Apply For Medical Device Registration In India

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Medical device registration is a crucial process that ensures medical devices’ safety, efficiency, and quality. It is done before it can be marketed and used by healthcare professionals and patients. To obtain this license you have to go through a series of regulatory steps to meet the medical contraption required standards set by the regulatory bodies. Here you will learn about the deep knowledge of medical device registration in India, its steps, importance & other understanding.

What Is Medical Device Registration?

Medical Device Registration is the legal process by which manufacturers obtain approval to market & Distribute medical devices. It is mandatory for the specific country or region as per the government’s regulatory guidelines. The process is regulated by multiple regulatory agencies according to countries such as the FDA in the United States, the European Medicines Agency (EMA) in the European Union, and other regulatory authorities worldwide.
In India, the medical device regulatory guidelines and registration are issued by the CDSCO (Central Drugs Standard Control Organization). If you are dealing in the indian market the CDSCO registration for importers and manufacturers is mandatory according to your business.
The primary aim of medical device registration is to ensure that all medical devices are safe for use and function as intended.

What is the Importance of Medical Device Registration?

Understanding the importance of medical device registration is very mandatory for all manufacturers & importers. It plays a very crucial role in preventing substandard or harmful medical devices from entering the market. The key benefits of registration of medical devices include:

Safety Assurance: Ensures devices are safe for patient use.
Quality Control: Guarantees high standards of manufacturing and performance.
Regulatory Compliance: Ensures compliance with local and international regulations.
Market Access: Facilitates legal access to domestic and international markets.
Consumer Confidence: Enhances trust among healthcare providers and patients.

Which Government Body Issues Medical Device License In India?

In India, Medical device regulation is administered by the CDSCO (Central Drugs Standard Control Organization). CDSCO authority is managed under the Directorate General of Health Services in the Ministry of Health & Family Welfare.

CDSCO is stated as a National Regulatory Authority (NRA) of the of INDIA. For the registration of medical devices in India, a non-local company must appoint a local agent or consultant who deals with the regulatory compliance services for the CDSCO Registration.

What Are The Medical Device Regulations Rules?

In India, you have to register medical devices as per the Indian regulatory laws. The Medical device regulations are:-

What Are The Medical Device Registration Requirement In India?

Manufacturers or importers that are interested in medical device registration must submit the documentation for the proof in the home market. It is mandatory to submit the application or documents to the CDSCO body for approval. If you want seamless manufacturing of medical devices then you must register an application for all your medical devices.

Procedure Of Medical Device Registration In India

For effective medical device registration in India, you must follow the necessary steps. Without following these steps it is quite difficult to obtain the CDSCO License for medical devices. The steps are as follows:

Classification Of Medical Devices

Medical devices are classified into different categories based on their risk level. The classification of devices varies per country but it generally includes such as

Class A (low risk)
Class B (Lower to Moderate Risk)
Class C (Moderate to High risk)
Class D (High risk)

It is crucial to determine the product category first to meet the regulatory requirements & process of the CDSCO registration in India

Pre-Market Approval

If any of the manufacturers or importers is dealing in high-risk medical devices you must require Pre-Market Approval (PMA). The PMA includes submitting extensive clinical data and evidence to determine the safety and efficacy of products. The CDSCO regulatory body reviews the data and decides whether the devices can approved in the market or not.

Quality Management System (QMS)

For the manufacturers of medical devices implementing a robust Quality Management System (QMS) is essential. The QMS should comply with international standards such as ISO 13485, which outlines the requirements for a comprehensive quality management system in the design and manufacture of medical devices.

Technical Documentation

Manufacturers must contain and submit technical documents such as design specifications, manufacturing processes, clinical data, and risk assessments. These documents work as evidence that the devices meet all the regulatory requirements.

Clinical Evaluation

A clinical evaluation involves assessing the clinical data related to the device to ensure its safety and performance. This may include clinical trials, literature reviews, and post-market surveillance data.

Regulatory Submission

Once all the necessary data and documentation comply the manufacturer must submit their registration application to the regulatory authority (CDSCO). This submission includes detailed information about the device, its intended use, clinical data, and proof of compliance with applicable standards.

Review and Approval

The regulatory bodies will review the submitted application and confirm that the device meets all the necessary safety and performance requirements. This process can involve multiple rounds of questions and additional data requests. Upon satisfactory review, the device is approved for market release.

Post-Market Surveillance

After the approval, the manufacturer must conduct the Post-Market Surveillance. It is necessary to monitor the performance and safety of the device in the real world. This helps identify any potential issues and ensures continued compliance with regulatory standards.

How Are Medical Devices Classified In India?

As per the CDSCO guidelines the the medical devices are classified in the market for registration according to their risk factor. The indian classification of medical devices is similar to the EU MD Classes.

What Are The Timelines for Medical Device Registration Approval?

The medical device approval or whole process usually takes 6 to 9 months. If you are dealing with a new product without any strong prediction then the registration of the product must take a long time.
The license of the medical device is valid for 5 years and after that, you have to pay a fee to renew the license.

What are the Classifications of Forms for Existing Medical Devices?

Applicant	Risk/Class	Type Of License	Form
Importer	A,B,C,D	Importer License	Application MD – 14 Permission MD – 15
Manufacturer	A, B	Manufacturer License	Application MD – 3 Permission MD – 15
		Loan License	Application MD – 4 Permission MD – 6
	C, D	Manufacturing License	Application MD – 7 Permission MD – 9
		Loan License	Application MD – 8 Permission MD – 10

What are the Classifications of Forms for New Medical Devices?

Applicant	Risk/Class	Type Of License	Form
Importer	A,B,C,D	Clinical Investigation Permission	Application MD – 22 Permission MD – 23
	A, B, C, D	Import License	Application MD-26 Permission MD-27
	A, B, C, D	Test License	Application: MD-16 Permission: MD- 17
Manufacturer	A, B, C, D	Clinical Investigation Permission	Application: MD-22 Permission: MD- 23
	A, B, C, D	Manufacturing License	Application: MD-26 Permission: MD- 27
	A, B, C, D	Test License	Application: MD-16 Permission: MD- 17

How can ELT Corporate help you with MDR CDSCO Certification?

We will check under which Class your product will fall, including whether your product complies with the CDSCO standards. Getting a CDSCO certificate is no piece of the cake, but our team at ELT Corporate will analyze the product requirements thoroughly to give clear and practical guidelines. We are equipped with all the essential resources to conduct a virtual pre-audit to confirm if your manufacturing unit complies with CDSCO requirements.

You can expect reliable and punctual service delivery as we will also visit the CDSCO office on your behalf if required. Our IMDR CDSCO consultants will invest their sustained efforts to meet your queries or demands of concerned authorities. In case of any concern regarding the CDSCO license, we assure to provide the best possible solution concerning medical devices CDSCO registration. Our CDSCO consultants will coordinate with the concerned authorities for regular follow-ups.

We at ELT Corporate, possess the required resources and team of experts to help obtain an import license for foreign or Indian manufacturers. We are well versed with the new Medical Device Rules formulated by CDSCO and provide end-to-end service and support to our clients.

Rohini, New Delhi-110085

+91 9899997002