Institute of Good Manufacturing Practices India

By : Hartesh Juneja
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Institute of Good Manufacturing Practices India www.igmpi.ac.in

Contents
 I. Definition of Medical Devices
 II. Introduction of risk based classifications system
 III. Single window clearance
 IV. Product standards for medical devices
 V. Certainty and rationalization of timelines
 VI. Perpetual licenses
 VII. Consolidation of registration certificate and import license
 into a single license
 VIII. Certainty on consequence of change in licensed particulars
 IX. Meaning of “change in constitution” finally explained and change
 in constitution rationalized
 X. License for sale of medical devices
 XI. Mandatory recalls on knowledge of risk to safety
 XII. New thresholds for residual shelf life of imported products
 XIII. New regulatory framework for clinical investigation of medical device
 XIV. Debarment on account of supply of misleading information
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 Medical Device Rules 2017 – An Overview

The Indian Government has finally introduced the Medical Device Rules, 2017. The
rules have been drafted with the intention to distinguish medical devices from
pharmaceuticals for the purpose of regulation. They have come into effect on January
1, 2018.The key highlights of the 2017 Rules are:

 I. Definition of Medical Devices

 Under the 2017 Rules, medical devices mean :

 a. Specific devices intended for internal or external use in the diagnosis, treatment,

mitigation or prevention of disease or disorder in human beings or animals which

are notified by the government from the time to time under the Drugs and Cosmetics
Act, 1940 (“D&C Act”). Some categories of devices have already been notified by
the government. A list of classes of currently notified medical devices is annexed as
Annexure D.
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 Medical Device Rules 2017 – An Overview

b. Specific substances intended to affect the structure or any function of the human
body which are notified by the government. At present, the substances notified are
mechanical contraceptives (eg. condoms, intrauterine devices, tubal rings) and
disinfectants.

c. Surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures,

blood and blood component collection bag with or without anticoagulant;

d. Substances used for in vitro diagnosis (referred to in the 2017 Rules as “In Vitro
Diagnostic Medical Device”)

e. All substances intended to be used for or in the diagnosis, treatment, mitigation or

prevention of any disease or disorder in human beings or animals.

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 Medical Device Rules 2017 – An Overview

The most important take-away from the definition of medical devices is that only the
products that are covered by the definition of medical devices will be regulated by the
2017 Rules. Unfortunately, since the Act, in which the definition of ‘drug’ includes all the
medical devices identified above, remains unamended, the D&C Rules will continue to
apply to all medical devices. However, to avoid confusion, the 2017 Rules do clarify
that in case of any contradiction between the provisions of 2017 Rules and the Drugs
and Cosmetics Rules, 1945 (“D&C Rules”), the provisions of the 2017 Rules will have
effect.

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 Medical Device Rules 2017 – An Overview

II. Introduction of risk based classifications system

In tune with the global practice, the 2017 Rules has introduced a risked based
classification system for regulation of medical devices. The classification is as follows:
a. Low (Class A)
b. Low Moderate (Class B)
c. Moderate High (Class C)
d. High (Class D)
The method of classification is described in detail in the first schedule of the 2017
Rules. It is important to note that unlike other countries which give liberty to
manufacturers/importers to classify their product for the purpose of registration, the
2017 Rules do not provide this liberty and the manufacturers/importers will have to
follow the classification decided by DCGI. This classification will be made available on
the official website of DCGI, i.e., www.cdsco.nic.in.The classification once done, will
unfortunately be non-appealable.

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 Medical Device Rules 2017 – An Overview

An example of the difference in regulation on the basis of risk-based classification is as

follows:
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.

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 Medical Device Rules 2017 – An Overview

Similarly, for applications for grant of license to manufacture - Class A medical devices
do not require prior audit by third party or official inspection; Class B medical devices
require prior audit by third party but do not require official inspection, and; Class C or
Class D medical devices require prior official inspection.8
The application for manufacture of Class A or Class B medical device will be assessed
by the State licensing authority whereas the application for manufacture of Class C or
Class D.

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 Medical Device Rules 2017 – An Overview

III. Single window clearance

All applications for import, manufacture, sale or distribution and clinical investigation,
whether to be assessed by the DCGI or State licensing authority, will have to be made
through a single online portal of the central government.

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 Medical Device Rules 2017 – An Overview

IV. Product standards for medical devices

All medical devices will be expected to conform to the following standards, in the same
order of relevance :

a. A standard notified by central government for the medical device specifically or

which has been laid down by the Bureau of Indian Standards (“BIS”); or

b. Where (a) is absent, to a standard laid down by International Organization for

Standardization (“ISO”) or the International Electro Technical Commission (“IEC”),

or by any other pharmacopeial standards; or

c. Where both (a) and (b) are absent, to the validated manufacturer’s standards.

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 Medical Device Rules 2017 – An Overview

The clarity in products by 2017 Rules is a welcome step by the government. For much
too long, the medical device manufacturers and importers suffered because of
absence of clarity on product standards. The D&C Rules presently states that
manufacturers or importers of notified medical devices are required to confirm to BIS
standards or in absence of BIS standards, to international standards and such
standards as may be specified. There was always a question on which standards
would have to be followed when the BIS standards were not available. However, the
introduction of 2017 Rules is expected to resolve this issues

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 Medical Device Rules 2017 – An Overview

V. Certainty and rationalization of timelines

The government has brought certainty of timelines and has rationalized the time
required for obtaining licenses required to market medical devices. Under the 2017
Rules, an applicant can be certain of the time within which its application will be
decided and can also plan the time within which it can expect an audit or inspection to
happen because timelines have been assigned to each regulatory function. Further,
unlike the D&C Rules, the 2017 Rules do not give any scope to the regulators to
extend the time-line for coming to a decision for any reason whatsoever.

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 Medical Device Rules 2017 – An Overview

For instance, in case of license to manufacture Class C or Class D medical device, the
scrutiny of the application is required to submitted within forty five (45) days of the date
of the application, the inspection of the manufacturing site is required to be completed
before sixty (60) days from the date of the application, the report of the inspection has
to be forwarded to the applicant, and the decision on the application has to be
communicated within forty five (45) days from date of receipt of the inspection report.

Similarly, a decision on application to import a medical device is required to be

communicated within 9 months from the date of the application irrespective of whether
the foreign manufacturing site is inspected or not.

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 Medical Device Rules 2017 – An Overview

VI. Perpetual licenses

The licenses granted under the 2017 Rules are perpetual, meaning they will continue
to be valid unless they are cancelled. In order to save a license from getting cancelled,
the licensee is required to pay a prescribed license retention fee every five years. A
delay of ninety (90) days past the five years is acceptable provided the licensee pays a
prescribed late fee. However, if the licensee fails to deposit the license retention fee
within the aforementioned time-limit, then the license is deemed to have been
cancelled. Once a license is cancelled, the licensee will have to apply afresh for the
license. Please note that while the license may be perpetual, if a licensed manufacturer
has stopped manufacturing activity or closed the manufacturing site for a period of
thirty days or more, it is obligated to inform the appropriate licensing authority

Institute of Good Manufacturing Practices India

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 Medical Device Rules 2017 – An Overview

VII. Consolidation of registration certificate and import license into a single license

The 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.

Institute of Good Manufacturing Practices India

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 Medical Device Rules 2017 – An Overview

VIII. Certainty on consequence of change in licensed Particulars

The 2017 Rules are clear about the consequences of change in licensed particulars.
Any major change requires a prior approval from the appropriate licensing authority
(either DCGI or State licensing authority, as the case may be).Any minor change only
requires written intimation to the appropriate licensing authority within a period of thirty
days.

What constitutes major change and minor change has also been specified. For
instance, the change in name or address of the manufacturer (whether domestic or
foreign) or importer is a major change. A change in design which does not affect quality
in respect of its specifications, indication for use, performance and stability of the
medical device is a minor change.

Institute of Good Manufacturing Practices India

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 Medical Device Rules 2017 – An Overview

IX. Meaning of “change in constitution” finally explained and change in constitution

rationalized

“Change in constitution” could easily be the most dreaded event under D&C Rules,
even more than a “serious adverse event”. This is because no one seems to have any
idea about what it means. Having said that, the D&C Rules require that upon its
occurrence the license remains valid for three months only. The licensing

authority itself has issued several clarifications, FAQs and guidelines over past seventy
two (72) years but has not clarified what it means.

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 Medical Device Rules 2017 – An Overview

“But worry no more. The 2017 Rules state that change in constitution of a licensee in
relation to:

i. a firm means change from proprietorship to partnership including Limited Liability

Partnership or vice versa;

ii. a company means

a. its conversion from a private to a public company, or from a public to a private

company; or

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 Medical Device Rules 2017 – An Overview

b. any change in the ownership of shares of more than fifty per cent. of the voting
capital in the body corporate or in case of a body corporate not having a share capital,
any change in its membership; and where the managing agent, being a body corporate
is a subsidiary of another body corporate, includes a change in the constitution of that
other body corporate;

Therefore, it is now clear that at least after enforcement of 2017 Rules:

1. Change in directors will not result in change in constitution;

2. Change in shareholding by way of sale/investment will not result in change in

constitution; and

3. Change of parent shareholder due to restructuring exercise will not result in change
in constitution.
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 Medical Device Rules 2017 – An Overview

Whether or not the above events constitutes a change in constitution of the licensee
remains an enigma under the Drugs and Cosmetic Rules, 1945.

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 Medical Device Rules 2017 – An Overview

X. License for sale of medical devices

The 2017 Rules do not have separate provisions for sale of medical devices. The
provisions related to sale of drugs other than homeopathic medicines under the D&C
Rules will apply to medical device as if inserted within the 2017 Rules. All licenses for
sale of drugs other than homeopathic medicines issued prior to commencement of
2017 Rules shall be deemed to be valid for sale of medical devices as well.

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 Medical Device Rules 2017 – An Overview

The 2017 Rules do, however, address a practical difficulty faced by many distributors
in India. Implantable medical devices cannot be self-administered and therefore are
seldom bought at retail. They are stocked by hospitals for clinical use as and when
required. The hospitals sell the medical device to the patient directly on a unit basis or
as part of treatment package. However, considering the medical devices are expensive

and its demand is difficult to predict, hospitals are hesitant to purchase medical devices
in large quantities. At the same time, some of the medical devices are critical and may
be required on short notice, therefore it is in hospital’s and patients’ interest that the
hospital maintains a large stock of medical devices. As a solution to this dilemma, the
distributors transfer a sizeable stock of the medical devices to the hospital

through a stock transfer.

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 Medical Device Rules 2017 – An Overview

A stock transfer is not a sale, it is merely transfer of stock. As and when the hospital

requires a medical devices, it uses it from the stock. The distributor then charges the
hospital on the basis of its use. All the unused stock is later re-transferred to the
distributor. The proof of stock-transfer of medical devices by distributor to the hospital
is a delivery note.

The D&C Rules requires that any sale or distribution should be recorded by the
distributor. A stock transfer is not a sale or distribution, therefore it is not recorded by
the distributor. However, the presence of stock at the hospital may be interpreted as an
act of distribution. This can lead to unnecessary investigation against the distributors
by the licensing authority. In order to resolve this complication, the 2017 Rules have
permitted supply of implantable medical devices against a delivery note (challan).

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 Medical Device Rules 2017 – An Overview

XI. Mandatory recalls on knowledge of risk to safety

The 2017 Rules make it mandatory for manufacturers and importers to immediately
initiate recall in case it has reasons to believe that a medical device is likely to pose
risk to the health of a user or patient during its use and therefore may be unsafe. The
recall should aim to withdraw the medical device in question from both the market as
well as patients, indicating reasons for its withdrawal. The manufacturer and importer
initiating recall is required to inform the licensing authority about the details of the
recall.

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 Medical Device Rules 2017 – An Overview

XII. 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. This becomes an issue for importers of medical devices which
have a short claimed shelf life.

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 Medical Device Rules 2017 – An Overview

The 2017 Rules have addressed the issue by relaxing the residual shelf life
requirement for medical devices with short shelf life. 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.

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 Medical Device Rules 2017 – An Overview

XIII. New regulatory framework for clinical investigation of medical device

The 2017 Rules will introduce a new regulatory framework for clinical investigation of
medical devices. Some of the interesting provisions of this framework are:

a. A fixed timeline of ninety (90) days has been prescribed for the licensing authority

to arrive at a decision on application for permission to conduct clinical trial;

b. After obtaining permission to conduct clinical trial, the first subject is required to be
enrolled within one year;

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 Medical Device Rules 2017 – An Overview

c. New concepts of Pilot Study (i.e. exploratory study) and Pivotal Study (i.e.
confirmatory study) have been introduced with respect to approval of investigation
medical device;

d. New concept of “substantial equivalence” to predicate devices has been introduced

with respect to approval of medical devices other than investigational medical devices;

e. The clinical performance evaluation of In Vitro Diagnostic Devices is now part of the
regulatory framework;

f. Any institute, organization, hospital run or funded by the Central Government or the
State Government is exempted from payment of fees for conduct of clinical
investigation; and

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 Medical Device Rules 2017 – An Overview

g. Academic clinical trials do not require prior approval of the licensing authority for its
initiation if the data generated during the study will not be used for obtaining
manufacturing or import license.

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 Medical Device Rules 2017 – An Overview

XIV. Debarment on account of supply of misleading information

The 2017 Rules frown upon submission of misleading information along with an
application for grant of any license. It prescribes that any applicant found guilty of
submitting misleading, or fake, or fabricated documents, may be debarred by the
appropriate licensing authority for such period as it may deem fit. In other words, if any
misleading or false information is found to have been submitted to the licensing
authority, then it can debar the applicant from doing business in India. The provision
appears to be based on the jurisprudence of strict liability. It does not matter whether
the applicant knew or intended to submit misleading or false information. This should
act as a wake-up call to importers, manufacturers, distributors and researchers to
ensure that all information that is finally submitted is verified prior to submission.

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 THANKS

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