Central Drugs Standard Control Organization (CDSCO) is the apex regulatory body for all medical devices in India. The CDSCO MD5 license grants the permission to manufacture class A and B medical devices in India. Class A and B medical devices are low to moderate risk devices. Hence, they undergo less scrutiny. However, Class A and B medical devices must comply with all applicable Indian medical devices regulations. Additionally, the MD 5 license has to be secured to manufacture Class A and B medical devices in India. We have prepared this detailed guide to help you easily get the CDSCO MD5 manufacturing license in 2026. We have mentioned every detail from complete procedure to necessary documents for CDSCO MD 5 license application.
CDSCO medical device classification system
To get CDSCO MD5 manufacturing license, you need to first understand the 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 classification system is sorted from the lowest to the highest risk. The CDSCO medical device classification helps determine the regulatory pathway and requirements for licensing of medical devices in India. The manufacturer can fill in the registration and licensing paper work depending on the medical device class. CDSCO medical device classification list was prepared mainly for the ease of certification, registration, and licensing purpose. In this blog, we will focus on Class A and B medical devices only.
- Class A: Low-risk medical devices are grouped as class A. Examples: sphygmomanometer, gloves, elastic bandages, hot water bags, and walking aids
- Class B: Low to moderate-risk medical devices are grouped as class B. Examples: blood glucose monitoring devices, syringes, surgical instruments, nebulizers, and other diagnostic equipment
CDSCO manufacturing license for Class A and B medical devices
- Form MD 3: The application for CDSCO MD5 manufacturing license for class A and B medical device is filed under MD 3. The manufacturer will have to submit the Form MD3 to the state licensing authority to secure the CDSCO license to manufacture class A and B medical devices in India.
- CDSCO MD5 manufacturing license: The license to manufacture class A and B medical devices in India will be granted on MD 5.
State Licensing Authority (SLA) is responsible for granting CDSCO MD 5 license for manufacturing Class A and B medical devices in India.
Documents required to get CDSCO MD5 manufacturing license
We have provided an overview of the documents required for CDSCO MD5 manufacturing license application for class A and B medical devices.
- Organization identity proof, such as UDYAM Aadhar, PAN card, etc.
- Sale Deed/Rent Deed proving legal ownership of the manufacturing facility.
- 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.
- Documents proving the manufacturing team comprises competent, qualified, and experienced staff who will manufacture and test the medical devices.
- 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.
The above list provides an outline of the supporting documents required for applying for CDSCO MD 5 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.
A step-by-step guide to easily get CDSCO MD5 manufacturing license
We have prepared a detailed step-by-step guide to help you easily obtain CDSCO MD5 license for class A and B medical devices.
- Step 1: Correctly classify the medical device: The first step is to correctly classify the medical device according to CDSCO regulatory guidelines. Correct classification determines the applicable regulatory pathway. Check whether your medical device belongs to CDSCO class A or B, as this will determine whether a CDSCO MD5 manufacturing license will be required.
- Step 2: SUGAM portal login: Login or signup on the official online CDSCO medical device license application system, SUGAM.
- Step 3: Documentation 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 MD5 license application.
- Step 4: Fill in the application form correctly: Fill out the applicable CDSCO 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: Approval and licensing: If all the criteria are fulfilled, CDSCO will grant the MD 5 license. The CDSCO MD5 manufacturing license will permit you to manufacture class A and B medical devices in India.
Validity of the CDSCO MD 5 license
The CDSCO MD 5 license remains valid indefinitely unless cancelled or suspended. However, a license retention fee has to be paid every 5 years to maintain the validity.
Pharmadocx Consultants can help you easily get CDSCO MD5 manufacturing license
Our service covers the following:
- Correct classification of medical devices: We will help you identify the correct class for your medical device and ensure compliance with applicable requirements.
- License application support: We will oversee the CDSCO MD5 license application process. Our team has proven expertise in license application.
- Documentation 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 A and B medical devices in India.
- Mock audit support: Pharmadocx Consultants 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.
- Liasson between CDSCO and applicant: We will act as a liaison between you and CDSCO regulatory authorities. Our team will provide accurate and timely response.
- Post license grant support: Our service does not end with assistance for license application. We provide license application and document preparation support as well as assist in procuring the license. We will monitor the application process till the license is granted. Furthermore, we provide post licensing and renewal support.
Call/Whatsapp us at 9996859227 or drop an email at [email protected] to easily get CDSCO MD5 manufacturing license. Our team will provide tailored support depending on your needs and will guide you through the steps of the MD 5 license application process.
FAQs
What is CDSCO?
Central Drugs Standard Control Organization (CDSCO) regulates and controls medical devices, cosmetics, and drugs in India.
What is CDSCO MD 5 license?
CDSCO MD 5 license is required to manufacture Class A and B medical devices for sale and distribution in India.
What is Class A medical device?
Low-risk medical devices are grouped as class A. Examples: gloves, elastic bandages, hot water bags
What is Class B medical device?
Low to moderate-risk medical devices are grouped as class B. Examples: syringes, surgical instruments, blood glucose monitoring devices
Who grants the CDSCO MD5 manufacturing license?
State Licensing Authority (SLA)grants the CDSCO MD5 manufacturing license.
