Central Drugs Standard Control Organization (CDSCO) regulates and monitors all medical devices in India. The CDSCO MD9 license permits the manufacture of class C and D medical devices in India. Class C and D medical devices are strictly regulated owing to their risk and impact. In this blog, we have prepared a detailed guide to help you easily get the CDSCO MD9 manufacturing license in 2026. This blog post covers the complete procedure as well as necessary documents for CDSCO MD 9 license application process.
CDSCO medical device classification system
To apply for CDSCO MD9 manufacturing license, you need to have a clear understanding of the CDSCO medical device classification system. Medical devices are grouped into four classes, A, B, C, and D, based on risk level and intended use. The classification system is sorted from the lowest to the highest risk. The CDSCO medical device classification helps determine the regulatory pathway and license required to launch your device. The manufacturer can fill in the registration and licensing paper work depending on the medical device class. In this blog, we have focused on class C and D devices.
- Class C: Moderate to high-risk medical devices are grouped as class C. Examples: cardiac stents, implantable devices, X-Ray machines, infusion pumps, MRI machines, and ventilators
- Class D: High-risk medical devices are grouped as class D. Examples: drug-eluting stents, implanted pacemakers, artificial joints, and heart valves
CDSCO manufacturing license for Class C and D medical devices
- Form MD 7: The application for CDSCO MD9 manufacturing license for class C and D medical device is filed under MD 7.
- CDSCO MD9 manufacturing license: The license to manufacture class C and D medical devices in India will be granted on MD 9.
Documents required to get CDSCO MD9 manufacturing license
An overview of the supporting documents required for CDSCO MD9 manufacturing license application for class C and D medical devices.
- Cover letter
- Application form
- Sale Deed/Rent Deed proving legal ownership of the manufacturing facility.
- Organization identity proof, such as UDYAM Aadhar, PAN card, etc.
- Building layout presenting the dimensions of each room and the location of all equipment in the manufacturing facility. This presents a detailed drawing of the medical device manufacturing facility.
- Plant master file
- Device master file
- Audit reports
- ISO 13485 Certificate validating the manufacturing facility meets international criteria for quality management systems.
- Document supporting compliance with the environmental regulatory requirements.
- Medical device test license. This will be required in case you need to test your medical devices before launching them in India.
- Certificate of Analysis of 3 Consecutive Batches. This document will certify that the first 3 batches of the manufactured devices meet the required quality benchmarks.
- Documents proving the manufacturing team comprises competent, qualified, and experienced staff who will manufacture and test the medical devices.
We have provided an overview of the supporting documents required for applying for CDSCO MD 9 license. For the detailed list of documents, feel free to reach out to us. Additionally, we will help prepare and compile the necessary supporting documents per CDSCO regulatory guidelines.
8-step guide to easily get CDSCO MD9 manufacturing license
We have prepared a detailed step-by-step guide to help you easily obtain CDSCO MD9 license for class C and D medical devices.
- Step 1: Identify the CDSCO medical device class: The first step is to correctly identity the CDSCO class for your medical device. Correct classification determines the applicable regulatory pathway. If your medical device belongs to CDSCO class C or D, then CDSCO MD9 manufacturing license will be required.
- Step 2: Login to SUGAM portal: Login or signup on the official online CDSCO medical device license application system, SUGAM.
- Step 3: Document preparation: Prepare all necessary supporting documents, including technical details, safety data, and quality certifications, relevant to the device. We have already summarised the list of documents require for CDSCO MD9 license application.
- Step 4: Fill in the application form correctly: Fill in the CDSCO MD 7 application form with all required information. Ensure accuracy and completeness.
- Step 5: Online application submission: Submit the completed application online along with the necessary fees and documents on the CDSCO online portal.
- Step 6: Application review: CDSCO officials will verify the submitted documents and review the application.
- Step 7: Facility inspection and audit: The CDSCO officials will inspect the manufacturing facility for regulatory compliance. Additionally, they may audit the facility.
- Step 8: Approval and licensing: Once all the criteria are fulfilled and officials are satisfied, CDSCO will grant the MD 9 license. The CDSCO MD9 manufacturing license will permit you to manufacture class C and D medical devices in India.
Licensing authority for CDSCO MD 9 license
Central Licensing Authority (CLA) is responsible for granting CDSCO MD 9 license for manufacturing class C and D medical devices in India.
Validity of the CDSCO MD 9 license
The CDSCO MD 9 license remains valid indefinitely unless cancelled or suspended. However, a license retention fee has to be paid every 5 years to maintain the validity.
How can Pharmadocx Consultants help you easily get CDSCO MD9 manufacturing license?
We have extensive expertise in CDSCO medical device licensing and registration. Our team will help you easily secure the CDSCO MD 9 license to manufacture class C and D medical devices in India.
- Correct identification of CDSCO medical device class: We will help you correctly classify your medical device per CDSCO medical device classification system.
- License application support: We will oversee the CDSCO MD9 license application process. Our team has proven expertise in license application.
- Document preparation support: Different classes of medical devices have different documentation requirements. We will help you prepare the necessary documents for securing the CDSCO license for manufacturing class C and D medical devices in India.
- Mock audit support: Pharmadocx Consultants team conducts mock audits to help their clients identify any noncompliance or shortcomings. Our mock audit service will prepare you for the inspection and audit carried out by the regulatory officials. Additionally, we provide audit document preparation support. Moreover, we will provide tips to overcome these shortcomings.
- CDSCO query response support: We will act as a liaison between you and CDSCO regulatory authorities. Our team will provide accurate and timely response to all CDSCO queries.
- Post license grant support: Our service does not end with assistance for license application. We provide post licensing and license renewal support. Our team will help you stay compliant with the latest CDSCO regulations for medical devices.
Call/Whatsapp us at 9996859227 or drop an email at [email protected] to easily get CDSCO MD9 manufacturing license for class C and D medical devices.
FAQs
What CDSCO class do high risk medical devices belong to?
High-risk medical devices are grouped as CDSCO class D.
What is CDSCO MD 9 license?
CDSCO MD 9 license grants the permission to manufacture class C and D medical devices in India.
Who grants the CDSCO MD9 manufacturing license?
Central Licensing Authority (CLA) grants the CDSCO MD9 manufacturing license
What is CDSCO medical device classification system?
Based on risk level and intended use, medical devices are grouped into four classes, A, B, C, and D. The CDSCO medical device classification system is sorted from the lowest to the highest risk. This classification helps determine the regulatory pathway and license required to launch your device.
Is the CDSCO MD 9 license application process online?
Yes, the CDSCO MD 9 license application process is online in the SUGAM portal.
