How To Apply Manufacturing License For Medical Device In India?
If you are a manufacturer or distributor looking for a manufacturing license for your Medical Device, this guide will help you to simply understand the documents and procedure of obtaining manufacturing license for medical device in India. Manufacturing license is issued by the licensing authority of India. Classification of medical device determines which licensing authority is responsible for issuing manufacturing license. State licensing authority is responsible for grant of manufacturing license for class A and B medical device. Central licensing authority is responsible for issuing manufacturing license for class C and D medical device based on the risk it possesses. This guide will help you to figure out your queries for obtaining manufacturing license for medical device in India.
Who Can Apply For Manufacturing License For Medical Device?
Below are some individuals who can apply for manufacturing license for medical device in India:
- Manufacturer: who is responsible for production and manufacturing of medical device can apply for manufacturing license.
- Importer: Person who is looking to Import medical device in India can apply for manufacturing license.
- Distributor or Authorized Person: Person who is authorized from manufacturer can apply for license.
What Is Medical Device? How Many Classes Of Medical Device Are there?
Medical device is any instrument, equipment, implant, or machine that is used in diagnosis, treatment, and mitigation of disease in humans. Medical devices are classified into four types based on the risk it possesses:
- Class A: Low risk medical device (stethoscope and bandages)
- Class B: Intermediate risk (syringe and glucose meter)
- Class C: Moderate high risk (catheter and implants)
- Class D: Very high risk (heart valves)
Documents Required For Obtaining Manufacturing License For Medical Device In India
For the grant of manufacturing license for your medical device, following are some key documents required as per CDSCO guidelines:
- Application Form: Form MD-3 is filled for class A and B medical device, form MD-7 for class C and D medical devices.
- Plant Master File: Plant master file having information about the manufacturing site, layout of facility, and equipment used.
- Device Master File: Detail description of medical device and risk possibilities along with the specifications and design.
- Quality Management System: QMS certificate issued under ISO 13485 certification demonstrating high performance quality standard of medical device in compliance with regulatory framework.
- Technical Documents: Most important documents including product specifications, clinical report and risk management plan of medical device.
- Stability Data: Stability data demonstrating the shelf life of medical device.
- Declaration or Undertaking: Undertaking from manufacturer, ensuring compliance of medical device with regulatory standards.
- Labelling and Packaging: Details of labelling for medical device is required as per Medical Device Rules, 2017.
Procedure To Obtain Manufacturing License For Medical Device
Following are the main steps for the grant of manufacturing license:
- Visit Sugam Portal: Register on the CDSCO/sugam portal by creating an account.
- Application Submission: Select the Form applicable as per your medical device class. Fill the form details carefully and submit on the portal.
- Fee Payment: Pay the applicable fee as per the Medical Device Rules, 2017.
- Audit Inspection: Specific regulatory authority will conduct the inspection of product manufacturing site, to ensure the compliance of medical device as per the regulatory standards.
- License Issuance: After the successful evaluation of manufacturing site along with your application form documents, Licensing authority will grant the manufacturing license.
How Medwisdom Lifescience Can Assist You With Obtaining Manufacturing License?
Medwisdom offers expert assistance in medical device registration and license, we have secured over 2500 medical device registration so far, we take pride in our exclusive achievement for grant of 500 plus manufacturing license across all classes of medical device (A to D). Our expertise ensure timely registration and cost effective solutions for obtaining manufacturing license.
FAQs
Any company or individual planning to manufacture medical device for the purpose of sell or marketing, must obtain the manufacturing license for medical device under the Medical Device Rules, 2017.
State Licensing Authority is responsible for issuing manufacturing license for class A and class B medical device. Central Licensing Authority is responsible for class C and class D medical device.
Validity of manufacturing license is five years from the date of issue.
The approximate time for obtaining manufacturing license for medical device takes 5-6 months, based on the completeness of your application and the response from the regulatory authority.
