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DENTAL TECHNOLOGY, JULY-SEPTEMBER 2022

AIr of uncertAInty surrounDs the DentAl InDustry As MeDIcAl DevIces
(AMenDMent) rules coMe Into force

In February 2020, The Central Government, after consultation with the Drugs formulate a separate legislation for Medical Devices. The Parliamentary
Technical Advisory Board, specified medical devices as drugs and hence laws that Committee has also recommended to the government to come up with a 'National
were applicable to drugs were to be made applicable to these devices. These rules Commission on Medical Devices' to examine all aspects of the industry in detail
were called the Medical Devices (Amendment) Rules, 2020 and came into force on and bring forth a comprehensive law supported by a holistic policy and institu-
the 1st of April, 2020. tional infrastructure for the purpose. It remains to be seen if the government will
The idea behind these new Rules was to ensure that every medical device, either consider the recommendations of the Parliamentary panel.
manufactured in India or imported, have quality assurance before they can be dis- As recent as September 20, 2022, certain Class A medical devices were exempt-
tributed and/or sold in the market. The newly notified Medical devices listed ed from the licensing regime. As per the amendment, now for Class A devices (non
would have be registered with the Central Licensing Authority through an identi- sterile and non measuring), manufacturers and importers shall self-certify that the
fied online portal established by the Central Drugs Standard Control Organisation product is conforming to the essential principles checklist of safety and perform-
(CDSCO) for this purpose. ance of such devices. This if anything has added to the confusion for two reasons;
The registration was to be made mandatory within a specified period. One importers and manufacturers of Class A devices who have already applied for
Manufacturers as well as Importers would need to upload information specified site and product registration and paid the fees (USD 1000 per site and USD 100 for
relating to that medical device for registration on the “Online each product) have not been intimated about the refund as of
System for Medical Devices”. A registration number will be gen- now so effectively the registration fee is wasted. Secondly man-
erated which needs to be mentioned on the label of the medical ufacturers and importers of products that have not been
device. For low risk - Class A and low moderate risk - Class B the exempted (certain Class A and all class B devices) are uncertain
product would needed to be registered within 30 months (dead- if they should pay the huge registration cost involved in case
line is October 1, 2022) and for moderate high risk – Class C and there are further modifications and exemptions to the rule.
high risk – Class D devices the product needed to be registered Class B medical device registration fee stands at USD 2000
within forty-two months from the date of this notification. for site registration and USD 1000 per product. Meanwhile,
(deadline is October 1, 2023). Manufacture of class A and B representations from various Associations and Stakeholders
products are regulated by the State Licensing Authority and including ADITI (Association of Dental Industry and Trade of
import is regulated by Central Licensing Authority. India) were made to the CDSCO, requesting that the business
In a notification dated Feb 9, 2022, the MOHFW notified continuity should not be disrupted due to the implementation
that a Registration Certificate is required to sell, stock, exhibit or of licensing regime. At the time of going to press many small
offer for sale or distribute a medical device. The State Licencing Authority shall dental companies for lack of registrations had ceased sales and adopted a wait and
appoint Licensing Authorities for the purpose of issuing Registration Certificates. watch attitude.
Hence in effect Registration/ license is required to manufacture, import, dis- In view of this, CDSCO issued a public notice on 30th September 2022, which
tribute or to sell these Newly Notified Medical Devices. Additionally components said if an existing importer/manufacturer has already submitted an application to
and spare parts of medical devices also need registration. Central Licensing Authority or State Licensing Authority on or before 30.09.2022,
While the central government is making all efforts to have a single Act for phar- the said application shall be deemed valid and the importer/manufacturer can
maceuticals, medical devices and cosmetics through the new Bill, a Parliamentary continue to import /manufacture the said devices up to 6 months or till the time,
panel has strongly recommended to the government for a separate legislation for the Central Licensing Authority or State Licensing Authority, takes a decision on
the medical devices industry in the country. the application, whichever is earlier.
Interestingly the Parliamentary Committee, in its 138th report on 'Medical This brings little cheer to hundreds of dental companies and importers who are
Devices: Regulation & Control', which was presented to the heads of Rajya Sabha yet to file their applications partly because of the prevailing uncertainty and the
and Lok Sabha on September 12, said that the Committee, while welcoming the high costs involved. As a result exhibitions such as Expodent Mumbai has seen sev-
initiative of the Ministry, strongly recommends that instead of drafting a com- eral cancellations from dental companies as exhibitors cannot sell products (noti-
bined legislation for Drugs, Medical Devices and Cosmetics, the Ministry should fied medical devices) that are not registered as yet.

HUGE POTENTIAL FOR
LABORATORY 3D DENTAL
SCANNERS IN DIGITAL
DENTISTRY

Fact.MR, a US based market research and
competitive intelligence provider, has pub-
lished a new report, which reveals that the
global 3D dental scanners market is antici-
pated to reach a valuation of US$ 2.5 billion
by the end of 2027.
Dentistry curriculum set to change in India Increasing Demand For Desktop / Laboratory
3d Dental Scanners In Digital Dentistry
After MBBS, now major modifications are DCI has added chapters from forensic, basic Solutions, Rising Prevalence Of Periodontal
going to be introduced in the undergraduate and advanced life support courses. Under the Disorders, And Constant Innovations In 3d
dental education too with the introduction of credits-based system, credits will be given for Dental Imaging Technologies Are The Main
new Draft Bachelor of Dental Surgery (BDS) sports activity, participation and practice in Factors Stimulating Market Growth
course regulations, which increases the course Yoga and other soft skills. Many of the issues that traditional scanners
duration to five-and-a-half years and includes There will be nine semesters under the
a mandatory one-year internship. changed curriculum and in each semester, stu- that employ impression plates and trays face
“There will be a 360-degree change in cur- dents will get a choice to pursue two out of have been solved by 3D dental scanners.
riculum which shall be of international stan- four subjects first, and the other two later. It Patients prefer 3D digitalization impressions
dards and of four-and-a-half years plus one will increase burden upon colleges but will since they are more practical and pleasant.
year of internship, instead of the present four- benefit students by allowing them to choose 3D dental scanners can scan the complete
year course and one year of internship. the subject they wish to finish first. dental arch in less than 3 minutes, which has
Students will benefit more with the credits- The DCI has submitted its proposal been made possible with technological
based and choice-based curriculum,” said Dr for changing the dentistry curriculum to the advancements.
Mazumdar, President, Dental Council of central government which shall take the final
India. Under the changes recommended, the decision.