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In general, the timeline for medical device registration in India typically takes 6 to 9 months, depending upon the complexity of the applications.
Pre-Application Phase
Review & Inspection Phase
Approval & Certification Phase
Medical device registration is a mandatory requirement for all medical devices intended for sale or distribution in the Indian market. The Central Drugs Standard Control Organization (CDSCO) serves as India's regulatory authority, responsible for granting Medical Device Product Registration. CDSCO plays a crucial role in regulating the approval, distribution, and supervision of medical devices, pharmaceuticals, and other health-related products.
Any product covered under CDSCO regulations must undergo registration. However, the registration process is complex, requiring extensive testing and assessments to ensure quality, safety, and efficacy. Additionally, foreign manufacturers seeking medical product registration in India must appoint a local agent or manufacturer to interact with CDSCO and ensure regulatory compliance.
In India, medical devices and equipment are regulated under the Drugs and Cosmetics Act, 1940, along with the Medical Device Rules (MDR), 2017, which were later updated as the Medical Device (Amendment) Rules, 2020. To simplify the process of medical device registration in India, talk to Corpfilings experts.
The list of classifications of medical device registration in India according to the Central Drugs Standard Control Organization (CDSCO) is given below:
Class A medical devices pose minimal risk to patients. These are non-invasive and come into contact only with intact skin.
Examples: Bandages, surgical masks, examination gloves, tongue depressors, etc.
Class B medical devices present a low to moderate risk. While not life-threatening in case of malfunction, they may come in contact with intact mucous membranes.
Examples: Hypodermic needles, suction equipment, aerosol nebulizers, etc.
Class C medical devices pose significant risks if they malfunction, potentially causing serious harm or injury. These devices are invasive and may enter the body through natural orifices or make contact with internal body fluids.
Examples: Artificial heart valves, orthopaedic implants, catheters, intraocular lenses, etc.
Class D medical devices carry the highest risk and can cause severe harm or death if they fail. They are invasive, often coming into contact with the cardiovascular system, central nervous system, or used for life support and sustenance.
Examples: Pacemakers, defibrillators, implantable stents, ventilators, heart-lung machines, etc.
The different types of medical device registration are given below:
Any Indian entity intending to import medical devices from a foreign country must apply for a CDSCO import license using Application Form MD-14.
An Indian entity that wants to manufacture and sell medical devices in India must apply for a CDSCO medical device manufacturing license using Application Form MD-3 or MD-7, depending on the device category.
Ensure CDSCO compliance, build trust, and enter the Indian market with CorpFilings' expert assistance. We simplify the Medical Device Registration process by handling documentation, approvals, and regulatory compliance so you can focus on growing your business.
The list of benefits of medical device product registration is as follows:
To address the growing need for accessible healthcare facilities in India, the government is increasingly relying on international medical device manufacturers to meet the rising demand. To ensure quality and regulatory compliance, India has implemented a medical device registration scheme. This framework plays a crucial role in maintaining uniformity, safety, and quality in medical devices available in the Indian market.
After obtaining Medical Equipment Registration, manufacturers and distributors must strictly adhere to the provisions of the Drugs and Cosmetics Act. The concerned authority will conduct on-site evaluations to assess the quality and safety of medical devices and equipment. Manufacturers are responsible for assisting the audit team by identifying potential concerns at an early stage. This proactive approach helps prevent future violations and penalties, ensuring compliance and prioritizing patient safety.
Manufacturers of medical devices in India face constant pressure to comply with regulatory standards, which can create challenges during business operations. However, the implementation of medical device registration helps reduce this complexity by providing structured guidelines that manufacturers must follow before entering the Indian market.
With the rising demand for medical devices in India, the government has legally permitted foreign companies and manufacturers to enter the Indian market. However, they must comply with CDSCO guidelines and adhere to all regulatory requirements while maintaining a high profit margin.
Medical Device product Registration enhances brand identity by increasing credibility in the market. Compliance with a standard regulatory framework ensures safety and efficacy, reinforcing trust among healthcare providers and patients.
The list of requirements for medical device registration in India is given below:
The given below table is the list of CDSCO forms for new medical device registration in India:
| Applicant | Class/Risk | Type of License | Forms |
|---|---|---|---|
| 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 |
The list of CDSCO forms for existing medical device registration are as given below:
| Applicant | Risk/Class | Type of License | Forms |
|---|---|---|---|
| Importer | A, B, C, D | Importer License | Application:MD-14 Permission: MD-15 |
| Manufacturer | A, B | Manufacturing License | Application:MD-3 Permission: MD-5 |
| 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 |
Given below is the list of entities or people who can apply for CDSCO medical device registration in India:
The list of documents required for medical device registration online in India is as given below:
The step-by-step process of medical device registration online is as follows:
Firstly, the applicant manufacturer must determine the correct classification of the medical device they wish to register. Only after identifying the appropriate classification, they can proceed with the application process.
The application must include all necessary details, such as information about the medical device, the manufacturing process, its composition, and formulation. Additionally, if available, relevant clinical trial data should also be provided.
Once the application is prepared, the applicant must submit it along with the mandatory documents on the CDSCO online portal and pay the prescribed fees. After receiving the application, CDSCO will review it. If any additional information or clarification is required, they may request the applicant to provide the same.
At this stage, CDSCO officials will review the application to determine whether the medical device is safe and effective for use. The evaluation process includes examining all relevant data, conducting site inspections, and consulting with experts in the respective field.
This is the final stage, where the CDSCO, based on the evaluation result, may either approve or reject the medical device product registration in India. On approval, the applicant or manufacturer can legally enter into the Indian market.
The list of post-compliances after obtaining medical product registration is given below:
The validity of a medical device product registration under CDSCO regulations is five years from the date of issuance of the registration certificate, subject to timely renewal before expiration. The licensee or manufacturer must renew the medical product registration every five years by submitting the necessary documents along with the prescribed fees to the concerned authority.
The table given below is the application fees for medical device registration in India as per the classification of devices as prescribed by the CDSCO:
| Medical device class | Fees for manufacturing site (per legal site) | Fees for Medical device family (per device family) |
|---|---|---|
| Class A Self-Notified | US $0.00 | US $0.00 |
| Class A Notified | US $1000.00 | US $50.00 |
| Class B | US $2000.00 | US $1000.00 |
| Class C | US $3000.00 | US $1500.00 |
| Class D | US $3000.00 | US $1500.00 |
You may choose Corpfilings for medical device registration online for the following reasons:
Yes, you must register a medical device in India before importing it for legal sale in the Indian market. As of October 1, 2023, all Class A (measuring or sterile), Class B, Class C, and Class D medical devices require an MD-14/MD-15 import license from CDSCO before being imported into India.
Domestic Manufacturers, Importers & Foreign Manufacturers, Indian Subsidiaries & Authorized Agents can submit a form for medical device registration in India.
The classification of medical devices is as follows:
The validity of medical device registration in India is for five years.
The Central Drugs Standard Control Organization (CDSCO) is India's key regulatory authority responsible for the approval, registration, and supervision of pharmaceuticals, medical devices, and other health-related products. Any product that falls under CDSCO regulations must obtain registration to enter and be sold in the Indian market.
Voluntary registration for medical devices in India is a temporary process for all non-notified Class C and Class D products, as per CDSCO notifications. This is an online registration process, and no fees are required for voluntary registration.
The medical devices in India are approved by the Drug Controller of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.
The list of documents required for medical device registration in India are as follows:
The mandatory compliances after obtaining medical device registration in India are post-market surveillance, adverse event reporting, labelling adherence, manufacturing conformity and QMS maintenance.
The medical device registration can be cancelled on non-compliance, safety issues, or insufficient surveillance.
Get in touch with our experts and initiate the process of registration and certification without any hassle.
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