What You Should Know About Medical Device Registration In India?
by Divya S. Content WriterWith
the invent of more and more devices, the rules for its regulations have been changed
in India. As India is playing a major role in marketing of these devices in
Asia, and beyond, regulating Medical Devices poses a real challenge, upon implementation
of the Medical Device Rules, 2017.
In
this article we will discuss about how to register a new Medical Device Registration
India and how to carry out import of cosmetics.
Today,
India’s medical device sector is dominated by multinational companies, which is
evident from the fact that India relies on imports of medical devices (about
75-80% of the sales are generated by imported medical devices) to supply its
healthcare system.
Thus,
because of the increasing opportunities, the regulations are becoming stricter
and companies are facing more complications. This process can be made simpler
and manageable with the assistance and help of consultants.
CliniExperts serves as
an authorised Indian agent and provides end to end solution right from product
classification and its respective documentation submission, labelling
requirements, follow ups and obtaining the permissions.
There are more than
500 Medical Device Regulation
India and in vitro diagnostic medical devices which are required to
be registered before they are intended for marketing in India, all
other requires a no objection certificate from DGCI, for selling. This no
objection certificate (NOC) states that the product doesn’t requires
registration and is free for import in India.
The regulatory bodies
responsible for Medical device registrations are:
·
The Central Drug
Standards Control Organization (CDSCO) under Directorate General of Health
Services in Ministry of Health and Family Welfare, Government of India is the
National Regulatory Authority (NRA) responsible for approval of manufacturing,
import, conduct of clinical trials, laying down standards, sale and
distribution of medical devices through enforcement and implementation of the
Medical Devices Rules, 2017.
·
The Drug Controller
General of India (DCGI) shall be the Central Licensing Authority
responsible for enforcement of rules in matter pertinent to import of all
Classes of medical devices.
·
Drugs & Cosmetic
Act 1940 & Rules 1945 are responsible for manufacturing, import, sale and
distribution of medical devices.
·
The State Drugs
Controller serves as the State
Licensing Authority (SLA) and shall be the competent authority for enforcement
of the rules relating to the manufacture of Class A or Class B medical devices
and the sale, stocking and exhibition of medical devices and other related functions.
Classification of
medical devices
Class
A – Low Risk like thermometers, tongue depressors
Class
B – Low-moderate Risk like hypodermic needles, suction equipment
Class
C – Moderate-high risk like lung ventilator, bone fixation
Class
D – High Risk like heart valves, implantable devices
Process of medical
device registration in India:
For Class A & B
Medical devices,State Licensing Authority (SLA) shall be the competent
authority for enforcement of the rules relating to the manufacture sale,
stocking and exhibition of medical devices and other related functions.
For Class C and Class
D high-risk medical devices, Central Licensing Authority (CLA)oversees the
clinical investigation and clinical performance evaluation of medical devices
and has other related functions.
If
the manufacturer intends to manufacture a predicate medical device, the
manufacturer must receive approval from the CLA before applying to the SLA.
For
import or manufacture of new medical device (without predicate), an application
for grant of permission for such medical device after completion of its
clinical investigation shall be made to the Central Licensing Authority in Form
MD-26 accompanied with fee either by an authorised agent in case of import or a
manufacturer.
DGCI
may evaluate the application received along with fees and may require clinical
testing of the device either in India or abroad.During the whole process, DGCI
may make a visit to the manufacturing unit. After review of the application. it
sends anenquiry letter to applicant for further response.DGCI may sometimes
require a technical presentation and then approves the
application.The whole process of registration may take about 9-18 months if there
exist no clinical trials.
In
India, one of the largest industries is the cosmetic industry that is spreading
in a very speedy rate and its size is more than that of US and Europe. Because
of this to assure that the products are safe for using Ministry of Health and
Family Welfare in India has introduced many rules in which a registration
certificate is needed for importing cosmetics in India. So, if you have any
plan to initiate a cosmetics business in India, then there are specific
guidelines you are required to follow.
The
manufacturer of the cosmetics should have a registered office in India.The
cosmetics should be registered with Central Drugs Standards Controller India
under Ministry of Health and Family Welfare. Application form is filled up and
submitted to concerned authority both in electronic and hard copy.The
registration certificate is issued well within 6 months after submission and
the certificate is valid till 3 years after which renewal is required for
continuing the business. Some of the documents required are a valid import
export code, payment proof of fees, all details about cosmetics and the
manufacturing license, list of countries where the product has permission. All
details about the ingredients of the cosmetics, and methods of testing and
product specification.
Thus,
whether it is medical device registration or Cosmetic Import India
you are required to follow certain guidelines.
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Created on Apr 15th 2019 03:04. Viewed 431 times.