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CDSCO Medical Device Registration- An Overview
If you are engaged in the medical devices business in India, obtaining CDSCO medical device registration is mandatory. For expert guidance on the registration process, connect with the CDSCO Medical Device registration consultants at Fastzeal.
The Central Drugs Standard Control Organization (CDSCO) is India’s regulatory authority responsible for the approval, registration, and oversight of pharmaceuticals, medical devices, and other health-related products.
India's healthcare industry, valued at $200 billion in 2023, is projected to grow to $370 billion by 2025. With over 900 pharmaceutical manufacturers, India is the 4th largest producer of pharmaceuticals globally. Under the supervision of the Drug Controller General of India, the CDSCO regulates this dynamic industry.
Earlier, only 15 categories of medical devices were regulated, leaving much of the market unregulated and dominated by global med-tech companies. However, the introduction of uniform standards has elevated Indian medical equipment to meet global quality benchmarks.
Talk to our CDSCO medical device license consultants for effortless registration.
CDSCO Medical Device Manufacturing License
In India, any medical device manufacturer must obtain a CDSCO Medical Device Manufacturing license. As such, medical devices that are cover under class A and B, the manufacturing licenses will be issued from the State Licensing Authority.
On the other hand, medical devices under category C and D the manufacturing licenses shall be issued from the Central Licensing Authority.
Benefits of CDSCO Medical Device Registration in India
Manufacturers and importers of medical devices looking to enter the Indian market are required to obtain CDSCO medical device registration. Below are the key benefits of securing CDSCO registration:
Who can Apply for CDSCO Medical Device Registration in India?
The given below are the entities or individuals who can apply for CDSCO medical device registration in India:
Requirements for CDSCO Medical Device Registration in India
The requirements for CDSCO medical device registration in India are as follows:
Documents Required for Medical Device Registration
The list of documents required for medical device registration is as follows:
Classification of Medical Devices under CDSCO Regulations
The Central Drugs Standard Control Organization (CDSCO) in India has classified medical devices into four classifications as given below:
Class A Medical Devices: Class A medical devices are low-risk devices, such as stethoscopes, bandages, and basic medical instruments. These devices have minimal potential to harm patients or users.
Class B Medical Devices: Class B medical devices are low to moderate-risk devices, including blood pressure monitors, syringes, and needles. While malfunctions could cause harm, the risk is not life-threatening.
Class C Medical Devices: Class C medical devices fall under the moderate to high-risk category, such as artificial heart valves, orthopedic implants, and catheters. Malfunctions in these devices could result in serious harm or injury to patients.
Class D Medical Devices: Class D devices are high-risk medical devices, including pacemakers, heart-lung machines, and ventilators. These devices are critical for patient health and survival, and malfunctions could lead to severe harm or even death.
CDSCO Forms for Registration of Existing Medical Devices
The list of CDSCO forms for registration of existing medical devices is as follows:
Application MD-14 Permission:MD-15: This is for importers for a medical device category A, B, C, D for applying importer license
Application MD-3 permission:MD-5: Manufacturers for medical device categories A and B must apply under this CDSCO form to obtain a manufacturing license in India.
Application MD-4 Permission:MD-6: This form is for manufacturers who want a CDSCO loan license in India.
Application: MD-7 Permission: MD-9: This form is for manufacturing licenses for the medical device category under C and D.
Application: MD-8 Permission: MD-10: This form is for a manufacturer who wants a CDSCO loan license in India.
CDSCO Forms for Registration of New Medical Devices
Application MD-22 Permission MD-23: This application is for importers for medical device categories A, B, C, and D for clinical investigation permission.
Application MD-26 Permission MD-27: This application is for importers of medical device categories A,B,C,D for an import license.
Application MD-16 Permission MD-17: This application is applicable to categories A, B, C, D for a test license.
Renewal of CDSCO Medical Device Manufacturing License
As per the Central Drugs Standard Control Organization (CDSCO), the medical device manufacturing license must be renewed at least nine months before the expiration of the registration certificate.
While no additional documents are required for the renewal of CDSCO medical device manufacturing license, the certificate holder shall submit a copy of the Plant Master File (PMP) and Device Master File (DMF) to confirm that no changes have been made.
Post Compliance Medical Device Registration Online
Some of the important post compliance after obtaining medical device registration online are as follows:
Fees for CDSCO Medical Device Registration
The government fees for CDSCO medical device registration are specified into several categories depending upon the type of license and classification of medical devices.
The CDSCO Medical Device Manufacturing License Fees, for device class A and Class B, the governmental fee is INR 5000/-(one site) and INR 1000/- (for each distinct medical device). For class C and D medical devices, the governmental fee is INR 50000 (one site), and INR 1000 (for each distinct medical device).
Timeframe for Obtaining CDSCO Medical Device Registration
The timeframe for obtaining CDSCO medical device registration takes around six to nine months. Meanwhile, the validity period of CDSCO medical device registration is three years from the date of issue of registration unless it is revoked or suspended by the concerned authority with a relevant cause.
Offerings by our CDSCO Medical Device License Consultants
Have a look at the key offerings by our CDSCO medical device license consultants-
Why Pick Fastzeal for CDSCO Registration for Medical Devices?
Fastzeal, a leading CDSCO Medical Device License Consultant, offers comprehensive services to streamline the CDSCO medical device registration process, ensuring compliance with Indian regulatory standards.
Given below are the reasons why entrepreneurs in the medical device industry partner with us for CDSCO registration for medical devices-
Frequently Asked Questions:
If you are engaged in the medical devices business in India, securing CDSCO registration for medical devices is mandatory. For expert guidance on the registration process, connect with the CDSCO Medical Device registration consultants. The Central Drugs Standard Control Organization (CDSCO) is India’s regulatory authority responsible for the approval, registration, and oversight of pharmaceuticals, medical devices, and other health-related products.
To register a medical device in India one must file an application before the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services in the Ministry of Health and Family Welfare.
Any organization that is engaged in importing or manufacturing drugs and cosmetics, conducts R&D activities in connection to drugs, or imports drugs for the purpose of testing needs to obtain a CDSCO medical device registration.
You can get your CDSCO medical manufacturing license by filing an application for medical device registration online on the official websites, followed by submitting the necessary documents. Lastly, the said application shall be reviewed and evaluated by CDSCO.
In India, the CDSCO regulates and approves medical devices to enter the Indian Medical Device Market.
Class C medical devices refer to a high individual or moderate risk to public health.
A license for manufacturing facilities to sell, export, and import medical devices has to be obtained from the Central Drugs Standard Control Organisation in India.
Some of the examples of medical devices in India are-
Spinal needles
Dental Implants
Catheters
Cardiac Stents, etc.
A Clinical assessment or investigation in India means testing to check the safety and performance of medical devices that are to be sold or distributed in the Indian Market.
Is it necessary to register my medical device in India?
Yes, it is necessary to register for medical devices in India; as per the notification dated October 1, 2023, all class A, B, C, and D medical devices require an MD-14/MD-15 import license with CDSCO before importing into India.
The Central Drugs Standard Control Organization (CDSCO) serves as the central regulatory authority, responsible for carrying out functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO operates through six zonal offices, four sub-zonal offices, 13 port offices, and seven laboratories across the country.
The Central Drugs Standard Control Organization (CDSCO) serves as the central regulatory authority, responsible for carrying out functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO operates through six zonal offices, four sub-zonal offices, 13 port offices, and seven laboratories across the country.
Key responsibilities of CDSCO include regulating drug imports, approving new drugs, overseeing clinical trials, conducting meetings of the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), and granting certain licenses in the coordination of the activities of the State Drug Control Organizations by facilitating expert advice with a view to bringing uniformity in the enforcement of the Drugs and Cosmetics Act.
The demand for medical devices in India is a $5 Billion market, and the demand in India must increase in the future as well.
The medical devices imported into India are- Ultrasonic Scans, PCR (Polymerase Chain Reaction) Test Tech, Medical Imaging, Cancer Diagnostics, etc.
Since January 2018, the CDSCO has been the force control on medical devices in India.
Some of the examples of medical devices in India are-
- Spinal needles
- dental Implants
- Catheters
- Cardiac Stents, etc.
