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Class A Notified Medical Devices Registration in India
India’s medical device sector is growing at a remarkable pace, which also means greater regulatory oversight to safeguard patient safety and product quality.
In this article, we explain the regulatory pathway for Class A medical device registration in India, including documentation, application process and timelines — in a clear and practical way.
What Are Class A Medical Devices?
Class A devices are classified as low-risk products
that do not sustain or support life and do not lead to a potential high risk
for the user if they fail.
Examples include:
- Surgical
dressings
- Gloves
- Stethoscopes
- Thermometers
- Hospital
bed accessories
- Dental
burs/tips
- Disposable
syringes (non-measuring)
These devices are notified by the Ministry of Health
& Family Welfare and therefore fall under the regulatory control of the Central
Drugs Standard Control Organisation (CDSCO).
Yes.
As per the 5th Amendment of the Medical Device Rules (G.S.R. 754(E), 30 Sept
2022), all Class A and Class B medical devices must be registered
with CDSCO before they can be manufactured, imported, distributed or sold in
India.
Who Can Apply?
|
Applicant Type |
Registration Type |
Authority |
|
Indian Manufacturer |
Form MD-3 → MD-5 Licence |
State Licensing Authority |
|
Importer / Foreign Manufacturer |
Form MD-14 → MD-15 Licence |
CDSCO (Central) |
Documentation
Required (Class A Registration)
- Cover
Letter
- Application
Form (MD-3 or MD-14)
- Device
Master File (DMF)
- Plant
Master File (PMF)
- ISO
13485 Certificate
- Free
Sale Certificate (for imports)
- Labels
& Artwork
- Sterilisation / Biocompatibility Data (if applicable)
Note: For non-sterile / non-measuring devices, a
simplified dossier is sufficient; however, the QMS (ISO 13485) is still
mandatory.
Class A Registration → 30–45 days, if documents are complete and compliant.
At ZYPS Regulatory Compliance, we have helped
numerous manufacturers and importers successfully register their Class A
notified devices with CDSCO – without delays or rejections.
Our support includes:
- Product
classification & gap analysis
- Preparation
of DMF / PMF & Label review
- Online
submission on the Sugam Portal
- Query
handling & liaison with CDSCO
- End-to-end
documentation and approval support
Need support with your Class A Medical Device
Registration?
Contact ZYPS – Your Trusted
Regulatory Partner
+91-9910316549 | info@zypsco.in