The CDSCO (Central Drugs Standard Organization) is the regulatory authority in India that falls under the Ministry of Health Of India. The responsibility of the department is to keep an eye on Medical Device Registration In India. In India, medical devices are regulated as per the Drugs and Cosmetics Act, of 1940 (pre-independence legislation). After the implementation of the act the government has been reviewing and updating the laws to check all the technology advances in healthcare to accommodate medical devices in India. So to work as per the law and act of the Medical Device Rules 2017 you must be under the process of Medical Device Registration In India.

Here you will get to know about the purpose, documentation and how to apply for medical device registration as per the law of the Indian Medical Device Regulatory Authority CDSCO.

Introduction to Medical Device Registration in India

The medical device registration process in India is necessary to ensure that the devices used in healthcare are safe, effective and comply with national regulations. Registration is important because India’s healthcare sector is growing rapidly and this leading to an increase in the demand for medical devices. This will help to ensure the safety and quality of these devices. The government of India make sure that all the devices are registered with the Central Drugs Standard Control Organization (CDSCO) before they are sold and distributed in the country. The process ensures that the medical device industry meets the regulatory standards and regulations.

Which Regulatory Authorities Involved in Medical Device Registration?

The primary authority that is responsible for the medical device regulatory in India is the Central Drugs Standard Control Organization (CDSCO). The CDSCO department is managed under the Ministry of Health and Family Welfare. CDSCO body plays a vital role in the approval and control of regulation of medical devices in India. Additionally, the Drugs Controller General of India (DCGI) oversees the registration of medical devices and ensures that they comply with Indian regulations.

Types Of Medical Device Requiring License

Medical Devices In India are classified into four categories as per the risk level:

• Class A: Low-risk devices, such as tongue depressors and bandages.
• Class B: Moderate Risk Devices, such as infusion pumps and blood pressure cuffs.
• Class C: High-Risk devices, such as ventilators and defibrillators.
• Class D: Very High-Risk devices, such as implantable pacemakers and heart valves.

Each class of medical device have different requirements such as higher risk devices requiring more stringent documentation, testing, and approval processes.

What Is The Eligibility Criteria For Medical Device Registration In India?

To register for the medical device in India, the manufacturer must meet the specific criteria. After that they can simply go ahead with the process of medical device registration in India:

• The manufacturer must be a company or legal entity established in India or abroad.
• If the manufacturer is based outside India, a local Authorized Representative (AR) must be appointed.
• The medical device must be compliant with Indian standards, which may include adherence to international standards like ISO or IEC.
• Importers, distributors, or manufacturers must have valid Good Manufacturing Practices (GMP) certification and other relevant licenses.

Why Registration Of Medical Device In India Required?

The registration of medical devices in India is a legal necessity to gain consumer trust. It is required to show that the medical devices that are regulated in the market meet indian regulatory standards. This will help to boost the trust of the consumer and ensure that the product is reliable to use. So you must understand why it is required and what is the process of medical device registration in India. The reason for medical device registration is as follows:

• Safety Of Devices – By attesting to the device’s careful inspection and conformance to accepted safety standards, registration ensures patient safety.
• Market Access – By signing up, you can distribute and distribute your device lawfully in India. The marketplace is now open.
• Compliance – There might be harsh consequences, such as fines and jail time if your equipment is not registered.
• Reputation – A registered medical device enhances the credibility and reputation of your company by demonstrating your commitment to quality and patient safety.

Process Of Medical Device Registration [Step by Step Guidance]

When you apply for the application you must understand the process of medical device registration. An understanding of the process is necessary because without registration you are not allowed to regulate products in the indian market. This will help you to access the indian market without facing any kind of legal issues:

Check Your Medical Device Required Registration Or Not

As per the Drugs and Cosmetics Act, medical devices are classified into different categories. You must find the category of your product and figure out does it requires registration or not. Catheters, which are implants for the ears, and spinal injections are among the 22 devices that are governed. These devices must undergo registration with the CDSCO, with some exceptions granted by the DCGI through an NOC. This procedure takes four to twelve weeks. The effectiveness and safety of medical equipment are guaranteed by regulatory control, which improves healthcare in India.

Choose an Authorized Indian Representative

For legal reasons, foreign manufacturers operating in India need to designate a representative. This person helps with reports, registration, and approvals for devices. Manufacturers can appoint an authorized Indian agent, holding specific licenses, to register CDSCO on their behalf. The manufacturer remains the registration holder and can appoint multiple distributors across the country for efficient distribution.

Submit the Regulatory Documentation with Form 40

Here are the documents required with form 40, mentioned below:

• Form 40
• TR6 Challan
• Power of Attorney
• Schedule D1
• ISO 13485 certificate
• Full Quality Assurance certificate
• CE design certificate
• Declaration of Conformity
• Free Sale Certification
• Certificate of Marketability from GHTF countries
• Other regulatory approvals
• PMS Report
• Plant Master File
• Device Master File

The CDSCO charges a fee of US $1500 for registering a single manufacturing site and US $1000 for a single device family. The registration process typically takes between 6 to 9 months. However, if your products lack a predicate in India, the processing time may increase. In such cases, a special committee will assess the safety and efficacy of the products for the Indian market.

Secure Your Registration Certificate with Form 41

After submitting the documentation, the CDSCO will reach out to the Indian agent within approximately three months with their first query letter. Once they receive a response to the query, the CDSCO will either issue another query letter or grant the license. The registration certificate remains valid for three years.

Secure Your Import License with Form 10

To become a distributor, you’ll need to apply directly to the CDSCO using Form 10. Form 8 should be submitted with the application together with Form 9 (which includes the proof of registration number). Usually, this procedure takes four to twelve months.

Promotion In India

Your goods can be sold in India once you get an import permit and registration certificate. It is imperative that the authorized Indian agent rapidly notifies the CDSCO of any modifications, adverse occurrences, recalls in other countries, or other relevant information as they happen. By doing this, legal requirements are met, and the market’s integrity and safety are preserved.

Process Of Medical Device Registration – Important Points

• Device Classification: Firstly, group your medical equipment into the designated risk classes (Class A, B, C, or D). The amount of control and testing necessary is determined by the categorization.
• Selection of Authorized Representative: To be represented throughout the registration process if your place of business is not in India, you must select a designated representative (AR) who resides there.
• Submission of Application – The online government site is used to apply electronically to the Central Drugs Standard Control Organization (CDSCO), along with the required payments.
• Technical and Clinical Evaluation – To verify adherence to performance and safety criteria, CDSCO examines the paperwork. As part of the review process, they might ask for further details or visit the location.
• Approval and Registration – Following a satisfactory review, CDSCO authorizes registration. Once registered, the device is added to the National Medical Device Database and given an individual registration number.

When Apply For Medical Device Registration in India?

The timing of registration depends on the classification of your device and the intended market entry date. To prevent delays, it is recommended to start the process of registering well in advance.

What to Consider Before Applying For The Registration of Medical Device in India?

After understanding the process of medical device registration in India you must understand what to consider. It is necessary to understand the process, prices & time frame to obtain the license of medical device registration.

• Price: Device registration may be expensive, especially for Class C and D devices that need to be thoroughly tested and assessed.
• Timeframe: The registration procedure may take many months or even years, according to the device’s design and the completeness of the application.
• Legal consequence: In addition to additional legal ramifications, failure to comply with the registration requirements may result in fines, jail terms, and product recalls.

Conclusion – Process Of Medical Device Registration

It is a difficult but necessary registration procedure for medical devices in India to ensure the effectiveness and security of equipment used there. If you follow the in-depth procedures in this place, you may easily finish the registration process for Medical Devices and obtain access to the large Indian market.

Frequently Asked Questions