Are You Looking For Medical Device Registration?

Connect with us for obtaining manufacturing license, import license, and test license for your medical device on time. With our expertise, we submit precise documents and application that helps us to get registration on time.

Medical Device

Medical device industry is growing extraordinary over the recent time, becoming most promising for businesses in healthcare. At the same time safety and efficacy of medical device is highly required because of it’s role in diagnosis, prevention, and treatment of disease.

We are authorized agent for medical device registration in India, having in depth knowledge of local and International regulations. Resolving challenges of regulatory authority for medical device can be complex but with right guidance, it can become easy.

Our Medical Device Services

We provide complete support and guidance for medical device registration in India, ensuring regulatory compliance with quality and safety standards. Our experts team simplify the process of registration from initial classification of medical device to securing registration in following steps:

Medical Device Classification

We help our clients identify the class of medical device (A, B, C, & D) based on the potential risk and intended use, ensuring precise regulatory compliance with local and International regulations.

Preparation of Technical Documents

Technical documents are required for medical device registration, having information about manufacturing process, quality documents, process control, and safety of medical device.

Clinical and Non Clinical Study Reports

We prepare both clinical and non clinical evaluation report for all classes of medical device, demonstrating performance of medical device and in vitro diagnostic devices.

Pre-QMS Audit Support

ISO 13485 compliance is prerequisite for medical device registration in India. Our experts team provides guidance and support in preparing QMS audit, ensuring your processes meets regulatory standards.

Regulatory Submission to CDSCO

We handles regulatory submission of documents for product registration to Central Drug Standard Control Organization (CDSCO) and ensure timely follow up for seamless approval.

Grant of Registration Certificate

Once the process gets successfully executed, We guide you through obtaining registration certificate, enabling your product gets market access on time, avoiding any delays.

CDSCO Medical Device Registration Made Easy

CDSCO is the regulatory authority of India responsible for regulation of medical device, pharmaceuticals, cosmetics, and many more for safeguarding the public health. The regulatory framework ensures that each and every medical device, whether diagnostic device or surgical medical device, it must be thoroughly evaluated for safety and efficacy before getting market access. We are here to make this complex process of regulatory compliance easy with our expertise and knowledge of medical device registration process. We guide you through each step of registration process, focusing mainly on being adherence with regulatory standards.

Our expertise includes:

Medical Device Registration
Technical Documents Preparation for Medical Device
Device Master File Preparation with Compliance
Plant Master File Preparation
Regulatory Submission of Medical Device and IVDs
SUGAM Portal Registration
Manufacturing License Grant for (A, B, C, and D) Class of Medical Device
Import License
Test License

Let’s Collaborate For Success

Simplify your medical device registration process in India with Medwisdom Lifescience. With our expertise and qualified experience team of experts let’s make the process easy and compliant. Connect with us today to ensure your medical device meets regulatory standards and reaches market faster. Let’s bring your products to local and International markets and improve the quality of care worldwide!

What Our Clients Think About Us

Biobee General Manager

As a General Manager, I highly recommend MedWisdom LifeScience Regulatory Services. Their expertise in navigating medical device regulations has been invaluable to our operations.

imperial Lifesciences Head Regulatory Affairs

Company services are excellent for CTD compliance and medical devices. Their expert team offers tailored solutions and efficient support. Highly recommended!

Genes2me Director

MedWisdom LifeScience Regulatory Services is a top choice for medical device companies. Their expert team offers tailored solutions to navigate complex regulations, ensuring compliance and efficient approvals. Professional and reliable, they are an invaluable partner in the regulatory process.

Frequently Asked Questions

Why medical device registration is necessary?

Medical device registration process is important to ensure your device meets all the required standard of safety and quality requirements of regulatory authorities. It helps to protect patients health and well being, while enabling legal compliance for manufacturer or business owners.

What are the documents required for medical device registration in India?

Below are some of the common documents required for any class of medical device registration in India:

Device description and classification
ISO 13485 certificate
Technical documents file or dossier
Clinical evaluation report
Laboratory testing report
Labeling and packaging details

What is the timeline for medical device registration?

The timeline for grant of medical device registration depends upon the nature of license and classification of medical device. The most common timeline for medical device registration from CDSCO is approximately 9- 12 months based on the category of medical device.

Can foreign manufacturer register medical device in India?

Yes, foreign manufacturer can register medical device in India, but they must hire authorized agent in India for medical device registration like Medwisdom Lifescience, who are aware of rules and regulations of CDSCO.