13/03/2026
Medical Device and IVD Registration
๐๐๐๐ข๐๐๐ฅ ๐๐๐ฏ๐ข๐๐ ๐๐ง๐ ๐๐๐ ๐๐๐ ๐ข๐ฌ๐ญ๐ซ๐๐ญ๐ข๐จ๐ง
๐๐ฒ ๐๐๐๐ซ๐๐๐ข๐ญ๐๐ ๐๐จ๐ง๐ฌ๐ฎ๐ฅ๐ญ๐๐ง๐ญ๐ฌ ๐๐ฏ๐ญ. ๐๐ญ๐.
The medical device and in-vitro
diagnostic (IVD) industry is one of the fastest-growing healthcare sectors in
India. With the increasing demand for advanced diagnostic equipment, medical
instruments, and healthcare technologies, regulatory compliance has become
essential for manufacturers, importers, and distributors. Medical devices and
IVD products must obtain proper regulatory approval before being manufactured,
imported, or marketed in India.
In India, the regulation of medical
devices and IVD products is governed by the ๐๐๐๐ข๐๐๐ฅ ๐๐๐ฏ๐ข๐๐๐ฌ ๐๐ฎ๐ฅ๐๐ฌ, 2017
under the ๐๐ซ๐ฎ๐ ๐ฌ ๐๐ง๐ ๐๐จ๐ฌ๐ฆ๐๐ญ๐ข๐๐ฌ ๐๐๐ญ, 1940. The regulatory authority
responsible for approving and monitoring these products is the Central Drugs
Standard Control Organization, which functions under the Ministry of Health and
Family Welfare.
Accredited Consultants Pvt. Ltd.
(ACPL) provides professional support for medical device and IVD registration,
helping companies navigate complex regulatory procedures and obtain approvals
efficiently.
๐๐๐๐ข๐๐๐ฅ
๐๐๐ฏ๐ข๐๐๐ฌ ๐๐ง๐ ๐๐๐๐ฌ
Medical devices are instruments,
machines, implants, or software intended for medical purposes such as
diagnosis, treatment, monitoring, or prevention of diseases. Examples include
surgical instruments, patient monitoring equipment, implants, and diagnostic
devices.
In-vitro diagnostic devices (IVDs)
are medical devices used to perform tests on samples such as blood, urine, or
tissue outside the human body. These tests help detect diseases, infections,
and medical conditions.
Examples of IVDs include:
Blood glucose testing kits
COVID-19 test kits
Pregnancy test kits
Diagnostic reagents
Laboratory testing equipment
๐๐๐๐ข๐๐๐ฅ
๐๐๐ฏ๐ข๐๐ ๐๐ฅ๐๐ฌ๐ฌ๐ข๐๐ข๐๐๐ญ๐ข๐จ๐ง ๐ข๐ง ๐๐ง๐๐ข๐
Medical devices in India are
classified based on their risk level:
๐๐ฅ๐๐ฌ๐ฌ ๐
โ Low risk devices (e.g., surgical dressings, thermometers)
๐๐ฅ๐๐ฌ๐ฌ ๐
โ Low to moderate risk devices
๐๐ฅ๐๐ฌ๐ฌ ๐
โ Moderate to high risk devices
๐๐ฅ๐๐ฌ๐ฌ ๐
โ High risk devices (e.g., heart valves, critical diagnostic devices)
The regulatory approval process
depends on the classification of the device.
๐๐ฒ๐ฉ๐๐ฌ
๐จ๐ ๐๐๐๐ข๐๐๐ฅ ๐๐๐ฏ๐ข๐๐ ๐๐๐ ๐ข๐ฌ๐ญ๐ซ๐๐ญ๐ข๐จ๐ง๐ฌ
Businesses dealing with medical
devices or IVD products may require different types of licenses depending on
their activities.
๐๐๐ง๐ฎ๐๐๐๐ญ๐ฎ๐ซ๐ข๐ง๐
๐๐ข๐๐๐ง๐ฌ๐
Companies that manufacture medical
devices in India must obtain a manufacturing license from the relevant
authority.
๐๐ฆ๐ฉ๐จ๐ซ๐ญ
๐๐ข๐๐๐ง๐ฌ๐
Companies importing medical devices
into India must obtain an import license from CDSCO.
๐๐จ๐๐ง
๐๐ข๐๐๐ง๐ฌ๐
A loan license allows companies to
manufacture medical devices using the facilities of another licensed
manufacturer.
๐๐จ๐๐ฎ๐ฆ๐๐ง๐ญ๐ฌ
๐๐๐ช๐ฎ๐ข๐ซ๐๐ ๐๐จ๐ซ ๐๐๐ ๐ข๐ฌ๐ญ๐ซ๐๐ญ๐ข๐จ๐ง
To obtain medical device or IVD
registration, the following documents are generally required:
Application form and covering letter
Device master file
Plant master file (for manufacturing units)
Free Sale Certificate from the country of origin
ISO certification
Product testing reports
Labeling and packaging details
Authorized agent agreement (for imported devices)
Accurate documentation is essential
to avoid delays or regulatory queries.
๐๐๐๐ข๐๐๐ฅ
๐๐๐ฏ๐ข๐๐ ๐๐๐ ๐ข๐ฌ๐ญ๐ซ๐๐ญ๐ข๐จ๐ง ๐๐ซ๐จ๐๐๐ฌ๐ฌ
The registration process typically
involves the following steps:
๐๐ญ๐๐ฉ
1 โ ๐๐ซ๐จ๐๐ฎ๐๐ญ ๐๐ฅ๐๐ฌ๐ฌ๐ข๐๐ข๐๐๐ญ๐ข๐จ๐ง
Determining the correct
classification of the medical device according to regulatory guidelines.
๐๐ญ๐๐ฉ
2 โ ๐๐จ๐๐ฎ๐ฆ๐๐ง๐ญ๐๐ญ๐ข๐จ๐ง ๐๐ซ๐๐ฉ๐๐ซ๐๐ญ๐ข๐จ๐ง
Preparation of technical documents,
safety reports, and regulatory certificates.
๐๐ญ๐๐ฉ
3 โ ๐๐ฉ๐ฉ๐ฅ๐ข๐๐๐ญ๐ข๐จ๐ง ๐๐ฎ๐๐ฆ๐ข๐ฌ๐ฌ๐ข๐จ๐ง
Submission of the registration
application through the CDSCO online portal.
๐๐ญ๐๐ฉ
4 โ ๐๐๐ฏ๐ข๐๐ฐ ๐๐ง๐ ๐๐ฏ๐๐ฅ๐ฎ๐๐ญ๐ข๐จ๐ง
Regulatory authorities review the
submitted documents and may raise queries.
๐๐ญ๐๐ฉ
5 โ ๐๐ฉ๐ฉ๐ซ๐จ๐ฏ๐๐ฅ ๐๐ง๐ ๐๐ข๐๐๐ง๐ฌ๐ ๐๐ฌ๐ฌ๐ฎ๐๐ง๐๐
After successful evaluation, the
license or registration certificate is issued.
๐๐ก๐๐ฅ๐ฅ๐๐ง๐ ๐๐ฌ
๐ข๐ง ๐๐๐๐ข๐๐๐ฅ ๐๐๐ฏ๐ข๐๐ ๐๐๐ ๐ข๐ฌ๐ญ๐ซ๐๐ญ๐ข๐จ๐ง
Companies often face challenges
during the registration process due to:
Complex technical documentation requirements
Device classification confusion
Regulatory updates and compliance changes
Delay in responding to regulatory queries
Professional regulatory support can
significantly reduce these challenges.
๐๐๐๐ซ๐๐๐ข๐ญ๐๐
๐๐จ๐ง๐ฌ๐ฎ๐ฅ๐ญ๐๐ง๐ญ๐ฌ ๐๐ฏ๐ญ. ๐๐ญ๐. ๐๐๐ง ๐๐๐ฅ๐ฉ
Accredited Consultants Pvt. Ltd. is
a trusted regulatory consulting firm specializing in pharmaceutical, cosmetic,
and medical device regulatory services. The company assists manufacturers and
importers in obtaining medical device and IVD registrations efficiently.
๐๐ฎ๐ซ
๐๐๐ซ๐ฏ๐ข๐๐๐ฌ ๐๐ง๐๐ฅ๐ฎ๐๐:
Medical device classification and regulatory strategy
Documentation preparation and technical file review
Import and manufacturing license applications
CDSCO portal submission and tracking
Regulatory query response management
Compliance advisory and regulatory updates
Our team ensures that all
applications meet regulatory standards and are submitted accurately.
๐๐๐ง๐๐๐ข๐ญ๐ฌ
๐จ๐ ๐๐ก๐จ๐จ๐ฌ๐ข๐ง๐ ๐๐๐๐ซ๐๐๐ข๐ญ๐๐ ๐๐จ๐ง๐ฌ๐ฎ๐ฅ๐ญ๐๐ง๐ญ๐ฌ ๐๐ฏ๐ญ. ๐๐ญ๐.
Working with ACPL offers several
advantages:
Expert regulatory guidance
Faster and smoother approval process
Accurate documentation preparation
Reduced compliance risks
End-to-end regulatory support
Our goal is to help companies launch
medical devices and diagnostic products in the Indian market with confidence.
Bottom of Form
For more information visit our
official website ๐ก๐ญ๐ญ๐ฉ๐ฌ://๐๐๐ฉ๐ฅ๐ ๐ซ๐จ๐ฎ๐ฉ๐ข๐ง๐๐ข๐.๐๐จ.๐ข๐ง, ๐ก๐ญ๐ญ๐ฉ๐ฌ://๐๐๐ฉ๐ฅ๐ ๐ซ๐จ๐ฎ๐ฉ๐ข๐ง๐๐ข๐.๐๐จ๐ฆ
Email: info@acplgroupindia.co.in
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