Frequently Asked Questions (FAQs)

CDSCO issues several types of licenses, including:

• Manufacturing license required to produce drugs
• Loan license required to manufacture drugs using another company’s facilities
• Test license required to manufacture or import drugs for testing, analysis, or clinical trials
• Import license required to bring drugs into India

Form 25 is required to manufacture non-biological drugs and Form 28 is required to manufacture biological drugs.

A loan license (Form 25A) is granted to a company that does not own manufacturing premises but wishes to manufacture drugs using another licensed manufacturer’s facilities. A loan license allows small companies to produce their products without making a substantial initial investment.

A test license (Form 29) permits the manufacture or import of small quantities of drugs for purposes such as testing, analysis, or clinical trials. It is not for commercial sale.

Manufacturing drugs without a valid license is a violation of the Drugs and Cosmetics Act and can lead to penalties, suspension of operations, product seizure, and prosecution.

Applicants must submit:

• Application form
• Details of premises and equipment
• Land Registration Certificate
• Partnership Deed / Article of Association
• Owner’s ID Proof
• Proof of compliance with GMP (Schedule M)
• Qualified technical staff (pharmacists, chemists) documents
• Fees as prescribed under the Drugs and Cosmetics Rules
• Fire NOC
• Pollution NOC
• Layouts

The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority responsible for approving, licensing, and monitoring medical devices, drugs, and cosmetics.

Devices are classified into Class A, B, C, and D based on risk:

• Class A: Low risk
• Class B: Low–moderate risk
• Class C: Moderate–high risk
• Class D: High risk

All Class A, B, C, and D devices require a CDSCO manufacturing or import license. However, Class A non-measuring, non-sterile devices require only registration and not a license.

• Registration: For low-risk devices (e.g., Class A non-measuring, non-sterile). Requires submission of basic product and manufacturer details.
• License: For higher-risk devices (Class A sterile/measuring, Class B, C, D). Requires detailed technical documentation, QMS compliance, and CDSCO approval.

Class A sterile/measuring and Class B require MD 5 license.

Class C and D require MD 9 license.

Class A sterile/measuring, Class B, C, and D require MD 15 license. However, Class A non-measuring, non-sterile only requires a registration and not an import license.

No, you do not need a CDSCO manufacturing and import license for Class A non-measuring, non-sterile devices. You only required a CDSCO class A registration.

Manufacturing licenses are issued by the State Licensing Authority (SLA) for Class A and B devices, and by the Central Licensing Authority (CLA) for Class C and D devices.

• MD-5 (Class A/B manufacturing): Rs. 5,000 per site + Rs. 500 per device
• MD-9 (Class C/D manufacturing): Rs. 50,000 per site + Rs. 1,000 per device

• Class A (sterile/measuring): $1000 (site) + $50 (each distinct device).
• Class B: $2000 (site) + $1000 (each distinct device).
• Class C/D: $3000 (site) + $1500 (each distinct device).

• Covering Letter
• Company Constitution
• Premises Ownership Proof
• Plant Master File
• Device master file
• Essential Principles Checklist
• Risk Management File
• ISO 13485 (for quality management system)
• Inspection / Audit Report
• Payment Receipt (Challan)
• Layout of premises
• Test License on Form MD13

• Covering Letter
• Power of Attorney notorised by first class magistrate of India or appostiled
• Company Constitution
• Premises Ownership Proof
• Plant Master File
• Device master filefrom foreign manufacturer
• Free sale certificatefrom the country of origin is required. This is required to certify the product is freely sold and legally marketed in its country of origin.
• Essential Principles Checklist
• Risk Management File
• ISO 13485 (for quality management system) 
• Payment Receipt (Challan)

COS-8 is the CDSCO cosmetics manufacturing license for manufacturing cosmetics in India.

COS-2 is the CDSCO cosmetics import license for importing cosmetics into India.

Yes, through a loan license. The applicant must apply for a loan license to manufacture cosmetics using another licensed manufacturer’s premises.

Licenses are typically valid for five years, subject to compliance and payment of renewal fees.

MoCRA stands for Modernization of Cosmetics Regulation Act of 2022. It aims to strengthen the regulatory oversight for cosmetic products, facilities, and companies.

The primary MoCRA requirements are cosmetics facility registration, cosmetics product listing, safety substantiation, cosmetics labelling requirements, cosmetics good manufacturing practices, and adverse event reporting. Compliance with these requirements is essential to make your cosmetics product MoCRA-compliant.

Small businesses whose average gross annual cosmetic products sale for the previous 3 years is less than USD 1 Million are exempt from MoCRA requirements. To be eligible for the exemption, the business should not be involved in manufacturing/processing cosmetic products that can be injected. Additionally, the products should not alter appearance for more than 24 hours without consumer removal. Furthermore, they should not be intended for internal use. Moreover, they should not come into contact with the eye’s mucus membrane.

A 510(k) submission is a premarket notification to the FDA showing that a new medical device is substantially equivalent to a legally marketed predicate device.

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Most Class II devices and some Class I devices require a 510(k). However, Class III devices typically need Premarket Approval (PMA) instead.

It means the new device has the same intended use and similar technological characteristics as a predicate device, or differences do not raise new safety/effectiveness concerns.

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A predicate device is a legally marketed device in the US that serves as the comparison point for demonstrating substantial equivalence.

Some common reasons FDA can place a 510(k) submission on hold are as follows missing sections in the submission, inadequate predicate comparison, insufficient test data, and labeling inconsistencies.

The US FDA Premarket Approval (PMA) is the most stringent regulatory pathway. It is required for Class III high‑risk medical devices, where manufacturers must provide full scientific and clinical evidence to demonstrate safety and effectiveness before marketing.

The major difference between 510(k) and PMA is

• 510(k) is applicable to moderate-risk devices. It is based on predicate comparison.
• PMA is applicable to high-risk Class III devices. It requires full clinical evidence.

The US FDA de novo pathway is intended for novel, low‑ to moderate‑risk devices that have no suitable predicate. It allows FDA to classify them into Class I or II with appropriate controls instead of requiring PMA.

Yes. Many software as a medical device (SaMD) products are cleared via 510(k), provided they demonstrate substantial equivalence.

FDA maintains a public 510(k) database listing all cleared devices. The database is searchable by product code, applicant, or clearance number.

Yes. We prepare detailed project reports (DPRs) with technical and financial feasibility analysis.

Yes. We help align pharma facilities with Schedule M.

Yes. We can help secure CDSCO drug manufacturing license in a hassle-free manner.

Yes. We can help you easily secure the WHO-GMP certification as well as conduct gap analysis, and provide corrective actions to secure the certification in a hassle-free manner.

Yes. We facilitate loan licenses for pharma manufacturing partnerships.

Yes. We can help you obtain CDSCO drug test license for R&D and testing.

Yes. We cover CDSCO medical device licenses for all classes from MD5 (Class A & B devices) and MD9 (Class C & D devices) to MD15 (import license) and MD13 (test license).

We prepare DMFs and PMFs as part of regulatory submissions.

Yes. We assist with US FDA 510(k) submissions for device approvals.

Yes. We provide support for easily securing the CE marking under EU MDR.

Yes. We help with Health Canada medical device licensing (MDL/MDEL).

Yes. Preparing detailed project reports (DPRs) for medical device manufacturing units are part of our services.

Yes. We offer comprehensive MDSAP consultation service along with post audit support. 

Yes. As holders of the CDSCO MD42 license, IEC Code, and ISO 13485 certification, we are uniquely positioned to serve as authorized agents.

Yes. We can help you easily navigate the SFDA medical device registration process.

Yes. We can help you easily secure the CDSCO cosmetics manufacturing license (COS-8).

Yes. We can help you easily secure the CDSCO cosmetics import license (COS-2).

Yes. We help align cosmetics products with US FDA MoCRA guidelines.

Yes. We prepare detailed project reports for cosmetics plants along with technical and financial feasibility and compliance analysis.

Yes. We can help you align your cosmetics products with the CDSCO cosmetics labelling and FDA cosmetics labelling guidelines.

Yes. We provide comprehensive plant setup services for pharmaceuticals, medical devices, cosmetics, nutraceuticals, and homeopathy plants. This includes factory layout planning, AutoCAD drawings, HVAC design, and compliance with CDSCO, FDA, and WHO-GMP standards.

We design civil, electrical, plumbing, HVAC, epoxy flooring, and false ceiling layouts. Our layouts ensure smooth operations and regulatory compliance.

We understand that the right machinery is pivotal for optimal production. We guide our clients to invest in machinery that maximizes output, ensures quality, and offers long-term reliability. Additionally, we help optimize placement for efficiency and compliance.

We assist with Form 25 (non-biological drugs) and Form 28 (biological drugs) CDSCO drug manufacturing licensing.

Yes. We can help you obtain all types of CDSCO medical device licenses. Our service covers MD5 (Class A & B devices), MD9 (Class C & D devices), MD15 (import license), Loan license, and MD13 (test license).

Yes. We can help you obtain all types of CDSCO IVD license, namely MD5 (Class A & B devices), MD9 (Class C & D devices), and MD15 (import license).

Yes. We provide support for COS-8 and COS-2 licenses for cosmetics manufacturing and import.

Yes. We help obtain CDSCO licenses for nutraceuticals and health supplements.

Yes. We assist with Form 25C licensing for homeopathy manufacturing units in India.

Yes. We create complete ISO 13485 QMS documentation, including SOPs, manuals, and validation protocols.

Yes. We prepare dossiers and compliance documents as per Schedule M and WHO-GMP guidelines.

Yes. We draft customized SOPs for pharma, medical devices, and cosmetics facilities.

Yes. We prepare process validation, equipment validation, and cleaning validation documents.

Yes. We deliver targeted training for regulatory compliance.

Yes. We conduct mock audits for pharma, medical device, and cosmetic facilities. Our mock audits aim to identify non-compliance and provide actionable next steps to address these shortcomings.

Yes. We design efficient and robust corrective and preventive action (CAPA) systems.

Yes. We help implement ISO 14971 risk management frameworks.

We can help you easily get GMP, GLP, WHO-GMP, COPP, ISO 9001, and ISO 13485 certifications.

Yes. We assist in obtaining Free Sale Certificates from CDSCO for exports.

Yes. We will help companies easily secure ISO certifications by preparing the application and necessary documentations. Additionally, we conduct mock audits to help identify gaps.

Yes. COPP certification is part of our services for international market entry.

Yes. Our team of experts can help you easily secure the Neutral Code.

Yes. Our certification service covers Performance Certificate.

Yes. We can help you easily secure the Market Standing Certificate.