CDSCO Manufacturing License for Medical Devices in India

CDSCO Manufacturing License for Medical Devices in India. The Central Drugs Standard Control Organization (CDSCO) is the main regulatory body in India, supervising the registration and regulation of medical devices to ensure their safety and efficacy. If you are looking to manufacture medical devices in India, obtaining a CDSCO Manufacturing License for Medical Devices is a mandatory requirement. This article is designed to provide a complete overview of the process, phases, documentation, and requirements involved in securing a CDSCO license in India.
Introduction to CDSCO Medical Device Registration
The CDSCO Medical Device Registration process is part of the regulatory framework designed to ensure that all medical devices meet the necessary quality and safety standards. The licensing is governed by the Central Licensing Approval Authority (CLAA) scheme, under which the State Licensing Authority grants the license, subject to approval from the CLAA. The licensee is required to comply with the standards laid down under the Medical Devices Rules.
Manufacturers importing raw materials, semi-finished products, or components into India must ensure that final assembly and packaging are carried out within the country under a CDSCO Manufacturing License. However, if a company imports a fully finished product, it will require a CDSCO import license to sell the product in the Indian market.
Phases of CDSCO Manufacturing License Process
Phase I – Applicant Registration for CDSCO Manufacturing License
The first step in the process is registering on the CDSCO portal. This involves generating login credentials by submitting certain key documents. The essential documents for registration include proof of address, such as a certificate of registration, certificate of incorporation, import-export certificate, or utility bills like MTNL/BSNL bills. Additionally, ID proof of an authorized person handling the registration process is required. After uploading these documents online, a preliminary approval mail is received from CDSCO. Subsequently, an instruction to submit hard copies of the documents follows.
Phase II – CDSCO Manufacturing Test License Application
In the second phase, applicants must apply for a CDSCO Manufacturing Test License. This license is essential for producing a limited quantity of medical devices for the purpose of testing, evaluation, demonstration, and training of personnel. The procedure involves applying via the CDSCO online portal using Form MD-12. It is important to ensure accurate submission of details, upload necessary documents, and pay the prescribed fees. The status of the application is regularly updated, allowing applicants to track their application’s progress.
Phase III – CDSCO Manufacturing License Application
The final phase involves applying for a CDSCO Manufacturing License for commercial production. Manufacturers must submit their application online through the CDSCO portal. For Class A and Class B devices, Form MD-3 needs to be filled, while for Class C and Class D devices, Form MD-7 is required. Along with the application, relevant documents must be uploaded, and fee payments completed as per CDSCO regulations. Upon submission, applicants will receive an email regarding the approval or rejection of their application.
Classification of Medical Devices under CDSCO
The CDSCO classifies medical devices based on the risk they pose to users and patients. This classification ensures appropriate regulatory scrutiny for each device type. The classifications are as follows:
1. Class A (Low Risk): Devices like stethoscopes, bandages, and simple instruments that pose minimal risk.
2. Class B (Low to Moderate Risk): Devices such as blood pressure monitors, syringes, and needles that may cause harm if malfunctioning but are not life-threatening.
3. Class C (Moderate to High Risk): Devices like orthopedic implants, artificial heart valves, and catheters that have the potential to cause serious harm if they malfunction.
4. Class D (High Risk): Critical devices such as pacemakers, ventilators, and heart-lung machines that could cause severe harm or death if they fail.
CDSCO Forms for Medical Device Registration
The following are the different form for Medical Device Registration under CDSCO
CDSCO Forms for Registration of Existing Medical Devices
For the registration of existing medical devices, CDSCO has outlined specific forms based on the category and purpose:
1. Import License Application (Form MD-14 and MD-15): Importers looking to register medical devices under Categories A, B, C, and D must submit Form MD-14 for application and will be granted permission through Form MD-15. This process ensures that importers meet the necessary compliance standards for bringing medical devices into India.
2. Manufacturing License for Categories A & B (Form MD-3 and MD-5): Manufacturers intending to produce medical devices categorized as A or B are required to apply through Form MD-3. Upon successful evaluation, permission is granted via Form MD-5, enabling them to legally manufacture these devices in India.
3. Loan License for Manufacturing (Form MD-4 and MD-6): Manufacturers who seek a loan license—where production occurs in another licensed manufacturing facility—must submit Form MD-4. The corresponding permission is issued through Form MD-6, ensuring legal compliance for such manufacturing arrangements.
4. Manufacturing License for Categories C & D (Form MD-7 and MD-9): For medical devices falling under the higher-risk Categories C and D, manufacturers must apply via Form MD-7. Upon fulfilling all regulatory requirements, permission is granted through Form MD-9.
5. Loan License for Categories C & D (Form MD-8 and MD-10): Manufacturers desiring a loan license for Categories C and D must use Form MD-8 for application, and upon approval, Form MD-10 is issued.
CDSCO Forms for Registration of New Medical Devices
For new medical devices, separate application forms are designated depending on the purpose of registration:
1. Clinical Investigation Permission (Form MD-22 and MD-23): Importers seeking permission to conduct clinical investigations on medical devices under Categories A, B, C, and D must submit Form MD-22. Once approved, Form MD-23 is issued, allowing the clinical investigation to proceed.
2. Import License Application (Form MD-26 and MD-27): To import new medical devices into India, importers must submit Form MD-26. Successful applications result in permission granted through Form MD-27.
3. Test License for Clinical Trials (Form MD-16 and MD-17): For obtaining a test license—necessary for conducting clinical trials or testing medical devices in India—applicants must use Form MD-16, and upon approval, Form MD-17 is issued.
Documents Required for CDSCO Medical Device Manufacturing License
Here is a list of documents required for obtaining a CDSCO Medical Device Manufacturing License in India:
1. Company Registration Documents: Certificate of Incorporation, MOA, AOA, GST Certificate, PAN Card, and registered office proof.
2. Covering Letter: A formal letter stating the purpose of the application.
3. Application Form: Form MD-3 for Class A & B or Form MD-7 for Class C & D devices.
4. Device Master File (DMF): Detailed information about the device, including specifications, intended use, manufacturing process, risk analysis, and labeling.
5. Plant Master File (PMF): Details of the manufacturing facility, including infrastructure, machinery, and quality control measures.
6. ISO 13485 Certification: Certificate for the quality management system of medical devices.
7. Good Manufacturing Practice (GMP) Certificate:Certification proving adherence to GMP standards.
8. Free Sale Certificate (FSC): If the device is already sold internationally.
9. Undertakings and Declarations: Statements confirming compliance with Medical Device Rules, 2017.
10. List of Technical Personnel: Details and qualifications of technical staff involved in manufacturing and quality control.
11. Site Master File: Information about the manufacturing site, if applicable.
12. Authorized Signatory Authorization: Letter authorizing an individual to submit and sign the application.
13. Testing Protocols and Reports: Product testing details to ensure safety and performance.
14. Environmental Clearance Certificate: If applicable for certain devices or manufacturing processes.
15. Trademark Registration Certificate: If the product has been trademarked.
16. Facility Inspection Reports: Previous inspection reports, if any.
17. Fee Receipt: Proof of payment for the application.
18. Previous Regulatory Approvals: Any earlier certificates or approvals from regulatory authorities.
License Renewal Documents
(a) Copy of the existing license.
(b) Updated DMF and PMF confirming no major changes.
(c) Fee receipt for the renewal application.
(d) Declaration of any changes made since the last license issuance
Procedure to Obtain CDSCO Manufacturing License for Medical Devices
To ensure a smooth process of securing a CDSCO Manufacturing License, manufacturers must follow these detailed steps:
The first step is Device Classification, where the manufacturer must determine the classification of the medical device according to CDSCO guidelines. Devices are categorized into Classes A, B, C, or D based on risk levels, with Class A being low-risk and Class D being high-risk. This classification is crucial as it dictates the regulatory pathway and documentation requirements.
Following classification, the manufacturer must focus on Technical Documentation, which involves preparing detailed records about the medical device. This includes a complete device description, technical specifications, intended use, and performance data. Additionally, safety assessments, risk analyses, and clinical evaluations (if applicable) should be documented to demonstrate that the device meets safety and performance standards.
Once the technical documents are ready, the Application Submission phase begins. The manufacturer must submit the application to CDSCO, accompanied by the technical documentation, a cover letter outlining the purpose of the application, and the applicable processing fees. Ensuring that all documents are accurate and complete is crucial for smooth processing.
In the CDSCO Review stage, the regulatory authority thoroughly reviews the submitted application and documentation. If any gaps or inconsistencies are identified, the CDSCO may request additional information or clarifications. Prompt and accurate responses to such queries help avoid unnecessary delays.
Following the documentation review, CDSCO may conduct a Facility Inspection to verify whether the manufacturing facility complies with the required Good Manufacturing Practices (GMP). The inspection ensures that the facility follows appropriate processes, maintains quality control, and adheres to safety protocols essential for manufacturing medical devices.
If the inspection is successful and all documentation meets the required standards, the License Issuance process takes place. The CDSCO grants the manufacturing license, officially permitting the manufacturer to produce and market the medical devices in India.
License Renewal is an important compliance aspect. The issued manufacturing license is typically valid for five years. Manufacturers must initiate the renewal process well before the license's expiration to avoid operational disruptions. Timely submission of renewal applications, along with the updated compliance documentation, ensures the continuity of business operations.
Renewal of CDSCO Medical Device Manufacturing License
The CDSCO mandates that the medical device manufacturing license must be renewed at least nine months before its expiry date. This proactive timeline ensures continuity in the manufacturing process without legal interruptions.
For renewal, while no additional documents are required, the license holder must submit the following to validate that no alterations have been made to the existing manufacturing process:
(a) Plant Master File (PMP): A complete document detailing the manufacturing plant, infrastructure, and processes.
(b) Device Master File (DMF): A detailed file containing specifications and standards for the manufacturing of the medical device.
This submission confirms the consistency and quality standards of the manufacturing process, ensuring that the existing conditions remain compliant with regulatory expectations.
Conclusion
Getting a CDSCO Manufacturing License for Medical Devices is an essential step for ensuring the safety and efficacy of medical devices in India. By adhering to the detailed process and complying with regulatory requirements, manufacturers can ensure a smoother path to market entry. Expert guidance can significantly ease the process, ensuring that all regulatory standards are met efficiently. For more details and expert assistance, feel free to contact our team through email info@ccoffice.in or Whatsapp/Call Us at +91 9988424211.
FAQs
Q1. What is a CDSCO Medical Device Manufacturing License?
Ans. A CDSCO Medical Device Manufacturing License is an official approval granted by the Central Drugs Standard Control Organization (CDSCO), permitting a company to manufacture medical devices in India as per the Medical Device Rules, 2017.
Q2. Which medical devices require a manufacturing license from CDSCO?
Ans. All medical devices categorized under Class A, B, C, and D require a CDSCO manufacturing license. Class A and B devices are considered low to moderate risk, while Class C and D devices are high-risk.
Q3. What are the key documents required for obtaining a CDSCO manufacturing license?
Ans. The essential documents include:
(a) Company Registration Certificate (Incorporation, MOA, AOA)
(b) Device Master File (DMF) and Plant Master File (PMF)
(c) ISO 13485 Certificate and GMP Certificate
(d) Filled application form (MD-3 or MD-7)
(e) Covering letter, fee receipt, and list of technical staff.
Q4. What is the validity period of a CDSCO manufacturing license?
Ans. The CDSCO manufacturing license is valid for five years from the date of issuance. Manufacturers must apply for renewal at least nine months before the expiry date.
Q5.How can I renew my CDSCO Medical Device Manufacturing License?
Ans. To renew the license, submit the following to CDSCO:
(a) Copy of the existing license.
(b) Updated Device Master File (DMF) and Plant Master File (PMF).
(c) Fee payment receipt for renewal.
(d) Declaration of no significant changes in the manufacturing process.
Q6. Is facility inspection mandatory for obtaining a manufacturing license?
Ans. Yes, CDSCO conducts an inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP) and regulatory standards before granting the manufacturing license.
Q7. What should be done if there is a change in the manufacturing setup or company structure?
Ans. If there are changes in the company's structure, office address, or manufacturing process, the manufacturer must notify CDSCO immediately. The existing license remains valid for three months, during which the manufacturer must apply for an updated license.

The Central Drugs Standard Control Organization (CDSCO) is the main regulatory body in India, supervising the registration and regulation of medical devices to ensure their safety and efficacy. If you are looking to manufacture medical devices in India, obtaining a CDSCO Manufacturing License for Medical Devices is a mandatory requirement. This article is designed to provide a complete overview of the process, phases, documentation, and requirements involved in securing a CDSCO license in India.

Introduction to CDSCO Medical Device Registration

The CDSCO Medical Device Registration process is part of the regulatory framework designed to ensure that all medical devices meet the necessary quality and safety standards. The licensing is governed by the Central Licensing Approval Authority (CLAA) scheme, under which the State Licensing Authority grants the license, subject to approval from the CLAA. The licensee is required to comply with the standards laid down under the Medical Devices Rules.

Manufacturers importing raw materials, semi-finished products, or components into India must ensure that final assembly and packaging are carried out within the country under a CDSCO Manufacturing License. However, if a company imports a fully finished product, it will require a CDSCO import license to sell the product in the Indian market.

Phases of CDSCO Manufacturing License Process

Phase I – Applicant Registration for CDSCO Manufacturing License

The first step in the process is registering on the CDSCO portal. This involves generating login credentials by submitting certain key documents. The essential documents for registration include proof of address, such as a certificate of registration, certificate of incorporation, import-export certificate, or utility bills like MTNL/BSNL bills. Additionally, ID proof of an authorized person handling the registration process is required. After uploading these documents online, a preliminary approval mail is received from CDSCO. Subsequently, an instruction to submit hard copies of the documents follows.

Phase II – CDSCO Manufacturing Test License Application

In the second phase, applicants must apply for a CDSCO Manufacturing Test License. This license is essential for producing a limited quantity of medical devices for the purpose of testing, evaluation, demonstration, and training of personnel. The procedure involves applying via the CDSCO online portal using Form MD-12. It is important to ensure accurate submission of details, upload necessary documents, and pay the prescribed fees. The status of the application is regularly updated, allowing applicants to track their application’s progress.

Phase III – CDSCO Manufacturing License Application

The final phase involves applying for a CDSCO Manufacturing License for commercial production. Manufacturers must submit their application online through the CDSCO portal. For Class A and Class B devices, Form MD-3 needs to be filled, while for Class C and Class D devices, Form MD-7 is required. Along with the application, relevant documents must be uploaded, and fee payments completed as per CDSCO regulations. Upon submission, applicants will receive an email regarding the approval or rejection of their application.

Classification of Medical Devices under CDSCO

The CDSCO classifies medical devices based on the risk they pose to users and patients. This classification ensures appropriate regulatory scrutiny for each device type. The classifications are as follows:

1. Class A (Low Risk): Devices like stethoscopes, bandages, and simple instruments that pose minimal risk.

2. Class B (Low to Moderate Risk): Devices such as blood pressure monitors, syringes, and needles that may cause harm if malfunctioning but are not life-threatening.

3. Class C (Moderate to High Risk): Devices like orthopedic implants, artificial heart valves, and catheters that have the potential to cause serious harm if they malfunction.

4. Class D (High Risk): Critical devices such as pacemakers, ventilators, and heart-lung machines that could cause severe harm or death if they fail.

CDSCO Forms for Medical Device Registration

The following are the different form for Medical Device Registration under CDSCO

CDSCO Forms for Registration of Existing Medical Devices

For the registration of existing medical devices, CDSCO has outlined specific forms based on the category and purpose:

1. Import License Application (Form MD-14 and MD-15): Importers looking to register medical devices under Categories A, B, C, and D must submit Form MD-14 for application and will be granted permission through Form MD-15. This process ensures that importers meet the necessary compliance standards for bringing medical devices into India.

2. Manufacturing License for Categories A & B (Form MD-3 and MD-5): Manufacturers intending to produce medical devices categorized as A or B are required to apply through Form MD-3. Upon successful evaluation, permission is granted via Form MD-5, enabling them to legally manufacture these devices in India.

3. Loan License for Manufacturing (Form MD-4 and MD-6): Manufacturers who seek a loan license—where production occurs in another licensed manufacturing facility—must submit Form MD-4. The corresponding permission is issued through Form MD-6, ensuring legal compliance for such manufacturing arrangements.

4. Manufacturing License for Categories C & D (Form MD-7 and MD-9): For medical devices falling under the higher-risk Categories C and D, manufacturers must apply via Form MD-7. Upon fulfilling all regulatory requirements, permission is granted through Form MD-9.

5. Loan License for Categories C & D (Form MD-8 and MD-10): Manufacturers desiring a loan license for Categories C and D must use Form MD-8 for application, and upon approval, Form MD-10 is issued.

CDSCO Forms for Registration of New Medical Devices

For new medical devices, separate application forms are designated depending on the purpose of registration:

1. Clinical Investigation Permission (Form MD-22 and MD-23): Importers seeking permission to conduct clinical investigations on medical devices under Categories A, B, C, and D must submit Form MD-22. Once approved, Form MD-23 is issued, allowing the clinical investigation to proceed.

2. Import License Application (Form MD-26 and MD-27): To import new medical devices into India, importers must submit Form MD-26. Successful applications result in permission granted through Form MD-27.

3. Test License for Clinical Trials (Form MD-16 and MD-17): For obtaining a test license—necessary for conducting clinical trials or testing medical devices in India—applicants must use Form MD-16, and upon approval, Form MD-17 is issued.

Documents Required for CDSCO Medical Device Manufacturing License

Here is a list of documents required for obtaining a CDSCO Medical Device Manufacturing License in India:

1. Company Registration Documents: Certificate of Incorporation, MOA, AOA, GST Certificate, PAN Card, and registered office proof.

2. Covering Letter: A formal letter stating the purpose of the application.

3. Application Form: Form MD-3 for Class A & B or Form MD-7 for Class C & D devices.

4. Device Master File (DMF): Detailed information about the device, including specifications, intended use, manufacturing process, risk analysis, and labeling.

5. Plant Master File (PMF): Details of the manufacturing facility, including infrastructure, machinery, and quality control measures.

6. ISO 13485 Certification: Certificate for the quality management system of medical devices.

7. Good Manufacturing Practice (GMP) Certificate:Certification proving adherence to GMP standards.

8. Free Sale Certificate (FSC): If the device is already sold internationally.

9. Undertakings and Declarations: Statements confirming compliance with Medical Device Rules, 2017.

10. List of Technical Personnel: Details and qualifications of technical staff involved in manufacturing and quality control.

11. Site Master File: Information about the manufacturing site, if applicable.

12. Authorized Signatory Authorization: Letter authorizing an individual to submit and sign the application.

13. Testing Protocols and Reports: Product testing details to ensure safety and performance.

14. Environmental Clearance Certificate: If applicable for certain devices or manufacturing processes.

15. Trademark Registration Certificate: If the product has been trademarked.

16. Facility Inspection Reports: Previous inspection reports, if any.

17. Fee Receipt: Proof of payment for the application.

18. Previous Regulatory Approvals: Any earlier certificates or approvals from regulatory authorities.

License Renewal Documents

(a) Copy of the existing license.

(b) Updated DMF and PMF confirming no major changes.

(d) Declaration of any changes made since the last license issuance

Procedure to Obtain CDSCO Manufacturing License for Medical Devices

To ensure a smooth process of securing a CDSCO Manufacturing License, manufacturers must follow these detailed steps:

The first step is Device Classification, where the manufacturer must determine the classification of the medical device according to CDSCO guidelines. Devices are categorized into Classes A, B, C, or D based on risk levels, with Class A being low-risk and Class D being high-risk. This classification is crucial as it dictates the regulatory pathway and documentation requirements.

Following classification, the manufacturer must focus on Technical Documentation, which involves preparing detailed records about the medical device. This includes a complete device description, technical specifications, intended use, and performance data. Additionally, safety assessments, risk analyses, and clinical evaluations (if applicable) should be documented to demonstrate that the device meets safety and performance standards.

Once the technical documents are ready, the Application Submission phase begins. The manufacturer must submit the application to CDSCO, accompanied by the technical documentation, a cover letter outlining the purpose of the application, and the applicable processing fees. Ensuring that all documents are accurate and complete is crucial for smooth processing.

In the CDSCO Review stage, the regulatory authority thoroughly reviews the submitted application and documentation. If any gaps or inconsistencies are identified, the CDSCO may request additional information or clarifications. Prompt and accurate responses to such queries help avoid unnecessary delays.

Following the documentation review, CDSCO may conduct a Facility Inspection to verify whether the manufacturing facility complies with the required Good Manufacturing Practices (GMP). The inspection ensures that the facility follows appropriate processes, maintains quality control, and adheres to safety protocols essential for manufacturing medical devices.

If the inspection is successful and all documentation meets the required standards, the License Issuance process takes place. The CDSCO grants the manufacturing license, officially permitting the manufacturer to produce and market the medical devices in India.

License Renewal is an important compliance aspect. The issued manufacturing license is typically valid for five years. Manufacturers must initiate the renewal process well before the license's expiration to avoid operational disruptions. Timely submission of renewal applications, along with the updated compliance documentation, ensures the continuity of business operations.

Renewal of CDSCO Medical Device Manufacturing License

The CDSCO mandates that the medical device manufacturing license must be renewed at least nine months before its expiry date. This proactive timeline ensures continuity in the manufacturing process without legal interruptions.

For renewal, while no additional documents are required, the license holder must submit the following to validate that no alterations have been made to the existing manufacturing process:

(a) Plant Master File (PMP): A complete document detailing the manufacturing plant, infrastructure, and processes.

(b) Device Master File (DMF): A detailed file containing specifications and standards for the manufacturing of the medical device.

This submission confirms the consistency and quality standards of the manufacturing process, ensuring that the existing conditions remain compliant with regulatory expectations.

Conclusion

Getting a CDSCO Manufacturing License for Medical Devices is an essential step for ensuring the safety and efficacy of medical devices in India. By adhering to the detailed process and complying with regulatory requirements, manufacturers can ensure a smoother path to market entry. Expert guidance can significantly ease the process, ensuring that all regulatory standards are met efficiently. For more details and expert assistance, feel free to contact our team through email info@ccoffice.in or Whatsapp/Call Us at +91 9988424211.

FAQs

Q1. What is a CDSCO Medical Device Manufacturing License?

Ans. A CDSCO Medical Device Manufacturing License is an official approval granted by the Central Drugs Standard Control Organization (CDSCO), permitting a company to manufacture medical devices in India as per the Medical Device Rules, 2017.

Q2. Which medical devices require a manufacturing license from CDSCO?

Ans. All medical devices categorized under Class A, B, C, and D require a CDSCO manufacturing license. Class A and B devices are considered low to moderate risk, while Class C and D devices are high-risk.

Q3. What are the key documents required for obtaining a CDSCO manufacturing license?

Ans. The essential documents include:

(a) Company Registration Certificate (Incorporation, MOA, AOA)

(b) Device Master File (DMF) and Plant Master File (PMF)

(d) Filled application form (MD-3 or MD-7)

(e) Covering letter, fee receipt, and list of technical staff.

Q4. What is the validity period of a CDSCO manufacturing license?

Ans. The CDSCO manufacturing license is valid for five years from the date of issuance. Manufacturers must apply for renewal at least nine months before the expiry date.

Q5.How can I renew my CDSCO Medical Device Manufacturing License?

Ans. To renew the license, submit the following to CDSCO:

(a) Copy of the existing license.

(b) Updated Device Master File (DMF) and Plant Master File (PMF).

(d) Declaration of no significant changes in the manufacturing process.

Q6. Is facility inspection mandatory for obtaining a manufacturing license?

Ans. Yes, CDSCO conducts an inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP) and regulatory standards before granting the manufacturing license.

Q7. What should be done if there is a change in the manufacturing setup or company structure?

Ans. If there are changes in the company's structure, office address, or manufacturing process, the manufacturer must notify CDSCO immediately. The existing license remains valid for three months, during which the manufacturer must apply for an updated license.