Nowadays, health is given much priority in all aspects. The present generation is very much conscious about having periodic checkups and maintaining a good health. This awareness has given an upper hand to the medical equipment business. The healthcare industry is booming like no other field and because of this, Medical Device Regulation India has also become equally complicated. Unlike previous years, nowadays most medical devices are required to be registered and need approval for business

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How to start a Medical Device Business in
India
Summary: In this article, we will discuss briefly the medical device
registrationprocessinIndiaandaboutallnewrulesandregulations
relevant to medical devices prior to their introduction in the Market.
Nowadays, health is given much priority in all aspects. The present
generation is very much conscious about having periodic checkups
and maintaining a good health. This awareness has given an upper
hand to the medical equipment business. The healthcare industry is
booming like no other field and because of this, Medical Device
Regulation India has also become equally complicated. Unlike
previous years, nowadays most medical devices are required to be
registered and need approval for business.
Classification of medical devices in India.
• The New rules has classified 462 products as Medical Devices
and 250 products as IVD. For devices which do not require
registration, the manufacturer requires a no objection
certificate from the respective licensing authority. In this no
objection certificate it will state that the particular device
doesn't need any registration and can be easily involved in
export and import. Although, till now no formal classification
has been done, but a draft regulation outlines the following:

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Class A – Low-risk devices like thermometers, tongue
depressors.
Class B – Low to moderate risk devices like hypodermic
needles, suction equipment.
Class C – Moderate-high risk devices like lung ventilator etc.
Class D- High-risk devices like heart valves, implantable
devices.
• In vitro diagnostic medical devices shall be classified on the
basis of parameters specified in Part II of the First Schedule, in
the following classes, namely:
(i) low risk - Class A;
(ii) low moderate risk- Class B;
(iii) moderate high risk- Class C;
(iv) high risk- Class D.
• The Central Licensing Authority shall, classify medical
devices, based on the intended use of the device and other
parameters specified in the First Schedule of the new MDR
2017.
How to Obtain Medical Device Registration India?
As we now know that some of the medical devices require
registration and some likethe non-regulated devices are exempted
from registration. But for those devices which requires registration

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must do so with the DCGI (Drug Controller General of India) before
introducing them in the market.
For new Medical Device Registration India, approval from DCGI
(Drug Controller General of India) is needed before applying for
registration. As soon as the application is received with fees the
processofevaluationbegins.Theremaybearequirementofclinical
testing and visit of the manufacturing premises by DGCI officials
during evaluation. If everything is found to be correct and
satisfactory, an approval is awarded to the company.
But it is a lonesome process and it may take about 9-18 months for
approval even if there are no clinical trials involved. The
manufacturer from foreign countries who want to register their
devicesinIndiashouldoffertheapprovalproofintheirhomemarket
along with certain proof of prior regulatory authorization in the US,
Canada, EU or Australian markets, so it can help with the process.
Your technical documentation should be reviewed by CDSCO
(Central Drugs Standard Control Organization) and after its
approval, the registration process finally gets completed.
An authorized agent having license to manufacture for sale or
distribution or wholesale license for sale or distribution under
theserules,shall makeanapplicationfor grant of importlicensefor
medical device to the Central Licensing Authority through an
identified online portal of the Ministry of Health and Family Welfare
in the Central Government in Form MD-14 for obtaining a license.
After examination of documents furnished with the application
under sub-rule (1) of rule 34 and on the basis of the inspection
report, if inspection has been carried out, the Central Licensing

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Authority may, on being satisfied, grant license in Form MD-15 or,
may reject such application for which reasons shall be recorded in
writing, within a period of nine months from the date of application.
Thepersonwhodesirestoimportmedicaldeviceundersub-rule(1),
shall apply for an import license for test, evaluation or
demonstration or training to the Central Licensing Authority in
Form MD-16.
If the Central Licensing Authority, after such enquiry, if any, is
satisfied that the requirements of these rules have been complied,
the said authority shall grant a test license in Form MD-17, or may
reject the application for reasons to be recorded in writing, within a
period of thirty days from the date the application.
Medical Device Regulations in India
Till date, the medical device regulations India, have formulated so
many new attributes that will enhance the medical device sector in
India. Like the introduction of a single online portal for the
registrationprocess.Furthermore,Auditsofthenotifiedbodiesthat
will surely enhance the device quality and alteration in the clinical
trial needs leads to innovation of new devices.
Thecentrallicensingapprovalauthority(CLAA).TheCLAA, abranch
of the CDSCO, serves as the main regulatory body for medical
devices. The CLAA will classify medical devices, and any
manufacturer seeking a less stringent classification must send
justification to the CLAA. In consultation with an expert panel on
medical devices, the CLAA also will set and enforce safety
standards, appoint notified bodies to oversee conformity

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assessment, conduct post-market surveillance, and issue
warnings and recalls for adverse events.
All medical devices will undergo conformity assessment
procedures to ensure compliance with quality and safety standards
before they are allowed on the Indian market.
The CLAA will adopt as regulatory standards the Bureau of Indian
Statistics (BIS) and International Organization for Standardization
(ISO)specificationsforqualitymanagementsystems.Tomeetthese
standards, medical devices must be designed and manufactured in
a way that achieves their intended purpose and does not
compromise patient health or safety.
What is the scope of medical devices in India?
Thus, we can say that the new medical device regulations in India
will surely encourage the country’ manufacturing quality and
enhance the business of medical devices in India.
Author Bio: Author is an expert in Indian Drug and Medical device
regulations with a keen interest in tracking and analyzing new
changes in the medical industry.