Page 8 - ADITI 2018 Newsletter - Volume 2

Expert Communique
An Overview of Regulations for Dental
Products / Devices in India under GSR
78EIn India
The Medical Devices are getting Regulated under
CDSCO (Central Drugs Standard Control
Organization). CDSCO is the Apex Regulatory Body
under Ministry of Health and Family Welfare in India.
The Medical Devices Originally were Regulated
Under Drugs and Cosmetics Act of India 1940 and
Rules 1945 Thereunder. In 2005 the Regulation for
Medical Devices was implemented. On 31st January
2017 the New Medical Device Regulations were
published and they have become effective from 1st
January 2018. Title of These Regulations is GSR 78E
It means many medical devices including Dental
Products / Devices have come under these
regulations.
Positive Point about These Regulations: These
Regulations are definitely going to be enforced but in
a Phase Manner. That means that These Regulations
will not be enforced on all Medical Devices in Single
Enforcement, rather gradually including more and
more products under These Regulations through
Gazette Notification. CDSCO Will publish the list of
Notified Devices from Time to Time.
However, as These Regulations are already
published for Indian Manufacturers and Foreign
manufacturers, the Dental Products that have been
included so far in the list include:
 Dental Implants and Abutments
 Bone Grafts and Membranes
 Orthodontic Wires
 Doing Retailing, they can import from foreign
Out of the above-mentioned dental devices, the
Dental Implants and Abutments, Bone Grafts and
Membranes were already requiring License for Import
or Manufacture in India.So, Orthodontic Wires have
come under These Regulations, however when we
see the description of the Orthodontic Wires: A wire
conforming to the alveolar or dental arch that can be
used with dental braces as a source of force in
correcting irregularities in the position of the teeth. So Shri Kant Tiwari
It means that dental braces / brackets are already
covered.Still if there is any clarification required, the
formal information can be obtained from CDSCO.
CDSCO has classified all Medical Devices including
dental devices as:
Class A, Low Risk Devices: Like Dental Chair Units,
Dental Overhead Lights, (Not Yet Mentioned in the
list )
Class B, Moderate Risk Devices: Like Orthodontic
Wires
Class C, High Risk Devices: Like Dental Implants,
Bone Grafts, Membranes,
Class D, Highest Risk Devices like Coronary Stents,
Knee Joints, Hip Joints.
The time that will be taken to include more products
can be assessed by considering that so many high
risk and highest risk devices like Pacemakers, CT
Scan, MRI, Ultrasound, X-ray are yet to be notified.
So it seems that the addition of many class A, and
Class B dental devices will take time.
The affected Business Organizations that deal in
These Regulated Dental Devices are:
1.Indian Manufacturers
2.Foreign Manufacturers
3.Indian Distributors
4.Indian Retailers.
The licenses that are applicable on these Business
Organizations are:
1.Manufacturing License for Indian Manufacturers
2.Loan License for Indian Traders who are willing the
Original Licensed Manufacturers to manufacture
under their own brand name.
3.Import License for the Indian Distributors who are
willing to import these devices from foreign
manufacturers.
4.Retailers may continue to sell the devices just like
previously.
IMPORTANT: If a company is only Distributing or Only
manufacturer registered in India or purchase from
domestic licensed manufacturer, however It is Illegal
to purchase the bulk devices and pack in an
unlicensed premises without approval of the facility to
the re-packing and re-labeling.
We Welcome the Questions and Clarification
Requirements from ADITI.
Director: DKNSB Medical Device Consultants