Medical Devices Registration

Medical device registration is a necessary and compulsory process in India that ensures that medical devices and in vitro diagnostics (IVDs) are safe and operate as per quality standards. The CDSCO (Central Drugs Standard Control Organisation) is the main regulatory body that looks after the approval and monitoring of devices across the country.

The medical device registration process in India helps bring safe and effective medical products into the market, thereby protecting public health. As the demand for the healthcare sector is increasing, both domestic and international manufacturers and importers are required to obtain the CDSCO medical device registration before selling any of their products.

India's medical device registration aligns with global standards such as FDA registration for medical device manufacturers and European CE marking. This registration gives Indian manufacturers access to the international market, thereby increasing global trade. The medical device approval process depends on the medical device classification, which is Class A, B, C, and D, all of which are based on risk factors. Compliance with these provides safety, transparency, and reliability to the patient in the medical device sector.

Role of CDSCO

The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory authority for pharma, medical devices, and cosmetics. It works under the Ministry of Health and Family Welfare, ensuring that all products, devices, drugs, and everything it deals with are safe, secure, and reliable for use, and are correctly manufactured under the global quality standards.
But when the work purely comes for medical devices, this is the main authority that does the medical device registration process in India. 

Key roles of CDSCO:

• CDSCO helps in medical device classification so that proper registration is done.
• It reviews each medical device registration application to verify that it is safe, what its intent is, and whether it is compliant with laws.
• This medical device license provides for manufacturing, importing, and selling the devices.
• CDSCO inspects domestic and international facilities to ensure that Good Manufacturing Practices (GMP) are followed.
• Once approval and license are obtained, CDSCO continues to check if there are any quality issues with the medical device.

What is a Medical Device?

A medical device is an instrument, machine, implant, diagnostic tool, or software that prevents, diagnoses, treats, or monitors a medical condition or disease. Medical devices do not function like medicines; they work physically or mechanically, but rather chemically. Examples include syringes, pacemakers, blood pressure monitors, stents, orthopaedic implants, X-ray machines, and surgical instruments. Medical device registration in India is very important, it ensures that these devices are reliable, effective, and safe for patients.

CDSCO medical devices registration offers numerous benefits that manufacturers, importers, and patients can benefit from. Some of its key advantages include:

• Registration confirms that a device is thoroughly tested, safe, and reliable, reducing the risk.
• This medical device registration certificate demonstrates that the device complies with all Indian rules and regulations, avoiding penalties.
• Devices with medical device registration gain easier market access to sell and distribute their devices.
• CDCSO medical device registration enhances credibility, leading to global recognition.
• Hospitals, clinics, and other healthcare centres prefer to use only CDSCO-verified medical devices to avoid tarnishing their reputation in the market.
• When proper regulations are followed, manufacturers and importers will be able to focus on new technologies and innovation.
• Registered medical devices can compete globally, boosting exports.

The requirements for India medical device registration are:

• Compliance with Indian medical device regulations and CDSCO guidelines.
• Details of manufacturing facilities and production units.
• Regulatory certificates like FDA approval, CE marking, ISO 13485, and Free Sale Certificate.
• Proper labelling and packaging as per Indian standards.
• Payment of CDSCO medical device registration fees.

Who Can Apply for CDSCO Medical Device Registration in India?

The following entities can apply for CDSCO medical device registration in India:

• Domestic manufacturers of medical devices and in-vitro diagnostics (IVDs).
• Importers of medical devices, IVDs, or cosmetics.
• Foreign manufacturers of medical devices and IVDs.
• Authorised agents representing foreign manufacturers.
• Indian subsidiaries of international medical device companies.

CDSCO classifies medical devices into four categories based on risk:

• Class A: Low-risk devices such as thermometers, stethoscopes, or bandages. Class A medical device registration is simpler and requires fewer documents.
• Class B: Low to medium risk, including blood pressure monitors, hypodermic needles, and suction equipment.
• Class C: Medium to high risk, such as ventilators, orthopaedic implants, and dialysis machines. These require more detailed safety data.
• Class D: High-risk devices like heart valves, stents, pacemakers, and defibrillators. The approval process is strict with clinical data and inspections.

Understanding this classification is the first step in the medical device approval process in India, as requirements vary for each class.

To register medical devices with the CDSCO, some documents must be submitted. The main documents are:

• Covering Letter
• Constitution of the Firm
• Establishment/Tenancy Agreement
• Plant Master File (general content)
• QMS Compliance Undertaking
• Device Master File (general sections)
• Test License
• Fee Challan

The medical device registration process in India involves four major steps:

• Classification of Devices

First, it will have to be ascertained which category the device falls into, Class A, B, C, or D. The applicant will have to provide all the details of the composition, manufacturing process, the intention behind using this device, and regulatory certificates. If clinical trials have been conducted, then the data from the same will also have to be attached.

• Online Application Submission

Manufacturers or authorised agents will need to submit this application through the CDSCO portal. The application must include all documents, labelling details, and any registration fees.

• CDSCO Review and Inspection

Now, CDSCO will carefully examine everything to ensure that the device is safe, performs well, and is effective enough. CDSCO will review all documents, inspect the manufacturing unit, and consult experts to determine whether the device complies with Indian standards and global standards, such as the FDA medical device registration database.

• Approval or Rejection

If the device meets all safety and regulatory standards, CDSCO approves registration. If not all requirements are met and the application is rejected, CDSCO will thoroughly explain the reasons for the rejection.

The fees for medical device registration depend on the device classification and license type. For example, if the device falls under Class A devices, then its fees will be comparatively lower than Class D medical devices, because Class D involves very detailed testing and inspection, as the chances of risk in it are very high. The fees also depend on the license that we are taking: a manufacturing license, an import license, or a renewal license.

A medical device certificate stays valid for five years from the date of issue. The registration certificate is not renewed, but retention is required to keep the certificate active for future use. Retention means that the work, whether it is manufacturing or importing the medical device, can continue without any break. If retention is not done on time, then penalties are charged. During payment of government retention fees, the applicable penalty amount also gets added and must be paid along with the fee. Payment of retention fees helps maintain approval and ensures that the medical device stays legally registered in India. So, timely retention protects the business, avoids penalties, and supports smooth operations in the Indian medical device market.

Timeline of Medical Device Registration Certificate

The time to get a medical device registration certificate may vary depending on many factors. Key points that affect approval include the class of the device, how complex the device is, the completeness of submitted documents, and the type of application, whether it is for manufacturing, importing, or a test license. Expected Approval Duration: 

• Class A & B Devices: These devices are low-risk, so approval is faster.
• Class C & D Devices: These high-risk devices need detailed safety and performance checks, so evaluation takes longer.

If documents are incomplete or have errors, authorities may ask questions, which can delay the process. Usually, approval takes around 4 to 9 months, but the exact time depends on the device type and the CDSCO workload at the time.

Corpseed is one of the top consulting firms, offering comprehensive assistance in the medical device and pharmaceutical compliance, guiding businesses through the necessary processes. We help manufacturers, importers, and distributors understand the rules of CDSCO medical device registration and make the process smooth, fast, and hassle-free.

How Corpseed helps in Medical Device Registration:

• Expert Guidance: We provide full support for the medical device registration process in India.
• Documentation Help: We prepare and organise all required documents like ISO certificates, labelling details, and manufacturing information.
• CDSCO Application Filing: We manage the entire application process on the CDSCO portal to avoid errors and delays.
• Regulatory Compliance: We ensure compliance with Indian laws as well as global standards like FDA registration, medical device manufacturer, and CE certification.
• Classification Assistance: We help identify the correct class (A, B, C, or D) for devices to meet approval requirements.
• End-to-End Support: From initial consultation to approval and renewal, we provide complete support throughout the registration journey.