In Vitro Diagnostics (IVDs) CDSCO Registration

Get your In Vitro Diagnostics (IVDs) products CDSCO-registered in India with JR Compliance’s expert support. Our team ensures complete regulatory compliance, hassle-free documentation, and end-to-end guidance throughout the registration process. Whether you’re a domestic or international manufacturer, we’ll streamline your CDSCO IVD registration with 100% accuracy and efficiency.
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Service Overview

In Vitro Diagnostics (IVDs) CDSCO registration is a mandatory requirement under Indian law for manufacturers intending to market or sell diagnostic devices. CDSCO categorizes IVDs into different risk classes and mandates compliance with essential safety and performance parameters. JR Compliance simplifies this process by ensuring documentation, classification, and submission are handled efficiently.

‍Challenges of Filing for a Private Limited Company

Complex Procedures
The formation of the private limited company is quite complex as it requires many legal formalities.
Time-Consuming
Sometimes, its exhausting to gather all the necessary papers and fill out all necessary documents.
Share Limit
In a Private Limited Company there is a limit of 200 shareholders, with a restricted limit on share transfers.
Business Commencement
Within 180 days of registering a Private Limited Company, the certificate of commencement of business must be obtained.

‍Challenges of Filing for In Vitro Diagnostics (IVDs) CDSCO Registration

Complex Regulatory Classification Process
IVDs are divided into risk-based categories by CDSCO. Understanding the right classification demands expert knowledge, or it can lead to incorrect documentation, delays, or even rejection. This makes professional assistance crucial to navigate the registration process effectively.
Inadequate Technical Documentation Support
Providing complete technical data, such as safety testing, stability reports, and clinical evidence, is essential. Many manufacturers struggle to compile comprehensive documents as per CDSCO requirements, resulting in delays or queries from the authority.
Constant Regulatory Updates & Changes
CDSCO guidelines are frequently updated to align with global standards. Staying current with these changes and implementing them into your compliance strategy requires continuous monitoring and regulatory awareness.
Long Approval Timelines Without Expert Help
Improper submissions or missing documents often lead to prolonged approval periods. Without expert consultants like JR Compliance, the chances of procedural errors increase, causing major time and cost setbacks for manufacturers.

Advantages Of In Vitro Diagnostics (IVDs) CDSCO Registration

Legal Market Authorization in India
IVD CDSCO registration is legally mandatory. Once obtained, it authorizes your product for sale and distribution across India, offering a stable market base and business growth.
Enhances Product Credibility & Trust
CDSCO registration acts as a mark of product safety and compliance. It boosts the credibility of your IVD device among healthcare professionals, labs, and consumers, increasing its market acceptance.
Promotes Business Expansion Opportunities
With valid CDSCO registration, you can expand your product reach across India. It also builds a foundation for collaborations with healthcare institutions and distribution networks.
Avoids Regulatory Penalties & Rejections
Timely registration ensures your product is not seized or rejected by regulatory authorities. It protects your brand from legal complications and preserves your business integrity.

Service Process

01
Product Classification Check
We determine the right risk class for your IVD product based on CDSCO guidelines to ensure accurate registration procedure.
02
Documents Preparation Support
Our experts help prepare and compile a compliant documents containing technical details, device labeling, performance data, and more.
03
Submission to CDSCO
We assist in submitting your application to CDSCO along with the necessary forms and documents, as per regulatory standards.
04
Query Resolution Handling
If CDSCO raises any queries, we offer prompt support in preparing responses and modifying submissions to avoid further delays.
05
Approval & Certification
Once approved, we ensure you receive the CDSCO registration certificate and keep you informed of its validity and usage.
06
Post-approval Compliance
Our team supports you in maintaining compliance post-registration, including renewal reminders and regulatory updates.
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Service Process

Consultation
We will have a consultation regarding your business vision and requirements to decide on whether the private limited company fits you well.
Documentation
We will help you to do the paperwork involving preparation of the Memorandum of Association and Articles of Association.
Registration
We will then forward all the necessary documents to the Registrar of Companies as required for registration.
Support
We will always be here with you to offer assistance and advice so that you can efficiently run your private limited company.
Compliance:
We will assist you in maintaining a continuing compliance with all legal and regulatory standards.
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Service Process

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We simplify certification processes, ensuring faster approvals and minimal documentation for seamless compliance.

Our experts stay updated with regulatory changes, offering you complete guidance through every certification stage.

Trusted by 10,000+ businesses, we deliver reliable, professional compliance services tailored to your specific certification needs.

We offer personalized end-to-end support, from document preparation to post-certification assistance.

Why Choose JR Compliance?

Service Breakdown

Eligibility

Eligibility

Class A to D IVD products: All IVDs from low to high-risk categories must undergo mandatory CDSCO registration.
Both Indian & foreign brands: Any brand intending to sell IVDs in India must obtain CDSCO approval.
Authorized agents for foreign brands: Foreign manufacturers must appoint an Indian Authorized Representative.
Products not yet marketed in India: If an IVD is new to the Indian market, CDSCO registration is essential before launch.

Documents

Documents

Device master file: Includes detailed technical info like design, testing, manufacturing process, and labeling.
Clinical evidence reports: Proof of product performance and safety, often including data from clinical trials.
Free sale certificate: Issued by the regulatory body of the exporting country to validate product approval.
Authorized representative letter: A document that confirms the appointment of an Indian representative for foreign brands.

Who Needs

Who Needs

Domestic manufacturers: Required for all Indian IVD product manufacturers before marketing the product.
Foreign IVD exporters: Foreign manufacturers must appoint an Authorized Indian Agent for registration.
Distributors/Importers: Importers of IVDs must ensure the product is CDSCO registered before sales.
Hospitals/labs using imported IVDs: Institutions sourcing IVDs must ensure the devices are CDSCO-approved for legal usage.

Creating

Trust-Driven Relationships

JR Compliance is one of the known name for BIS certification, they are well versed with processes and guide client properly.
Kartik Shah
Published on 4 March 2024
We have outsourced the entire BIS certification responsibility of our panels to JR compliance since 2017 and their service so far has been exemplary.
P N Dhawanjewar
Published on 4 March 2024
We have been using JR Compliance services since last 3 years on various BIS related registration & testing of our various IT & electronic products. We really appreciate your full-fledged & excellent support in all respect in this matter.
K Narayanan
Published on 4 March 2024
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FAQ

What is CDSCO registration for IVDs?
CDSCO registration is a mandatory legal requirement for all IVD products marketed in India. It ensures the device meets quality, safety, and performance standards and allows legal distribution across the Indian market.
Who can apply for IVD CDSCO registration?
Both Indian manufacturers and foreign brands (via an Authorized Indian Representative) can apply for registration. Each must follow CDSCO guidelines and submit the required documentation for their IVD devices.
How long does the registration process take?
The timeline may vary from 3 to 6 months, depending on product classification and dossier completeness. Engaging a compliance expert significantly reduces delays and ensures a quicker registration process.
What happens if my IVD isn’t registered?
Selling or importing unregistered IVDs is illegal in India. It may lead to legal penalties, product seizure, or brand blacklisting by regulatory authorities, severely damaging your reputation.
Can JR Compliance help with foreign manufacturers?
Yes, JR Compliance offers full support to foreign manufacturers, from appointing Indian agents to documentation, submission, and post-approval assistance, ensuring seamless CDSCO IVD registration in India.

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