MDR CDSCO REGISTRATION

Medical Devices Rules (MDR) 2017, governed by CDSCO Registration, aims to ensure that medical devices in India are marketed safely and effectively. The registration of the organization is done according to the guidelines issued by the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices Rules, 2017. Registration adds value by establishing legitimacy, following regulatory compliance, and ensuring public safety for successful and long-term strategizing in a competitive market.

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Service Overview

Under MDR, it is mandatory for medical device manufacturers to register with the CDSCO before marketing their products in India. Our expert team will provide comprehensive documentation, regulatory compliance, and a seamless approval process, allowing your business to successfully enter the Indian market for medical devices. The detailed procedure involves thorough benchmarking of your device's design safety features against national and international standards.

‍Challenges of Filing for a Private Limited Company

Complex Procedures

The formation of the private limited company is quite complex as it requires many legal formalities.

Time-Consuming

Sometimes, its exhausting to gather all the necessary papers and fill out all necessary documents.

Share Limit

In a Private Limited Company there is a limit of 200 shareholders, with a restricted limit on share transfers.

Business Commencement

Within 180 days of registering a Private Limited Company, the certificate of commencement of business must be obtained.

‍Challenges of Filing for a MDR CDSCO Registration

Complex set of submissions

Delays can occur due to incorrect documentation, as the registration process requires extensive paperwork, which shows the need for careful and complete preparation.

Understanding Guidelines for Regulations

For a company, keeping up-to-date, tracking and implementing the updates in regulations of CDSCO can be overwhelming and not complying with them can result in fines without the help of CDSCO experts in India.

Time-Consuming Approval Process

The registration process involves several stages and a serious review, which can thus create time delays; therefore, a structured approach is very significant to avoid such obstacles.

Ensuring Technical Compliance

Every device needs specific technical and safety criteria, but it also needs technical understanding and careful compliance that requires the intervention of an expert to smooth the approval process.

Advantages Of MDR CDSCO Registration

Enhanced Access to Markets

The CDSCO registration serves as an entry to the medical device market that is witnessing growth and opportunity in India. It thus places your product in the good books of reliability with respect to the healthcare providers.

Regulatory Compliance Guarantees

Registration proves you have your medical device in compliance with all regulations and therefore minimizes the risk of legal action or withdrawal from the market. Compliance lets you concentrate on innovating and improving quality.

Trust Comes to the Stakeholders

Compliance with the CDSCO standards raises the trust of customers, healthcare practitioners, and financiers, thus adding to your reputation in the marketplace. Such trust directly contributes positively to your sales and brand equity.

Competitive Edge Acquired

Approval for manufacture and sale puts the medical device well ahead of its competition; compliance stands for your commitment to quality and safety. This also establishes strong brand recognition as a marker of product reliability.

Service Process

01

Medical Device Classification Review

We begin by classifying your product under CDSCO's medical device rules to determine the applicable regulatory requirements and documentation paths.

02

Importer Authorization (if applicable)

For imported devices, we help to arrange for the authorization letter required by the overseas manufacturer to comply with CDSCO mandates.

03

Documentation Preparation

In this regard, our team helps compile and review essential documents, ensuring the documents are accurate and in accordance with the CDSCO provisions.

04

Application Submission

We take care of the application processes with submission to the concerned regulatory authority for further review and approval. Timely submission works towards minimizing the unnecessary delay of approval.

05

Follow-Up Communication

We maintain constant communication with CDSCO so that any queries may be addressed, which helps expedite the review. We believe in a proactive approach that ensures smooth communications with the authorities.

06

Approval and Certification

Upon successful review, we ensure that the registration certificate is duly issued and on time so that your product can enter the market. After the approval, we will provide support for addressing all other requirements.

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Service Process

Consultation

We will have a consultation regarding your business vision and requirements to decide on whether the private limited company fits you well.

Documentation

We will help you to do the paperwork involving preparation of the Memorandum of Association and Articles of Association.

Registration

We will then forward all the necessary documents to the Registrar of Companies as required for registration.

Support

We will always be here with you to offer assistance and advice so that you can efficiently run your private limited company.

Compliance:

We will assist you in maintaining a continuing compliance with all legal and regulatory standards.

Service Process

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Service Breakdown

Eligibility

Indian Manufacturers: Must comply with CDSCO’s defined technical and safety guidelines. Compliance is mandatory for gaining market access and establishing product reliability.

Foreign Manufacturers: Should appoint an authorized Indian agent for registration purposes, to facilitates seamless communication with CDSCO and ensures adherence to local regulations.

Approved Devices: Applicable to devices listed under CDSCO’s notified categories. Devices outside the notified categories require special approvals.

ISO compliance: Products must be relevant to the ISO certification regarding quality. Compliance with that standard implies globally accepted and marketable products.

Documents

Business Incorporation Certificate: Validates the application under operation as a registered medical device manufacturer, importer, or distributor.

Manufacturing License or Import License: Licensing qualifications for medical devices produced or imported.

Device Master File (DMF): Contains technical specifications, use case, and safety data of the medical device.

Quality Management System Certificate (ISO 13485): Affirms that standards regarding the quality of medical devices are upheld.

BIS or CE Certification (if applicable): Ensures the medical device meets Indian or international safety standards.

Who Needs

Medical Device Manufacturers: Required for businesses producing medical devices for distribution in India. Manufacturers must ensure compliance with CDSCO’s stringent quality and safety norms to establish credibility.

Importers of Medical Devices: Mandatory for importing and selling medical devices in India. Importers must provide detailed product information and appoint authorized representatives to handle regulatory submissions.

Healthcare Institutions: Ensures devices meet safety standards for patient care. Compliance ensures the devices used align with national healthcare safety standards, safeguarding patient welfare.

Distributors and Retailers: Needed for selling registered medical devices in compliance with regulations. Proper registration prevents legal issues and enhances the distributor’s and retailer’s credibility.

Creating

Trust-Driven Relationships

JR Compliance is one of the known name for BIS certification, they are well versed with processes and guide client properly.

Kartik Shah

Published on 4 March 2024

We have outsourced the entire BIS certification responsibility of our panels to JR compliance since 2017 and their service so far has been exemplary.

P N Dhawanjewar

Published on 4 March 2024

We have been using JR Compliance services since last 3 years on various BIS related registration & testing of our various IT & electronic products. We really appreciate your full-fledged & excellent support in all respect in this matter.

K Narayanan

Published on 4 March 2024

FAQ

What is MDR CDSCO registration?

It is an obligatory process to ensure the conformity of a medical device with the regulatory standards in India for safety and efficacy, thus promoting trust and legal market distribution.

How long does the registration procedure take?

It varies but, in general, can take anywhere between 3-6 months, depending on the accuracy of documentation presented and the time taken by regulators to respond. Timely preparation of documents will lead to timely processing of applications.

Is CDSCO registration applicable to all medical devices?

Not all devices require registration. It applies to notified devices listed under CDSCO’s regulatory framework. Verification of device classification is crucial.

Can foreign manufacturers apply directly for registration?

No, a foreign manufacturer should appoint an authorized agent in India, who will apply for registration on his behalf, to ensure compliance with the Indian regulatory norms.

What would happen to a device if it is not registered?

Selling an unregistered device in India is illegal; this may lead to a penalty, market withdrawal of the device, or legal recourse. Proper registration maintains legalized conduct and market credibility.

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MDR CDSCO REGISTRATION

Service Overview

‍Challenges of Filing for a Private Limited Company

‍Challenges of Filing for a MDR CDSCO Registration

Advantages Of MDR CDSCO Registration

Service Process

Service Process

Service Process

Comprehensive support throughout the registration process, ensuring seamless navigation of regulatory requirements.

Experienced team specializing in MDR CDSCO compliance with in-depth industry knowledge and expertise.

Transparent and client-focused approach, keeping you informed at every step for complete clarity.

Proven track record of successful registrations, guaranteeing reliable and efficient service delivery.

Why Choose JR Compliance?