06/10/2026
Medical Device Need CDSCO Registration in India
๐๐จ๐๐ฌ ๐๐จ๐ฎ๐ซ
๐๐๐๐ข๐๐๐ฅ ๐๐๐ฏ๐ข๐๐ ๐๐๐๐ ๐๐๐๐๐ ๐๐๐ ๐ข๐ฌ๐ญ๐ซ๐๐ญ๐ข๐จ๐ง ๐ข๐ง ๐๐ง๐๐ข๐
Bringing
a medical device to the Indian market involves more than simply importing or
manufacturing the product. ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ ๐๐ฅ๐๐ฌ๐ฌ๐ข๐๐ข๐๐๐ญ๐ข๐จ๐ง, ๐ฅ๐ข๐๐๐ง๐ฌ๐ข๐ง๐ ,
๐๐จ๐๐ฎ๐ฆ๐๐ง๐ญ๐๐ญ๐ข๐จ๐ง, ๐ญ๐๐ฌ๐ญ๐ข๐ง๐ , ๐ฅ๐๐๐๐ฅ๐ฅ๐ข๐ง๐ , ๐๐ง๐ ๐ฉ๐จ๐ฌ๐ญ-๐ฆ๐๐ซ๐ค๐๐ญ ๐๐จ๐ฆ๐ฉ๐ฅ๐ข๐๐ง๐๐ may all need
to be addressed before the device can be legally marketed in India.
Under
the ๐๐๐๐ข๐๐๐ฅ ๐๐๐ฏ๐ข๐๐๐ฌ ๐๐ฎ๐ฅ๐๐ฌ, 2017 (๐๐๐ 2017), medical devices are regulated
according to their risk classification. CDSCO states that all medical devices
are regulated under MDR 2017, with the licensing regime applying to medical
devices other than ๐๐ฅ๐๐ฌ๐ฌ ๐ ๐ง๐จ๐ง-๐ฌ๐ญ๐๐ซ๐ข๐ฅ๐ ๐๐ง๐ ๐ง๐จ๐ง-๐ฆ๐๐๐ฌ๐ฎ๐ซ๐ข๐ง๐ ๐๐๐ฏ๐ข๐๐๐ฌ, which
are exempt from licensing under the applicable notification.
Understanding
CDSCO Medical Device Registration & Licensing
The
๐๐๐ง๐ญ๐ซ๐๐ฅ
๐๐ซ๐ฎ๐ ๐ฌ ๐๐ญ๐๐ง๐๐๐ซ๐ ๐๐จ๐ง๐ญ๐ซ๐จ๐ฅ ๐๐ซ๐ ๐๐ง๐ข๐ฌ๐๐ญ๐ข๐จ๐ง (๐๐๐๐๐) is India's national
regulatory authority for medical devices. India's regulatory framework covers
the import, manufacture, distribution and sale of medical devices under the
Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017.
It
is important to note that the terminology โ๐๐๐๐๐
๐ซ๐๐ ๐ข๐ฌ๐ญ๐ซ๐๐ญ๐ข๐จ๐งโ can be misleading because, depending on the
device and activity, the applicable regulatory requirement may be a ๐ฅ๐ข๐๐๐ง๐๐,
๐ซ๐๐ ๐ข๐ฌ๐ญ๐ซ๐๐ญ๐ข๐จ๐ง ๐จ๐ ๐ฉ๐ซ๐๐ฆ๐ข๐ฌ๐๐ฌ, ๐๐ฅ๐๐ฌ๐ฌ๐ข๐๐ข๐๐๐ญ๐ข๐จ๐ง, ๐ญ๐๐ฌ๐ญ๐ข๐ง๐ , ๐จ๐ซ ๐๐ง๐จ๐ญ๐ก๐๐ซ
๐๐ฉ๐ฉ๐ซ๐จ๐ฏ๐๐ฅ/๐ฉ๐๐ซ๐ฆ๐ข๐ฌ๐ฌ๐ข๐จ๐ง.
CDSCO's
current medical-device resources provide application pathways and checklists
for forms including ๐๐-7, ๐๐-8, ๐๐-14, ๐๐-15, ๐๐-16, ๐๐-22
๐๐ง๐ ๐๐-26, depending on the applicable activity and device.
Medical
Device Risk Classification in India
Medical
devices are classified according to the associated risk:
๐๐ฅ๐๐ฌ๐ฌ ๐ โ Low risk
๐๐ฅ๐๐ฌ๐ฌ ๐ โ Low-moderate risk
๐๐ฅ๐๐ฌ๐ฌ ๐ โ Moderate-high risk
๐๐ฅ๐๐ฌ๐ฌ ๐ โ High risk
This
risk-based framework determines the regulatory requirements applicable to the
device.
For
example, CDSCO has stated that ๐๐ฅ๐๐ฌ๐ฌ ๐ ๐ง๐จ๐ง-๐ฌ๐ญ๐๐ซ๐ข๐ฅ๐ ๐๐ง๐ ๐ง๐จ๐ง-๐ฆ๐๐๐ฌ๐ฎ๐ซ๐ข๐ง๐ ๐ฆ๐๐๐ข๐๐๐ฅ
๐๐๐ฏ๐ข๐๐๐ฌ ๐๐ซ๐ ๐๐ฑ๐๐ฆ๐ฉ๐ญ ๐๐ซ๐จ๐ฆ ๐ญ๐ก๐ ๐ฅ๐ข๐๐๐ง๐ฌ๐ข๐ง๐ ๐ซ๐๐ ๐ข๐ฆ๐, while the
applicable licensing requirements apply to other regulated devices. CDSCO also
records that regulation of all Class A and B medical devices under the
licensing regime commenced from 1 ๐๐๐ญ๐จ๐๐๐ซ 2022,
subject to the applicable exemptions.
Does
Your Medical Device Require CDSCO Approval?
The
answer depends on several factors, including:
1. ๐๐ก๐๐ญ ๐ข๐ฌ ๐ญ๐ก๐ ๐ฉ๐ซ๐จ๐๐ฎ๐๐ญ?
The intended purpose and functionality of the product need to be assessed.
2. ๐๐ฌ ๐ข๐ญ ๐๐ฅ๐๐ฌ๐ฌ๐ข๐๐ข๐๐ ๐๐ฌ ๐ ๐ฆ๐๐๐ข๐๐๐ฅ
๐๐๐ฏ๐ข๐๐ ๐จ๐ซ ๐๐๐?
The regulatory pathway differs depending on the nature and intended use of the
product.
3. ๐๐ก๐๐ญ ๐ข๐ฌ ๐ข๐ญ๐ฌ ๐ซ๐ข๐ฌ๐ค ๐๐ฅ๐๐ฌ๐ฌ๐ข๐๐ข๐๐๐ญ๐ข๐จ๐ง?
The Class A, B, C or D classification can determine the applicable licensing
pathway.
4. ๐๐ซ๐ ๐ฒ๐จ๐ฎ ๐ข๐ฆ๐ฉ๐จ๐ซ๐ญ๐ข๐ง๐ ๐จ๐ซ ๐ฆ๐๐ง๐ฎ๐๐๐๐ญ๐ฎ๐ซ๐ข๐ง๐ ?
Import and domestic manufacturing have different application and compliance
requirements.
5. ๐๐จ๐๐ฌ ๐ญ๐ก๐ ๐ฉ๐ซ๐จ๐๐ฎ๐๐ญ ๐ก๐๐ฏ๐ ๐ ๐ฉ๐ซ๐๐๐ข๐๐๐ญ๐
๐๐๐ฏ๐ข๐๐?
The regulatory pathway may differ depending on whether an appropriate predicate
exists.
6. ๐๐ก๐๐ญ ๐ญ๐๐ฌ๐ญ๐ข๐ง๐ ๐๐ง๐ ๐ญ๐๐๐ก๐ง๐ข๐๐๐ฅ
๐๐จ๐๐ฎ๐ฆ๐๐ง๐ญ๐๐ญ๐ข๐จ๐ง ๐๐ซ๐ ๐ซ๐๐ช๐ฎ๐ข๐ซ๐๐?
Depending on the device, technical documentation, performance information, test
reports and other supporting documents may be required.
CDSCO
Medical Device Compliance Support by ACPL
๐๐๐๐ซ๐๐๐ข๐ญ๐๐ ๐๐จ๐ง๐ฌ๐ฎ๐ฅ๐ญ๐๐ง๐ญ๐ฌ ๐๐ฏ๐ญ. ๐๐ญ๐.
(๐๐๐๐) provides
end-to-end regulatory and compliance support for medical devices and IVDs in
India.
Our
services can include:
Medical device
regulatory applicability assessment
Risk
classification support
CDSCO
registration/licensing assistance
Import licence
support
Manufacturing
licence assistance
Technical
documentation review
Regulatory
dossier preparation
Device grouping
assessment
Testing and
evaluation coordination
CDSCO
application support
Query response
and regulatory correspondence
Post-approval
compliance
Post-market
surveillance support
Materiovigilance
assistance
Regulatory gap
assessment
Importing
a Medical Device into India?
For
an overseas manufacturer or Indian importer, regulatory planning should ideally
begin ๐๐๐๐จ๐ซ๐
๐๐จ๐ฆ๐ฆ๐๐ซ๐๐ข๐๐ฅ ๐ข๐ฆ๐ฉ๐จ๐ซ๐ญ๐๐ญ๐ข๐จ๐ง.
The
CDSCO medical-device system provides specific online processes for
medical-device applications, and the current portal includes provisions
relating to risk classification and import-licence applications.
A
typical regulatory roadmap may involve:
๐๐ซ๐จ๐๐ฎ๐๐ญ ๐๐ฌ๐ฌ๐๐ฌ๐ฌ๐ฆ๐๐ง๐ญ โ ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ ๐๐ฅ๐๐ฌ๐ฌ๐ข๐๐ข๐๐๐ญ๐ข๐จ๐ง โ ๐๐จ๐๐ฎ๐ฆ๐๐ง๐ญ๐๐ญ๐ข๐จ๐ง โ ๐๐๐ฌ๐ญ๐ข๐ง๐ /๐๐ฏ๐๐ฅ๐ฎ๐๐ญ๐ข๐จ๐ง โ ๐๐ฉ๐ฉ๐ฅ๐ข๐๐๐ญ๐ข๐จ๐ง โ ๐๐๐๐๐ ๐๐๐ฏ๐ข๐๐ฐ โ ๐๐ฎ๐๐ซ๐ฒ ๐๐๐ฌ๐จ๐ฅ๐ฎ๐ญ๐ข๐จ๐ง โ ๐๐ข๐๐๐ง๐๐/๐๐ฉ๐ฉ๐ซ๐จ๐ฏ๐๐ฅ โ ๐๐ฆ๐ฉ๐จ๐ซ๐ญ/๐๐๐ง๐ฎ๐๐๐๐ญ๐ฎ๐ซ๐ โ ๐๐จ๐ฌ๐ญ-๐๐๐ซ๐ค๐๐ญ ๐๐จ๐ฆ๐ฉ๐ฅ๐ข๐๐ง๐๐
The
exact pathway should be determined based on the device, intended use,
classification, manufacturer/importer structure and applicable requirements.
Why
Choose Accredited Consultants Pvt. Ltd.?
Medical
device regulatory compliance can involve multiple technical and regulatory
requirements. Choosing the correct pathway at the beginning can help reduce
avoidable documentation gaps and regulatory delays.
๐๐๐๐ซ๐๐๐ข๐ญ๐๐ ๐๐จ๐ง๐ฌ๐ฎ๐ฅ๐ญ๐๐ง๐ญ๐ฌ ๐๐ฏ๐ญ. ๐๐ญ๐. supports businesses with a structured
approach to medical-device regulatory compliance, from initial applicability
assessment through licensing and post-market requirements.
Get Your Medical Device Regulatory
Assessment
๐๐จ๐ญ ๐ฌ๐ฎ๐ซ๐ ๐ฐ๐ก๐๐ญ๐ก๐๐ซ ๐ฒ๐จ๐ฎ๐ซ ๐ฆ๐๐๐ข๐๐๐ฅ ๐๐๐ฏ๐ข๐๐
๐ซ๐๐ช๐ฎ๐ข๐ซ๐๐ฌ ๐๐๐๐๐ ๐ซ๐๐ ๐ข๐ฌ๐ญ๐ซ๐๐ญ๐ข๐จ๐ง ๐จ๐ซ ๐ฅ๐ข๐๐๐ง๐ฌ๐ข๐ง๐ ๐ข๐ง ๐๐ง๐๐ข๐?
Share
your ๐ฉ๐ซ๐จ๐๐ฎ๐๐ญ
๐ง๐๐ฆ๐, ๐ข๐ง๐ญ๐๐ง๐๐๐ ๐ฎ๐ฌ๐, ๐ฆ๐๐ง๐ฎ๐๐๐๐ญ๐ฎ๐ซ๐๐ซ ๐๐๐ญ๐๐ข๐ฅ๐ฌ, ๐๐จ๐ฎ๐ง๐ญ๐ซ๐ฒ ๐จ๐ ๐จ๐ซ๐ข๐ ๐ข๐ง ๐๐ง๐ ๐๐ฏ๐๐ข๐ฅ๐๐๐ฅ๐
๐ฉ๐ซ๐จ๐๐ฎ๐๐ญ ๐๐จ๐๐ฎ๐ฆ๐๐ง๐ญ๐๐ญ๐ข๐จ๐ง with Accredited Consultants Pvt. Ltd. Our
regulatory team can assess the applicable pathway and guide you through the
required compliance process.
๐๐๐๐ซ๐๐๐ข๐ญ๐๐ ๐๐จ๐ง๐ฌ๐ฎ๐ฅ๐ญ๐๐ง๐ญ๐ฌ ๐๐ฏ๐ญ. ๐๐ญ๐. โ
๐๐ง๐-๐ญ๐จ-๐๐ง๐ ๐๐๐๐๐ ๐๐๐ ๐ข๐ฌ๐ญ๐ซ๐๐ญ๐ข๐จ๐ง & ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ ๐๐จ๐ฆ๐ฉ๐ฅ๐ข๐๐ง๐๐ ๐๐๐ซ๐ฏ๐ข๐๐๐ฌ ๐๐จ๐ซ ๐๐๐๐ข๐๐๐ฅ
๐๐๐ฏ๐ข๐๐๐ฌ ๐๐ง๐ ๐๐๐๐ฌ ๐ข๐ง ๐๐ง๐๐ข๐.
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more information visit our official website https://acplgroupindia.co.in & https://acplgroupindia.com
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