CDSCO Registration

Types of Registrations under CDSCO

1. CDSCO Medical Device Registration for Manufacturers
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority responsible for regulating medical devices. Manufacturers intending to produce medical devices in India must register their products under CDSCO to ensure compliance with safety, quality, and performance standards. This process involves classifying devices based on risk, submitting a comprehensive application with product details, manufacturing site information, technical documentation, and quality certifications. Additionally, the manufacturer must adhere to the Medical Devices Rules, 2017, and may be subject to inspections for conformity assessment. Successful registration allows manufacturers to legally produce and market medical devices in India.

2. CDSCO Cosmetic Import Registration
Any individual or company intending to import cosmetics into India must obtain an import registration certificate from CDSCO. This ensures that imported cosmetic products comply with the safety and quality standards set by Indian regulations. The process requires submitting an application in Form 42 along with supporting documents, including the product's ingredients list, labels, and free sale certificates from the country of origin. Additionally, safety data and proof of adherence to Good Manufacturing Practices (GMP) must be provided. Once approved, the registration certificate permits the legal import and sale of cosmetic products in India.

3. CDSCO Medical Device Import License
Importers seeking to bring medical devices into India must secure an Import License under CDSCO. This involves classifying the device based on its risk category and submitting an application through the SUGAM portal. Essential documentation includes product details, manufacturing site information, regulatory certificates from the country of origin, and a quality management system certification. The CDSCO may conduct site inspections to verify compliance. Upon successful evaluation, the Import License is granted, authorizing the importer to distribute and sell the medical device within India, ensuring it meets all regulatory standards.

4. Cosmetic Manufacturing License
Manufacturers intending to produce cosmetics in India must obtain a Cosmetic Manufacturing License from the State Drug Control Authority under the Drugs and Cosmetics Act, 1940. The license ensures that the manufacturer adheres to prescribed safety and quality standards. The application process requires submitting details about the manufacturing facility, equipment, skilled personnel, and adherence to Good Manufacturing Practices (GMP). Samples of products and labeling information must also be provided. Periodic inspections ensure compliance, and once the license is granted, it allows the manufacturer to legally produce and market cosmetics in India.

5. In Vitro Diagnostic Device Manufacturing License
In India, manufacturers producing In Vitro Diagnostic (IVD) devices, such as test kits or laboratory instruments, must obtain a manufacturing license from CDSCO. The application process involves submitting detailed information about the product, manufacturing processes, facility layout, and quality control measures. Compliance with the Medical Devices Rules, 2017, is mandatory, including adherence to risk-based classification and quality management standards like ISO 13485. The CDSCO may conduct facility audits to ensure regulatory compliance. Once approved, the license permits the legal manufacturing and distribution of IVD devices in India.

6. In Vitro Diagnostic Device Import License
Importing IVD devices into India requires securing an Import License from CDSCO. Applicants must classify the devices according to risk levels and submit an application via the SUGAM portal. Essential documents include product specifications, certificates of analysis, free sale certificates, and quality certifications from the manufacturing country. Additionally, adherence to ISO 13485 standards must be demonstrated. CDSCO may inspect the manufacturing sites to verify compliance. Upon approval, the license enables the importer to legally distribute IVD devices in India, ensuring safety and regulatory conformity.

7. Drug License
A Drug License is mandatory for any business engaged in the manufacturing, distribution, or sale of pharmaceutical products in India. Issued under the Drugs and Cosmetics Act, 1940, the license ensures that medicines meet quality and safety standards. Depending on the nature of the business, licenses are categorized into manufacturing, wholesale, or retail. The application process requires providing details about premises, storage conditions, technical staff qualifications, and adherence to Good Manufacturing Practices (GMP). Regular inspections are conducted to ensure compliance. Possessing a valid drug license is essential to legally manufacture, distribute, or sell drugs in India.

Eligibility Criteria for CDSCO Registration in India

Eligible applicants who can register on the CDSCO portal include:

1. Importers: Entities involved in importing drugs and cosmetics into India.
2. Indian Agents: Representatives of foreign manufacturers who act on behalf of the principal company in India.
3. Foreign Enterprises Holding Indian Subsidiary: Foreign companies that operate through an Indian subsidiary.
4. Corporates: Large business entities responsible for manufacturing, importing, or exporting drugs and cosmetics.

It is important to note that manufacturing units cannot register directly on the CDSCO portal. Instead, a corporate entity must first create login credentials for the manufacturing unit. Once registered, the manufacturing unit can then access the portal for necessary applications and regulatory procedures.

The registration process with CDSCO can be complex, given the detailed regulatory requirements and compliance standards involved. This is where expert assistance becomes valuable. Compliance Calendar LLP offers comprehensive support for CDSCO registration. With deep expertise in regulatory compliance, our team ensures that your registration process is seamless and compliant with all legal requirements. We assist in documentation, application submission, and liaising with regulatory authorities to help you secure timely approvals.

CDSCO Manufacturing License for Medical Devices in India

The Central Drugs Standard Control Organization (CDSCO) is the regulatory body in India that governs the registration and regulation of medical devices. If you are planning to manufacture medical devices in India, it is mandatory to obtain a CDSCO Manufacturing License. This guide covers everything you need to know about the process, requirements, and documentation for securing a manufacturing license under CDSCO regulations.

CDSCO Medical Device Registration and Licensing

The CDSCO Manufacturing License for Medical Devices falls under the Central Licensing Approval Authority (CLAA) scheme. The license is granted by the State Licensing Authority but is subject to approval by CLAA, provided that the licensee meets all the conditions and requirements specified under the Medical Devices Rules.

Many companies import raw materials, semi-finished products, or components into India. For such businesses, the final assembly and packaging of medical devices in India necessitate a CDSCO Manufacturing License. However, if a fully finished product is manufactured outside India, a CDSCO import license will be required for its sale in the Indian market.

How to Register for CDSCO Manufacturing License for Medical Devices?

To register for a CDSCO Manufacturing License for Medical Devices, companies must follow a detailed procedure that ensures compliance with regulatory requirements. Below are the key steps involved:

1. Determine License Type: Identify the specific type of license based on the class of medical device you intend to manufacture.
2. Meet Eligibility Criteria: Ensure your manufacturing facility complies with Good Manufacturing Practices (GMP) and other eligibility norms.
3. Qualified Technical Staff: Employ qualified professionals who can oversee manufacturing operations and quality control.
4. Prepare Application: Submit an application with all necessary documentation, including Form 27, applicable fees, site master file, premises details, and manufacturing process information.
5. Submit to Authority: Depending on the type of device, the application should be submitted to the respective State Drug Control Department or CDSCO.

Phases of CDSCO Medical Device Manufacturing License Process

Phase I – Applicant Registration for CDSCO Manufacturing License

The first step involves registering the applicant on the CDSCO portal. You will need to generate login credentials by submitting the following documents:

• Address Proof: Certificate of registration, certificate of incorporation, or import-export certificate.
• ID Proof: Identification documents of the authorized person handling registrations.

Once these documents are submitted online, you will receive a preliminary approval mail from CDSCO, followed by a request for submitting hard copies.

Phase II – CDSCO Manufacturing Test License Application

A Test License is required to manufacture a limited quantity of medical devices for testing, evaluation, demonstration, or training purposes. The procedure is as follows:

• Apply online using Form MD-12.
• Upload the necessary documentation.
• Pay the prescribed fees.
• Wait for status updates regarding your application.

Phase III – CDSCO Manufacturing License Application

For commercial manufacturing of medical devices, the process includes:

• Online application submission via CDSCO portal.
• Filling Form MD-3 for Class A & B devices or Form MD-7 for Class C & D devices.
• Upload all required documents.
• Pay the applicable fees.
• Receive an approval or rejection email from CDSCO.

Classification of Medical Devices as per CDSCO

Medical devices in India are classified based on their risk level:

• Class A (Low Risk): Includes stethoscopes, bandages, etc.
• Class B (Low to Moderate Risk): Includes blood pressure monitors, syringes, etc.
• Class C (Moderate to High Risk): Includes orthopedic implants, catheters, etc.
• Class D (High Risk): Includes pacemakers, heart-lung machines, ventilators, etc.

Process to Obtain CDSCO Manufacturing License

1. Device Classification: Determine the risk classification of your medical device.
2. Documentation Preparation: Prepare technical documentation including device description, specifications, and safety data.
3. Application Submission: Submit your application along with technical documents, cover letter, and fees.
4. Review Process: CDSCO will review the documents and may request additional information.
5. Facility Inspection: CDSCO will inspect the manufacturing facility to ensure compliance.
6. License Approval: Upon successful inspection and documentation review, CDSCO will issue the manufacturing license.
7. License Renewal: The license is generally valid for five years and needs timely renewal.

Different CDSCO Forms for Medical Device Registration for Manufacturers

• Form MD-3: Application for manufacturing Class A & B medical devices.
• Form MD-5: License issued for manufacturing Class A & B devices after approval.
• Form MD-7: Application for manufacturing Class C & D medical devices.
• Form MD-9: License issued for manufacturing Class C & D devices after approval.

How to Apply on CDSCO Portal for Manufacturing License?

Here is a detailed guide for applying online on the CDSCO Portal:

1. Registration: Create an account using a valid email ID.
2. Login and Navigate: Access the online application section and select "Medical Devices."
3. Application Form: Fill the form with accurate information about the company, manufacturing process, and quality procedures.
4. Document Upload: Submit required documents including manufacturing plans and product specifications.
5. Payment: Complete the application fee payment using the online gateway.
6. Submission: Submit the application and await review.
7. Approval: Once the application is approved, CDSCO will issue the manufacturing license.

Opportunities in Medical Device Parks in India

India's dedicated medical device parks provide a significant opportunity for manufacturers to set up production units with world-class infrastructure. Establishing a facility in these parks can ease regulatory approvals and help in scaling operations.

Obtaining a CDSCO Manufacturing License for Medical Devices is a detailed but essential process for any medical device manufacturer in India. Compliance with CDSCO regulations ensures that devices are safe, reliable, and ready for market distribution. With proper guidance and adherence to procedures, securing a CDSCO license can be a straightforward process.

For more information on CDSCO Medical Device Registration or assistance with regulatory compliance, feel free to contact our team of experts. For professional support, contact Compliance Calendar via email at info@ccoffice.in or WhatsApp or call +91 9988424211 for expert guidance.

CDSCO Medical Device Import License

Importing medical devices into India involves adhering to the strict guidelines set by the Central Drugs Standard Control Organization (CDSCO). The CDSCO, operating under the Directorate General of Health Services in the Ministry of Health and Family Welfare, issues medical device import licenses, such as the MD 15 license. Ensuring a smooth and efficient import licensing process can be challenging, but expert assistance from experienced consultants like Operon Strategist can streamline this complex journey.

CDSCO Import License for Medical Devices in India

All medical devices imported into India must comply with the Indian Medical Device Regulations established by the CDSCO. This regulatory body oversees the approval and regulation of all medical devices and clinical trials across the country. It establishes quality control measures for imported medical devices and collaborates with State Drug Control Organizations to ensure compliance.

With the latest guidance from CDSCO, importers of medical devices classified as Class A, B, C, or D may face suspension or cancellation of import licenses if they fail to meet the mandatory licensing deadlines. To ensure compliance, importers must classify their devices under the CDSCO classification rule and follow the structured import license procedure. Although manufacturers previously imported and sold medical devices without strict regulations, the 2006 reforms require adherence to specific import guidelines set by CDSCO.

Why Choose Compliance Calendar for Your CDSCO Import License for Medical Devices?

Compliance stands out as a leading CDSCO import license consultant, offering complete support throughout the medical device import license process. With over 12 years of experience and successful completion of various CDSCO registrations, Compliance Calendar is well-equipped to assist with the complexities of regulatory compliance.

From the initial classification of the medical device to preparing and submitting technical documents, Operon Strategist ensures a hassle-free and efficient licensing process. Their in-house technical team is skilled in resolving CDSCO queries, ensuring accurate and timely submissions. Operon Strategist provides complete end-to-end assistance, including:

• Correct classification of medical devices.
• Generation of CDSCO login credentials.
• Preparation and review of technical documentation.
• Guidance for online fee payment and application submission.
• Query resolution and follow-ups with CDSCO.

Pre-Requisites for CDSCO Medical Device Import License

Before applying for a CDSCO Medical Device Import License, it is essential to gather key information about the medical device, including:

• Generic Name / Brand Name.
• Intended Use of the device.
• Material of Construction.
• Mode of Application.
• Detailed classification based on risk factors.

CDSCO Import License Registration Phases for Medical Devices

The CDSCO Important License for Medical Device process involves multiple phases, each with specific requirements to ensure proper documentation and compliance.

Phase I - Applicant Registration

The first step involves registering the applicant on the CDSCO online portal. The applicant, either an authorized distributor or agent with a valid wholesale drug license (Form 20/21B) or registration certificate (Form 41/42), must submit Form MD-14 to the Central Licensing Authority. This step includes:

• Online form submission.
• Submission of required documents.
• Awaiting approval from CDSCO. In case of rejection, the applicant will receive detailed feedback for resubmission.

Phase II - Medical Device Import License Application

This phase involves submitting the detailed import license application, which includes essential information such as:

• Device classification.
• Brand name and product description.
• Intended use and mode of operation.

Applicants must also upload necessary regulatory documents like the European CE Certificate, Free Sale Certificate, ISO 13485, Plant Master File, and Device Master File. Upon successful submission and payment of fees based on the device classification, an application number will be generated for further processing.

Phase III - Application Review by CDSCO

In this phase, CDSCO accurately reviews the submitted application and supporting documents. If any discrepancies are noted, applicants are notified to provide clarifications or submit revised documents. Timely resolution of queries is crucial for avoiding delays.

Phase IV - License Approval

Upon successful verification and resolution of queries, CDSCO grants the medical device import license. The license is valid for five years from the date of issuance, ensuring long-term compliance for the importer.

Obtaining a CDSCO Medical Device Import License is an important step for successfully importing and marketing medical devices in India. With strict regulatory requirements and a detailed approval process, partnering with an experienced consultant like Compliance Calendar can save time, effort, and ensure compliance with Indian regulations. Whether you are importing raw materials, semi-finished goods, or final products, Compliance Calendar provides the necessary guidance and support for successful licensing.

For detailed consultation and expert assistance, contact Compliance Calendar today and simplify your CDSCO Import License process for medical devices in India.

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• Phone: +91 9988424211
• Email: info@ccoffice.in

CDSCO Cosmetic Manufacturing License in India

The cosmetic industry in India is expanding rapidly, influencing markets from television advertisements to social media promotions. With an ever-growing demand for cosmetic products, it is essential for manufacturers to ensure that their operations comply with Indian regulations. The CDSCO Cosmetic Manufacturing License is a crucial requirement for legal manufacturing and sale of cosmetics in India. This guide will walk you through the essential information about obtaining the CDSCO Manufacturing License for Cosmetics in India.

Under Section 3 (aaa) of the Drugs & Cosmetics Act, 1940, a cosmetic is defined as any article intended to be poured, sprayed, rubbed, or introduced into or applied to the human body or any part thereof for beautifying, cleansing, promoting attractiveness, or altering appearance. It also includes any article intended for use as a component of cosmetic. The CDSCO Cosmetic License ensures that these products meet the regulatory standards for safety and quality.

Regulatory Authority for Cosmetic Manufacturing License

The regulation of cosmetic manufacturing in India is carried out by State Licensing Authorities (SLAs) appointed by the State Governments, while the import of cosmetic products is regulated by the Central Licensing Authority (CLA) appointed by the Central Government. The State Licensing Authority is responsible for issuing and renewing cosmetic manufacturing licenses, ensuring that manufacturers comply with the Drugs and Cosmetics Act, 1940, and the rules framed thereunder.

List of Cosmetic Products Regulated Under the License

Cosmetic products regulated under the CDSCO Manufacturing License for Cosmetics include:

• Deodorant soaps

• Hair colorants and setting products

• Lip products

• Skin-whitening products

• Face masks and make-up powders

• Emulsions, creams, lotions, oils, and gels for skin

• Deodorants and antiperspirants

• Hairdressing products like lacquers and lotions

• Products for external intimate hygiene

• Shaving products like creams and foams

• Sunbathing products and depilatories

• Toilet soaps and bath preparations

• Alcoholic fragrance solutions

• Mouth and teeth care products

• After-bath powders and hygienic powders

• Toilet waters, perfumes, and eau de Cologne

Categories of Cosmetics Under Schedule M-II

The Drugs & Cosmetics Rules, 1945, categorize cosmetic products into 11 primary categories under Schedule M-II:

1. Powders

2. Creams, lotions, milk, shampoos, cleansing, pomade, shaving creams, hair oils, etc.

3. Nail polishes and nail lacquers

4. Alcoholic fragrance solutions

5. Hair dyes

6. Lipsticks and lip gloss

7. Depilatories

8. Preparations for eyes

9. Aerosol products

10. Tooth powder and toothpaste

11. Toilet soaps

Regulations for Cosmetic Manufacturing License in India

Before issuing the CDSCO Cosmetic License, the SLA conducts a comprehensive inspection of the manufacturing premises. The inspecting officer submits a detailed report based on which the Licensing Authority decides whether to grant the license. The manufacturer must comply with specific regulations including the following:

Qualification Criteria for Technical Staff:

• Must be registered under the Pharmacy Act, 1948, or;

• Hold a diploma in pharmacy as recognized by the Pharmacy Council of India, or;

• Have passed the intermediate exam with chemistry as one of the subjects, or any other qualification as deemed appropriate by the Licensing Authority.

Labelling Requirements for Cosmetic Products

To ensure transparency and safety, manufacturers must adhere to specific labeling regulations under the Drugs & Cosmetics Rules, 1945:

• The outer label must clearly state the ingredients used in manufacturing.

• A batch number starting with "B" and manufacturing batch with "M" must be indicated.

• The product name must be clearly displayed on both inner and outer labels.

• For small containers, the principal place and pin code are sufficient.

• The inner label should contain directions for use and necessary warnings.

• The Bureau of Indian Standards (BIS) may check and revise product quality standards periodically.

Documents Required for Cosmetic Manufacturing License

To obtain a CDSCO Manufacturing License for Cosmetics, the following documents are required:

• Application Form COS-5.

• Specific Power of Attorney for the authorized signatory.

• List of Directors, Partners, Trustees, along with ROC copies or registered Partnership/Trust Deed.

• Covering letter.

• Appointment letter of competent technical staff (optional but preferred).

• List of plant and machinery.

• Manufacturing process details and flow chart.

• Site Master File.

• Firm's constitutional details.

• List of Standard Operating Procedures (SOPs).

• Challan of fees paid.

• Copy of draft label.

• Site plan and layout of the building.

• Self-attested property ownership or lease documents.

• List of technical staff with qualifications and experience.

Procedure for Obtaining Cosmetic Manufacturing License

Step 1: Filing of Application

• The application must be filed in Form COS-5. Professional assistance can simplify the filing process and ensure that all necessary details are accurately included.

Step 2: Document Submission

• Submit all required documents along with the application form to the appropriate State Licensing Authority.

Step 3: Examination by Authority

• Once submitted, the licensing authority examines the application and documents. This may include on-site inspections to verify compliance.

Step 4: Issuance of License

• Upon satisfaction with the provided details and inspection, the Licensing Authority issues the Cosmetic Manufacturing License in Form COS-8.

Validity of Cosmetic Manufacturing License

The CDSCO Cosmetic Manufacturing License issued in Form COS-8 remains valid perpetually, subject to timely payment of license retention fees every five years. If the fee is not paid, or if the manufacturer fails to comply with regulations, the license may be suspended or cancelled by the State Licensing Authority.

CDSCO Cosmetic Import License

Cosmetic industry in India is expanding very fast, with a significant demand for cosmetic and personal care products. To ensure the safety, quality, and performance of these imported cosmetics, it is mandatory to obtain a CDSCO Cosmetic Import License. This license is issued by the Central Drug Standard Control Organisation (CDSCO), which operates under the Ministry of Health & Family Welfare. Governed by Rule 21 of the Drugs and Cosmetics Rules, 1945, the CDSCO Import License for Cosmetics ensures that only safe and standard products enter the Indian market. With this license, businesses can import and sell cosmetic products in India without any legal hassles.

A cosmetic is defined as any substance intended to be applied, sprayed, poured, or introduced into the human body for cleansing, beautifying, altering appearance, or enhancing attractiveness. This definition also includes any articles used as a component of cosmetic products. Understanding this definition is essential as it determines the scope of products that require a CDSCO Cosmetic License for Import.

Role of CDSCO in Cosmetic Import License

CDSCO plays a critical role in regulating the import of cosmetics into India. The responsibilities include:

• Implementing the amended Cosmetic Rules, 2020, concerning the import and registration of cosmetic products.

• Evaluating applications for No Objection Certificates (NOC) and providing clarifications related to cosmetic imports.

• Handling complaints from NGOs, public forums, or consumers regarding the standards of imported cosmetics.

• Responding to government correspondences or queries from the Bureau of Indian Standards (BIS).

• Reviewing applications for the CDSCO Cosmetic Import Registration and ensuring they meet the criteria laid down in the Drugs and Cosmetics Act, 1940.

• Addressing public inquiries, providing guidance, and handling hearing processes related to cosmetic import registration.

• Drafting replies to Right to Information (RTI) queries, court cases, parliamentary questions, and VIP references concerning cosmetic regulations.

Who Can Apply for CDSCO Cosmetic Import Registration?

According to the Drugs & Cosmetics Act, 1945, the following entities are eligible to apply for a CDSCO Cosmetic Import License:

Authorized Agent: A manufacturer can authorize an agent to apply on their behalf.

Subsidiary of the Manufacturer: If the foreign manufacturer has an Indian subsidiary, the subsidiary can apply for the registration.

Manufacturer: The manufacturer itself can directly apply for the import registration.

Other Importers: Any Indian importer intending to import cosmetic products from a foreign manufacturer can also apply.

Essential Documents for CDSCO Cosmetic Import License Registration

The following documents are crucial for a successful CDSCO Cosmetic License for Import registration:

Covering Letter: Clearly mention the purpose of the application, whether it is for a fresh registration, endorsement of products, pack size, manufacturing site, additional sourcing location, or re-registration.

Part-1 of Second Schedule: Provide details and undertakings by the manufacturer or authorized distributor.

List of Composition or Ingredients: Include cosmetic name, ingredients with percentage, and ensure compliance with the permissible limits for heavy metals like lead, arsenic, and mercury.

Labels of Proposed Products: Labels must include product name, manufacturer details, expiry date, batch number, manufacturing license number, importer details, and ingredient list.

Specification & Testing Methods: Submit specifications and protocols for product testing as per the Cosmetic Rules, 2020.

Pack Insert (If Any): Include any informational inserts that accompany the product.

Manufacturing Licenses: Certified copy of the manufacturing license issued by the regulatory authority from the country of origin.

Free Sale Certificate: Issued by the regulatory authority or Indian Embassy of the country of origin, confirming that the product is freely sold in that country.

Declaration of Non-Animal Testing: Confirm that the product has not been tested on animals.

Declaration for Heavy Metal & Hexachlorophene: Ensure the product is compliant with the safety standards.

Application COS-1 Form: Submit the correctly filled application form.

TR-6 Challan: Proof of fee payment.

Procedure for CDSCO Cosmetic Import License Registration in India

Step 1: Determination of Cosmetics Classification The manufacturer must first identify the classification of their cosmetic products according to the Gazette Notification of CDSCO to understand the regulatory framework and requirements.

Step 2: Appointment of an Indian Agent The foreign manufacturer should appoint an authorized Indian agent who will act as a liaison with CDSCO. The agent must have a Power of Attorney to assist in registration and importation.

Step 3: Filling and Submission of the Application Once an agent is appointed, the manufacturer or importer must fill out the registration application form. The application, along with the necessary documents and fee, should be submitted online through the CDSCO portal.

Step 4: Issuance of CDSCO Cosmetic Import Registration Certificate After submission, the Drug Controller General of India (DGCI) will review the application. If required, queries may be raised for additional information or clarification. Once satisfied, CDSCO will issue the Cosmetic Import License, allowing the importer to proceed with the import and sale of cosmetics in India.

Getting a CDSCO Cosmetic Import License is a mandatory step for importing cosmetic products into India. The process ensures that only quality, safe, and compliant products enter the Indian market, protecting consumer interests and promoting health and safety. Hvaing the knowledge of the role of CDSCO, eligibility criteria, required documents, and registration procedure, applicants can streamline their registration process. For expert guidance on obtaining a CDSCO Import License for Cosmetics, feel free to consult with our experienced professionals or you can book a consultation with our CDSCO experts through main info@ccoffice.in or Call/Whatsapp us at +91 9988424211.

CDSCO In Vitro Diagnostic Device (IVD) Manufacturing License

The manufacturing of In Vitro Diagnostic Devices (IVD) in India is regulated under the Drugs and Cosmetics Act, 1940, and the Rules of 1945. In 2017, the Government of India introduced new guidelines for the registration and licensing of medical devices and IVDs. This regulation ensures that the manufacturing processes meet high-quality standards and promote patient safety. If you are looking to obtain a CDSCO IVD Device Manufacturing License, this guide will explain the process, classification, required documentation, and application steps in detail.

In Vitro Diagnostic Devices (IVDs) include kits, reagents, instruments, and systems designed to diagnose diseases, determine health conditions, and support treatment and prevention strategies. These devices are utilized for collecting, preparing, and examining specimens obtained from the human body.

Classification of IVDs Under Medical Device Rules, 2017

The Medical Device Rules, 2017 categorize IVD devices based on risk and intended use:

1. Risk-Based Classification:

   • Class A (Low Risk)

   • Class B (Low-Moderate Risk)

   • Class C (Moderate-High Risk)

   • Class D (High Risk)

2. Classification Based on Intended Use:

   • Devices for diagnosing HIV

   • Devices for detecting HBV (Hepatitis B Virus)

   • Devices for identifying HCV (Hepatitis C Virus)

   • Blood Grouping Sera devices

Regulatory Authorities for IVD Manufacturing Licensing

The responsibility for licensing IVD manufacturing is shared between two authorities based on the risk classification:

1. State Licensing Authority (SLA)

   • SLA is responsible for issuing manufacturing licenses for Class A and Class B IVDs.

   • Applications should be submitted to the respective State Drugs Control Authority.

2. Central Licensing Authority (CLA)

   • CLA handles licenses for Class C and Class D IVDs.

Types of Licenses and Applicable Forms

The types of licenses for manufacturing IVD devices are categorized based on the device class and license type (manufacturing or loan license):

1. Manufacturing License for Class A & B:

   • Application Form: MD-3

   • Approval Form: MD-5

2. Loan License for Class A & B:

   • Application Form: MD-4

   • Approval Form: MD-6

3. Manufacturing License for Class C & D:

   • Application Form: MD-7

   • Approval Form: MD-9

4. Loan License for Class C & D:

   • Application Form: MD-8

   • Approval Form: MD-9

Documents Required for CDSCO IVD Device Manufacturing License

To apply for a CDSCO Manufacturing License for In Vitro Diagnostic Device, the following documents are mandatory:

• Covering Letter addressing the application details.

• Duly Filled Application Form as per the relevant device class.

• Fee Challan Receipt as proof of payment.

• Company Constitution Documents, including:

  • Partnership Deed (for partnership firms).

  • Memorandum & Articles of Association (for companies).

• Details of Directors/Partners (age, address, ID proof).

• Site Ownership Documents or valid Rental Agreement.

• Declaration of Manufacturing and Analytical Chemists.

• Educational Qualifications and Experience Certificates for chemists.

• Appointment Letters and ID Proof of appointed chemists.

• Registration Certificate from District Industries Centre.

• Consent from State Pollution Control Board.

• Performance Evaluation Reports (if applicable).

• Copy of Test License (if applicable).

• Undertaking confirming adherence to the Fifth Schedule requirements.

For Loan License Applications (MD-4), additional documents include:

• Consent Letter from Principal Manufacturer.

• Wholesale License of the Loan Licensee.

• Valid Manufacturing License and Product Permissions of the principal manufacturer.

Process to Obtain CDSCO IVD Device Manufacturing License

Obtaining a CDSCO In Vitro Diagnostic Device License involves the following steps:

Step 1: Filing the Application: Submit the application in the prescribed form along with the required documents and fees to the CDSCO or the respective SLA.

Step 2: Scrutiny of Application: The authority will review the application for completeness and compliance. Any discrepancies will be communicated to the applicant for correction.

Step 3: Site Audit by Notified Body: The manufacturing site will undergo an audit by an authorized body. Any non-compliance issues must be resolved, and the compliance report submitted.

Step 4: Examination of Audit Report: The audit report is thoroughly examined. If the report meets the regulatory standards, the application proceeds to the next stage.

Step 5: Product Scrutiny: Details of the IVD products are scrutinized to ensure they meet all safety and regulatory norms.

Step 6: Grant of License: Upon successful scrutiny and audit, the manufacturing license is granted, allowing the company to commence the manufacturing of IVD devices. 

CDSCO In Vitro Diagnostic Device (IVD) Import License

If you are planning to import In Vitro Diagnostic (IVD) devices into India, understanding the import license process governed by the Central Drugs Standard Control Organization (CDSCO) is essential. Under the New Medical Device Rules, 2017, obtaining a CDSCO Import License for In Vitro Diagnostic Devices is mandatory. This guide will walk you through the detailed process, eligibility, required documentation, and important points to consider when applying for a CDSCO IVD Device Import License.

Who Can Apply for a CDSCO IVD Device Import License?

Foreign manufacturers cannot directly apply for an IVD import license in India. Instead, they must appoint an Indian entity as an authorized agent. This authorized agent must possess either a license to manufacture for sale or distribution or a wholesale license for the sale and distribution of medical devices in India. The agent will submit the application to CDSCO on behalf of the foreign manufacturer. The appointment of the agent must be formalized through a 'Power of Attorney' document, granting them the authority to act on behalf of the overseas manufacturer.

Forms Required for CDSCO Import License for In Vitro Diagnostic Device

To apply for the CDSCO In Vitro Diagnostic Device Import License, the following forms are required:

• MD-14: This is the application form to obtain an import license for IVD devices.

• MD-15: This form is issued by the central licensing agency, CDSCO, granting permission to import the IVD diagnostic kit.

These forms cover all risk categories of IVD devices classified as Category A, B, C, and D.

Process to Apply for CDSCO In Vitro Diagnostic Device Import License

Evaluation of Product

Before submitting an application, it is important to evaluate whether the IVD device meets the basic norms as per the Medical Device Rules, 2017. This evaluation ensures that the product complies with the required standards and is fit for import into India.

Classification of Product

Once evaluated, classify the IVD device based on the risk category (A, B, C, or D). The classification is a crucial step in determining the regulatory pathway and documentation required for the license.

Documentation Preparation

Prepare all the necessary documentation in compliance with the Medical Device Rules, 2017. Ensure all documents are signed by the authorized signatory.

Appointment of Authorized Agent

Foreign manufacturers must appoint an authorized agent in India through a Power of Attorney. This agent should have a valid license to manufacture for sale or distribution or a wholesale license for sale and distribution.

Submission of Application Form

The authorized agent must generate and fill out the MD-14 form on the CDSCO’s online SUGAM portal. All necessary documents must be attached.

Approval and Submission

The authorized agent should review the draft application, ensure accuracy, and then submit it through the online portal.

Follow-Up with CDSCO

After submission, the agent must follow up with CDSCO to address any queries or additional information requests.

Grant of License

Once the CDSCO reviews and approves the application, they will issue the MD-15 form, granting the import license for the IVD device.

Important Documents Required for CDSCO IVD Device Import License

The following key documents are required for submitting an application:

• Covering Letter: Indicate whether the application is for registration or re-registration. Include a list of all attached documents, signed by an authorized signatory.

• Product Details: Full details of the products intended for import.

• Manufacturing Site Details: Information about the site where the IVD devices are manufactured.

• Regulatory Documents: Attach necessary documents as per Form MD-14.

• Power of Attorney: Document authorizing the Indian agent to act on behalf of the manufacturer.

• ISO 13485 Certificate: Ensures quality management standards for medical devices.

• TR-6 Challan: Proof of fee payment.

• GMP Certificate: Good Manufacturing Practices certificate.

• CE Design Certificate: Ensures that the product meets EU safety standards.

• Declaration of Conformity: A statement that the product meets regulatory requirements.

• Post-Market Surveillance (PMS) Report: Ongoing monitoring data of the product's performance.

• Business License/Plant Registration Certificate: Certifies the manufacturing facility.

• Audit Report: Details of internal and external audits.

• Agent Constitution Details: Proof of the legal existence of the Indian agent.

• Valid Wholesale/Manufacture License: Required for the authorized Indian agent.

• Quality Certificate: Assurance of product quality from the overseas manufacturer.

• Free Sale Certificate (FSC): Confirms that the product is freely sold and approved in the country of export.

• Device Master File and Site Master File: Detailed documents including manufacturing procedures, characterization, composition, and quality control processes.

• Batch Release Certificate and Detailed Test Report: For product quality assurance.

Validity of the CDSCO Import License for In Vitro Diagnostic Device

Once granted, the import license (Form MD-15) remains valid indefinitely. However, the license holder must pay the retention fees as per the second schedule of the Medical Device Rules, 2017, before the expiry of every five-year term. The license remains valid unless it is suspended or canceled by CDSCO due to non-compliance.

Important Points to Remember Before Applying for an IVD Import License

Free Sale Certificate: Ensure availability of the FSC from GHTF countries.

Multiple Manufacturing Sites: Verify the number of manufacturing sites involved.

Power of Attorney: Ensure it is formatted according to Medical Device Rules, 2017

Document Format: Device Master File and Site Master File must adhere to the guidelines.

Apostillation and Notary: All legal documents must be apostilled and notarized as per the rules.

Authorized Agent Criteria: The agent must have a valid manufacturing or wholesale license for sale and distribution of IVD devices in India.

By following these steps and ensuring all documentation and regulatory requirements are met, applicants can smoothly obtain a CDSCO In Vitro Diagnostic Device Import License. This will ensure compliance with Indian regulations and facilitate the lawful import and sale of IVD devices in India.

CDSCO Drug License in India

In India, businesses operating in the healthcare sector, including those dealing with medicines, drugs, or cosmetics, are mandated to obtain a Drug License from the relevant authority. As per the Drugs and Cosmetics Act, the license is issued by either the State or Central Drug Standard Control Organization (CDSCO). The CDSCO Drug License ensures that the manufacture, sale, and distribution of drugs are conducted under regulated conditions to ensure consumer safety.

Need for CDSCO Drug License

Drugs form the core of medical treatments, created under medically defined ratios. These drugs, when used in medicines, are aimed at curing diseases and improving the well-being of individuals. The preparation and application of such drugs are regulated to ensure they are administered in the correct amounts, avoiding harmful overdoses. Any violation of these defined limits can have severe health consequences. To protect consumers, the government enforces strict laws and regulations for the manufacturing, distribution, and sale of drugs and medicines. Compliance with these regulations is mandatory for both manufacturers and distributors.

Types of Drug Licenses Issued in India

There are various types of Drug Licenses issued depending on the type of business. Each license serves a specific function, ensuring that drugs and medicines meet the legal standards and guidelines.

1. Manufacturing Drug License: This license is essential for manufacturers producing allopathic, ayurvedic, cosmetic, or any other drugs specified under the Drugs and Cosmetics Act, 1940. It is issued by the state government where the manufacturing unit is situated.

2. Loan Drug License: This type of license is for manufacturers who do not own a manufacturing unit but want to produce drugs under their brand name using a facility already licensed.

3. Import Drug License: Businesses engaged in importing drugs or raw materials for drug manufacturing must obtain this license to legally bring products into India.

4. Multi-Drug License: Entities operating in multiple states with multiple units require a Multi-Drug License to comply with regulations across regions.

5. Sale Drug License: This license is necessary for entities engaged in wholesale or retail distribution of drugs across India.

6. Wholesale Drug License: Wholesalers dealing in pharmaceuticals must obtain this license from the CDSCO. Applicants must meet minimum criteria, including holding a degree or diploma in pharmacy and possessing at least one year of experience in drug dealing.

7. Retail Drug License: Retailers, including standalone pharmacists and pharmacies, must apply for this license through the State Pharmacy Council.

Requirements for Obtaining Drug License under CDSCO in India

Before applying for a Drug License under CDSCO, certain essential requirements must be met to ensure smooth processing and approval.

Premise Area: A minimum area of 10 square meters is required for setting up a medical shop or retail pharmacy. If both retail and wholesale businesses are conducted, a minimum of 15 square meters is necessary.

Storage Facilities: Proper storage facilities, including cold storage and refrigeration, must be available to store medicines and vaccines appropriately.

Technical and Expert Staff: Retail pharmacies should employ qualified and technically trained staff with in-depth knowledge of pharmaceuticals.

Regional-Specific License: Drug licenses are region-specific and must be obtained for each location where drugs are stocked or sold.

Compliance with Terms: License holders must comply with all terms and conditions. Failure to do so can result in license suspension or cancellation. Authorities must be notified of any business modifications.

Documents Required for Obtaining Drug License

The following documents are essential while applying for a Drug License in India:

• Duly signed application form.

• Copy of challan as proof of the deposited fee.

• Identity proof like PAN card, Voter ID, Driving License, or Passport for proprietors.

• For partnership firms, ID proof of each partner along with the partnership deed.

• For companies, a copy of the Memorandum of Association (MOA), Articles of Association (AOA), and Certificate of Incorporation (COI).

• Certified true copy (CTC) of the board resolution authorizing the company to obtain the license.

• Appointment letter of the authorized person applying for the license.

• Proof of storage space, such as cold storage or refrigeration facilities.

Additional Documents for Registered Pharmacists:

• Diploma or degree in pharmacy.

• Registration certificate from the Pharmacy Council.

• Appointment letter from the employer.

• Affidavit of the pharmacist.

• Educational qualification certificates, including mark sheets and degree certificates.

• Proof of at least one year of experience in drug sales or marketing.

• Layout plan of the premise.

• Availability of basic utilities like electricity.

How to Apply for Drug License under CDSCO in India?

The process to obtain a Drug License under CDSCO involves multiple steps:

Online Registration: Applicants must apply online based on the type of business and the license required.

Unique Registration Number: After completing the online form, the system will generate a unique registration number for future reference.

Submission of Documents: Within 15 days of online registration, applicants must submit hard copies of all necessary documents to the Drug Licensing Authority of the concerned district.

Verification and Inspection: Authorities may conduct inspections to verify the premises and documentation before approving the license.

Grant of License: Once all criteria are met and the application is approved, the license will be granted.