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- CDSCO Consultants knowledge can support businesses through the submission process and CDSCO certification relating to drugs, medical devices, and cosmetics.
- Diligence Certifications has experienced consultants who provide consulting support to classify, prepare documentation, and submit dossiers through the portal and engage in pre and post approval activities to facilitate a faster CDSCO approval.
- When engaging with the CDSCO for approval or requirements, the process involves a classification, documentation, submission via a portal, and potential compliance prior and post approval through the CDSCO process.
- Utilizing an experienced consultant will decrease risks and time in the process for successful procurement of regulatory filings and CDSCO approval.
- Diligence Certifications Consultants will support any client through the CDSCO registration consulting process across India from pharmaceutical, biological, and diagnostic testing processes.
Introduction
In the year 2024, an orthopedic medical device start-up located in Hyderabad contacted Diligence Certifications for assistance in achieving CDSCO registration after two failed attempts to secure registration for their orthopedic implants. The advanced research and development team that the start-up employed misclassified the device as a Class B, as opposed to the proper classification of Class C. Their misclassification of the orthopedic implant led to letters of deficiency from the Central Drugs Standard Control Organization (CDSCO) on multiple occasions. When our consultants began working with the start-up, we accurately classified the device, created an appropriate technical dossier, and worked directly with the licensing authority. After four months, the start-up received their import licence and began distribution in India.
This many not be a unique occurrence in India. Businesses throughout the country—particularly, small and mid-sized pharma or device manufacturers—struggle to comply with the CDSCO approval process. A CDSCO consultant acts as your regulatory partner, and will ultimately produce documentation, ensure you are compliant, and submit your applications to the CDSCO on your behalf.
What is a CDSCO Consultant and Why You Need One
A CDSCO consultant is a domain expert who guides companies through India’s drug and medical-device regulatory framework under the Drugs and Cosmetics Act and Medical Devices Rules (MDR) 2017.
At Diligence Certifications, our regulatory consultants:
- Evaluate your product’s classification (drug, medical device or cosmetic).
- Identify the correct CDSCO registration form (Form 44, MD-14/15/7/8, etc.).
- Prepare comprehensive dossiers including Device Master File (DMF) and Plant Master File (PMF).
- Liaise with authorised Indian agents and submit via the SUGAM portal.
- Manage deficiency responses, renewals and post-approval changes.
Without expert help, even well-established manufacturers risk rejection or months of delay. Our experience shows that regulatory precision is as critical as product quality when entering the Indian market.
The CDSCO Approval Process — Step by Step
1. Product Classification
Determining whether your product is a drug, device, or cosmetic is critical. For devices, the class determines the authority (State Licensing Authority for A/B; CDSCO for C/D). Consultants ensure your classification aligns with the intended use and risk category.
2. Application Preparation
Every submission demands a specific dossier. For instance, devices require a DMF and PMF; drugs need clinical data, stability reports, and bioequivalence documentation. Diligence Certifications uses a detailed pre-submission checklist to prevent missing components.
3. Portal Submission
Applications are filed online through the portal. A consultant manages user creation, digital signatures, document uploads, and deficiency responses.
4. Review & Queries
The CDSCO reviews applications and issues deficiency letters if needed. Consultants track every response window — delays here can reset your entire application timeline.
5. Inspection & Approval
Depending on risk class and product type, CDSCO may inspect facilities or request samples. Once satisfied, it issues the registration certificate or import/manufacturing licence.
6. Post-Approval Compliance
The consultant’s role continues after approval — ensuring renewals, change management, and vigilance reporting remain compliant.
Through each stage, Diligence Certifications acts as your single point of contact, ensuring no procedural step is overlooked.
How the CDSCO Approval Process Works
1. Comprehending the Authority of Regulation
The Central Drugs Standard Control Organization (CDSCO), which operates under the Ministry of Health & Family Welfare, is responsible for regulating the import, manufacture and sale of drugs, medical devices and cosmetics in India (cdsco.gov.in).
For medical devices, the Medical Devices Rules, 2017 (MDR 2017) establishes a system of classifying medical devices by risk—
Class A and B: Low to moderate risk, typically approved by State Licensing Authorities.
Class C and D: Higher risk requires central review by the CDSCO.
For medicines, all new medicines, vaccines, and fixed-dose combinations require CDSCO approval prior to being marketed in India.
2. Primary Steps to Register with CDSCO
Generally, the steps are:
- Product classification and determination of regulatory pathways.
- Preparation of technical documentation (DMF, PMF, safety data, clinical evaluation, risk analysis).
- Registration on the technical portal and submission of online form.
- Review of documents by CDSCO officials and deficiency queries.
- Issuance of approval/license/registration certificate.
From submission to receipt of approval may take 6 to 18 months, depending upon the complexity of the product, class and if the product has had international approvals prior in other countries.
3. Functions of Consultants in the Process of CDCSO application
A CDSCO consultant like Diligence Certifications ensures that all documentation is aligned to Indian regulatory expectations, clarifies any questions or queries the CDSCO may have in a timely manner, and maintains clear and transparent communication with government authorities— all resulting in speeding your time to approval.
Choosing the Right CDSCO Consultant
The Indian regulatory ecosystem is technical and rapidly evolving. Selecting the right consultant can determine whether your product launches in six months—or sixteen.
1. Proven Track Record
Always verify if your consultant has handled CDSCO registration for products similar to yours. At Diligence Certifications, our consultants have managed approvals for everything from surgical disposables and orthopaedic implants to cosmetics and nutraceuticals.
2. Technical Mastery
The consultant must understand classification rules, risk documentation, and required testing protocols. An incorrect classification can set you back months.
3. Local Regulatory Insight
Since most applications require an authorised Indian agent and physical inspections, your consultant must know how to coordinate between importers, testing labs, and CDSCO.
4. Documentation Strength
Your dossier is the backbone of the approval process. Diligence Certifications employs in-house regulatory writers and subject-matter experts to prepare compliant DMFs and PMFs—reducing the chance of deficiency letters.
5. Post-Approval Compliance
Approvals aren’t the end. Renewals, variation filings, and vigilance reports are equally critical. Our consulting support continues beyond the initial licence issuance.
6. Transparency & Communication
The best consultants communicate timelines, fees, and regulatory risks upfront. Clients often appreciate that Diligence Certifications provides milestone-based project tracking for every CDSCO filing.
Key Services Offered by Diligence Certifications (Your CDSCO Consultant Partner)
- CDSCO Certification & Registration – For drugs, devices, cosmetics and nutraceuticals.
- Regulatory Strategy & Classification – Detailed regulatory roadmap to identify required forms, risk class, and applicable standards.
- Technical Dossier Preparation – Device Master File, Plant Master File, Clinical Evaluation Reports.
- SUGAM Portal Support – Account creation, document upload, and query resolution.
- Post-Approval Maintenance – Renewals, import licence extensions, variations, and vigilance.
- Regulatory Training & Audit Readiness – Internal team training to maintain compliance consistency.
Diligence Certifications acts as your single-window partner for CDSCO registration, BIS certification, and ISO 13485 compliance.
Common Challenges Businesses Face Without a Consultant
- Misclassification of Products:
A simple classification error can shift your approval timeline by months. Consultants prevent this by mapping your device’s intended use to CDSCO’s notified list. - Incomplete Dossiers:
Missing certificates (like ISO 13485 or Free Sale Certificates) or unverified test data frequently result in deficiency letters. - Unclear Response Timelines:
Many companies fail to meet 30-day response deadlines for CDSCO queries, leading to automatic application closure. - Local Representation Issues:
Foreign manufacturers without an Indian authorised agent cannot submit directly — a consultant coordinates this legally. - Post-Approval Neglect:
Renewals, amendments, and adverse event reporting are often overlooked. Experienced consultants maintain long-term compliance schedules.
How Diligence Certifications Delivers Results
A leading cosmetic brand from Mumbai needed CDSCO registration for its new range of imported serums. The importer struggled with ingredient classification under Schedule S. Our consultants reviewed the INCI list, coordinated with the testing laboratory, and prepared the complete dossier. Within three months, the brand received its cosmetic import registration. Today, it sells through 2,000+ retail outlets across India.
Another client, a diagnostic-kit manufacturer from Bengaluru, obtained a CDSCO import licence for a Class B IVD kit within ten months—three months ahead of competitors—thanks to proactive query resolution managed by our team.
Why Choose Diligence Certifications as Your CDSCO Consultant
At Diligence Certifications, we combine deep regulatory expertise with practical industry experience. Our clients include pharmaceutical manufacturers, hospital equipment suppliers, and international exporters entering India.
What sets us apart:
- In-house regulatory team with pharmacology, biotechnology, and biomedical backgrounds.
- Direct coordination with Indian testing labs and notified bodies.
- End-to-end consulting—from CDSCO approval to BIS certification and ISO auditing.
- Proven track record of on-time approvals and transparent documentation handling.
When you partner with us, you don’t just hire a consultant—you gain a regulatory ally who ensures compliance doesn’t delay your business.
Conclusion
Understanding the Indian regulatory environment requires both technical knowledge and procedural experience. A CDSCO consultant is the key to translating the regulatory language into actionable items.
At Diligence Certifications, we take pride in helping manufacturers, importers, and innovators navigate each step of CDSCO registration, certification, and post-approval compliance. If your organization is considering introducing a new drug, device, or cosmetic to the Indian market, contact our regulatory experts today.
Choose Diligence Certifications as your CDSCO consultant to help you navigate India’s evolving compliance process.
Frequently Asked Questions
What is a CDSCO consultant?
A CDSCO consultant helps deal with the registration and approval process for drugs, devices, and cosmetics in India.
Why do I need a CDSCO consultant?
To guarantee accurate classifying, documentation, and speeding up the CDSCO approval process.
How long does CDSCO registration take?
Anywhere from 6-18 months depending on the product type and documentation.
Does Diligence Certifications work with companies outside of India?
Yes, they assist end-users and manufacturers outside of India to enter the Indian market.
What documents are required for CDSCO clearance?
DMF, PMF, ISO 13485, Free Sale Certificate, and test reports.
Can a consultant help me with post-approval compliance?
Yes, they help with renewals, variations, and ongoing reporting responsibilities.
What industries require CDSCO registration?
Any pharma, medical devices, cosmetics, and diagnostics.
How can a CDSCO consultant quickly get approval?
They prepare an accurate dossier and ensure a timely response to CDSCO.
Why go with Diligence Certifications?
They provide full end to end consulting for CDSCO clearance with historical success in many industries.
