the anatomy among others, will be regulated under the legislation. This new Amendment is called the Medical Device (Amendment) Rules, 2020 and will be on voluntary basis for 18 months from 1st April 2020 to 1st October 2021. The import process is similar to a notified medical device, however the Certificate of Analysis is not required. To import into India, the manufacturer has to obtain a Registration Label after which the product can be imported in India. 

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