A brief introduction about Indian Regulatory process and requirement

1. Divya Ganapathy
Founder
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3.  Central Drugs Standard Control Organization (CDSCO) is the
key medical regulatory organization in India
 CDSCO has setup a separate division which is called
Medical Device Division in order to facilitate mattes
related to Notified Medical Devices.
 Central Licensing Approval Authority (CLAA), is a branch of
the CDSCO, will serve as the main regulatory body for
medical devices.
 All medical devices should undergo conformity assessment
procedures to ensure compliance with quality and safety
standards
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4. THE BELOW LIST OF DEVICES REQUIRE REGISTRATION
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5. THE BELOW LIST OF DEVICES REQUIRE REGISTRATION
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6.  For marketing of notified medical devices India, Registration
Certificate in Form-41 and Import License in Form-10 are
required under the Drugs and Cosmetics Rules.
 Following the submission of the Regulatory Dossier, the CDSCO
officials review the documentation and send Query Letters to
the Authorized Indian Agent for clarifications on the
documents submitted.
 Following the successful addressing of the Query Letters, the
Registration Certificate is issued which is valid for a three
year period.
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7.  The time period for Registration of Medical
Devices in India is generally 6-9 months, and if
clinical trials are required then 18 months
 Registration is valid for 3 years and renewal
applications need to be submitted 6 months in
advance of expiry.
 To obtain Import License 4-5 weeks
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Medical Device Registration
Appoint an In Country Representative to interact with the CDSCO on
your behalf
Compile device application (Form 40)
File registration applications with the CDSCO. Pay fees. All documents
must be in English
CDSCO reviews applications and may require a Technical Presentation
CDSCO will issue a Registration Certificate (Form 41), valid for 3 years.
Identify your distributor in India and apply for Import License.
Qualified distributors must hold Forms 20B and 21B/21C.
Obtain Import License (Form 10) from the CDSCO. License is valid for
the length of the Registration Certificate
Import License
9-12months
The CDSCO may choose to audit your submission and request more documents, which will add
time to your approval.

12.  Our Experience with Regulatory Submission
 Faster approach
 Local presence in Delhi (Close to Regulatory
Office)
 Reduce the timeline to reach the market
 Complete one stop solution
 End to End Service which includes Testing, audit
support, certification, training and
documentation.
 Most of the products would take 12-18 months to
get the product registration, Our service is faster
to get the registration with faster approach.
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