Medical Device Approval Process in India

The manufacturing of medical equipment is one of the most thriving industries in India. However, physicians and medical experts need to know more than simple manufacturing procedures.

It is equally pertinent for hospital facilities and private clinics to familiarize themselves with the medical device approval process. This is because each medical device requires an approval license before pushing its services into the market.

This article elucidates all you need to know about the medical device approval process in detail. Keeping reading to know more about it.

What is Medical Device Process Approval?

Medical device process approval refers to certain steps that medical practitioners must follow while procuring suitable medical and healthcare equipment for their facilities.

It comprises the stage by stage procedures to acquire the necessary license to catalyze the operational dynamics of their devices. Each hospital needs to follow certain medical protocols and conditions of compliance to get their devices regulated and approved.

This helps them maintain a healthy and secure ecosystem for their equipment and escalate their brand credibility among the patients.

Enforcement of Medical Device Approval Process

The approval process for medical devices came into the picture in January 2018-2019 with Central Drugs Standard Control Organization (CDSCO), a regulatory body under the Ministry of Health and Family Welfare overviewed and implement stringent protocols for permitting the smooth functionality of medical devices in India.

This eventually led to the formulation of policies and procedures to fuel their monitoring dynamics and facilitate the effortless procurement and use of medical equipment in the country.

Step-by-Step Procedure of Medical Device Approval Process

To comprehend it further, here is a step-by-step procedure enforced by CDSCO.

Step 1: Understand the Regulatory Framework

First and foremost, medical practitioners should grasp the complete procedure involved in the medical device approval process. In this, they need to examine the entire list of their medical equipment and check the sections in which they fall.

This is because CDSCO sanctions the approval of devices as per their exhaustive catalog and thus, physicians need to ensure the category of their procurable devices.

Furthermore, they should also check the devices as per other regulations forwarded by Drugs and Cosmetic Rules, Medical Devices Rules, and other Gazette notifications and reviews before issuing the final device regulatory status.

Step 2: Interact with an Authorized Agent

Next, doctors need to appoint an authorized agent for further procedures. The key role of this agent is to communicate with CDSCO and on your behalf and do the prerequisite paperwork.

Generally, the hospital facilities need to fill forms 20B and 21B/C to ensure to manage their registration and pave the way for smooth importation of their medical equipment to India.

Step 3: Robust Performance Testing

Procurement and approval processes remain incomplete without robust performance testing of the pharmaceutical drugs and medicines. In fact, drugs belonging to classes B, C, and D. ICD require regulatory permission from the National Institute of Biologicals (NIB) for further processing.

This is because the Indian markets require the production of authentic performance results from accredited test labs in India. This makes the physicians highly competent and focused while following the approval procedures.

Step 4: Checking Pertinent Specifications

Besides the above, medical practitioners must also check other device-related information to smoothen the medical device approval process.

This includes scrutinizing the ISO certification of the medical equipment, compile device applications (Form: MD-14), testing results, IFU, clinical data, its approval status in other countries such as the USA, UK, Australia, Canada, etc.

Step 5: Filling the Application Form

Ensuring the timely completion of the aforementioned steps, doctors should finally take a step forward to fill the application forms along with the supporting documents.

Therefore, apply the English language with CDSCO and pay the requisite processing charges to finalize your medical device approval process.

Step 6: Application Review

Post the submission of forms, the Subject Expert Committee under CDSCO will review your application before approving your device status. For this, you are required to deliver a presentation and attend a personal meeting with CDSCO officials.

Step 7: Post Approval

Post the approval of your medical device status, your authorized agent in India can import products. Besides, you can also take multiple registrations import licenses through different authorized agents for the same medical devices.

So this is the complete procedure for getting official approval for your medical devices. Hospital facilities and private clinics must adhere to these protocols and follow them judiciously.

ZEPNURhealth ushers all doctors and healthcare specialists to go through this article and understand the entire process. We are a medical and healthcare equipment company in Bangalore.

We aim to furnish medical and healthcare equipment solutions to our clients across India at affordable prices. Log in to to know more about our procurable items.

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