Medical Device Importation in India

Introduction – Medical Device Importation in India:

The importation of Medical Devices in India is of prime importance for every Medical device manufacturer and the authorized importer. 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. This is further amended to include Medical device Rules, 2017 (MDR 2017 – DCGI) and Cosmetic Rules, 2020. 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 (DCGI). 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 based on the guidelines set by the CDSCO under the Medical Device Regulations.

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 go through a check with the port specific Assistance Drug Controller (ADC) of CDSCO. The ADC can enquire about the registration and 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:

For Medical Device Registration in India previously 37 device categories have been listed as ‘Notified Medical Devices’ as per the Indian Medical Device regulation Guidelines set by the CDSCO under the Medical device Rules, 2017 (MDR 2017 ). Now ALL devices with an intended medical purpose either as whole or component or accessories, require registration with the CDSCO in Form MD-15 (import license) for sales, distribution and marketing in India as mandated in India Medical device Rules, 2017 (MDR 2017) . For example sterile instruments, apparatus, appliances, software 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 new amended legislation published in February 2020. Please refer to our blog on CDSCO Medical Device Amendments to review the process and documentation required for medical device Import license in India as per the guidelines mentioned in the Medical Device Regulations.

The Non-Notified Medical Device Importation (Class A non-sterile and non-measuring) requires importers to get an automatic registration number with the CDSCO by submitting the required documents on the online SUGAM portal and obtain Medical device approval. Please refer to our blog on CDSCO Medical Device Amendments to understand more on this process.

Procedure of Import Clearance for Medical Device in India:

Prerequisite for an Authorized Indian Agent :
Irrespective of the medical devices being notified or non-notified, the process for import clearance remains the same and is as explained below. An authorized importer is an Indian person/firm/enterprise having a wholesale drug license in Form 20B and Form 21B/21C and/or medical device registration certificate for sales and distribution in Form MD-42. Along with this the importer in India needs to have a valid Import Export Certificate (IEC) and other necessary company registration documents as per the guidelines mentioned in the Medical Device Regulations.

Documentation Required :
Before the goods arrive, all the documents required for import clearance must be kept ready as per the guidelines mentioned by the CDSCO. 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.
Catalog/Technical write up - The Catalog/Technical write up is required for every Medical product imported in India. Catalog/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-14 to obtain a MD-15 Import license via an authorized agent. The Authorized Indian Agent already possesses a license for distribution of medical devices. The registration has to be compliant as per the Medical Device Regulations, for the MD-15 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:

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.
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.
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.
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.
Collection - Print of a processed bill of entry are generated and the 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 a delivery order to the custodian of cargo.

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