Medical Devices and Import Protocols

By Group 2 :

Jyoti Jangid

Hemant Kumar Verma

Ojaswini Chauhan

Lakshmiswaroopa Inaganti

Ravia

Sanjita Biswas

Shuvam Garabadu

In India, imported products account for 80% of medical device sales. Most and the Drug of those devices
were actually developed for middle and high-income countries and are far removed from India’s unique
challenges of accessibility and affordability.

Intro- The importance 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.

considering its population, coupled with poor access to affordable health care, India has the opportunity to
significantly enhance reach of diagnosis if affordable and user-friendly medical devices can be injected into
the health care delivery systems. Not only India is a relatively untapped market with significant room for
growth due to increasing disposable income, more affordable medical devices could make healthcare far
more accessible, especially for the underserved.

Domestically, there are 750–800 medical device manufacturers, with an average investment of $2.3–2.7
million and an average turnover of $6.2–6.9 million. The lack of scale in the domestic manufacturing market
leads to a lack of consolidated supply chains to efficiently distribute products at scale. At the same time,
medical device distribution suffers from heavy fragmentation due to several challenges such as varied pre-
sales requirements from state to state (as required by the Constitution) and overlapping of responsibilities
such as inventory support and marketing outreach. As a result, device companies have to hire multiple
distributors in order to reach any significant scale and profitability.
The Medical Device Rules, which went into effect in January of 2018, are expected to fill a regulatory void due
to the absence of any prior medical device-specific legislation in India. However, the new rules still cover only
498 devices and leave crucial devices like MRIs and CT scan equipment out of the current regulatory
jurisdiction. Coupled with lax enforcement, the sector chronically suffers from the prevalence of notorious
fly-by-night operators delivering products of inferior quality, giving innovators a bad rap and further delay
their adoption.

Introduction of risk-based classifications system

In tune with the global practice, the Medical Devices 2017 Rules has introduced a risked based
classification system for regulation of medical devices. The classification are as follows:

a. Low (Class A)

b. Low Moderate (Class B)

c. Moderate High (Class C)

d. High (Class D)

The application for license to import Class A or Class B medical devices from Unregulated Jurisdictions
(defined below) can be granted on the strength of a free sale certificate and either of published safety
and performance data or clinical investigation in the country of origin. However, an application for
import of Class C or Class D medical devices from Unregulated Jurisdictions can be granted only after its
safety and effectiveness has been established through clinical investigation in India. Unregulated
Jurisdictions are jurisdictions other than Australia, Canada, Japan, European Union Countries, or the
United States of America.

Consolidation of registration certificate and import license into a single license :

The Medical Devices 2017 Rules have done away with the requirement of a registration certificate for
registration of the foreign manufacturer, its manufacturing site and the products. The only regulatory
requirement to be able to import and market products in India is to appoint an authorized agent in India
and apply for an import license through it. The immediate outcome of this change is that the hassle of
making two separate applications (registration and import license) has vanished and the timeline for
obtaining the import license (of nine months) has become certain. Further, it will not be possible for two
different importers to import different products manufactured at the same manufacturing site. Where
an importer has been licensed to import certain products from a manufacturing site, all other products
manufactured at the same site are mandatorily required to be licensed to the same importer.

New thresholds for residual shelf life of imported products :

The D&C Rules prescribe that all imported products should have a minimum residual shelf life of sixty
(60) percent on the date of import unless specific permission is obtained to the contrary.36 This
becomes an issue for importers of medical devices which have a short claimed shelf life. The 2017 Rules
have addressed the issue by relaxing the residual shelf life requirement for medical devices with short
shelf life.37 Any medical device, whose total shelf life claim is a. less than ninety (90) days, will be
allowed to be imported if it has more than forty (40) per cent residual shelf-life on the date of import b.
between ninety (90) days and one (1) year, will be allowed to be imported if it has it has more than fifty
(50) per cent residual shelf-life on the date of import c. is more than one (1) year, will be allowed to be
imported by the licensing authority if it has more than sixty (60) per cent residual shelf-life on the date
of import.

2 major pathways for medical device importation in India

1. Notified medical device importation

1)Notified Medical Dev ice importation

37 device categories have been listed as “Notified medical device importation” by the CDSCO. These
have a separate process for registration. The manufacturer must obtain MD-14 from the CDSCO for
these devices after which they can import to India. Also, 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 notified
med devices.

Procedure of import Clearance

Documentation – before the good arrive all the documentation must be kept ready. The primary
documents are

Commercial invoice - Used for value analysis

Packing list - It helps the custom officer at the time of examination to determine the package

Certificate of Analysis - It shows that the product has met the predetermined product release
specification and quality.

Certificate of Origin - Issued by exporting company

Air Waybill - Contain details of shipment provided by freight forwarder.

Insurance Certificate - Important for calculation of value of assessable value.

Freight Certificate - It contains the freight charges and ex work charges for a imported shipment.

Catalogue/Technical write up - It helps the custom officer to understand the product and its appliances

Import license - It permits a dealer to acquire a predefined amount of specific products.

Tracking of Shipment - It is important so that the customs can clear the cargo asap.

After the documents are ready -

1. Completion of Customs formalities –These formalities must be completed within 2-3 days.

2. Arrival of Cargo- An IGM (Import General Manifest) is filed and a “Line Number is generated. The
IGM will be automatically linked with the importers document during bill of
entry
 3. Bill of Entry – The bill of entry number is generated at one place for all ports in India as per the
software queue automatically.

4. Inspection - the documents are inspected electronically. This is carried out under the supervision
of necessary custom officials. After the approval, no duty amount is involved, the bill stands passed out
of customs for delivery.

5.Collection- prints of bill of entry are generated, after submission of these prints delivery of cargo is
arranged by issuing a delivery order.

2) Non- Notified Medical Device importation

The CDSCO brought in a new amendment on 11 th February 2020, wherein all other devices apart from
the 37 notified ones, irrespective of being used alone or in combination for various purposes like
analysis, prevention, treatment, investigation, will be regulated under the legislation. The import
process is similar to a notified medical device, however the Certificate of Analysis is not required

To import to India, the manufacturer has to obtain a Registration Label after which the product can be
imported in India.