The changing Regulatory scenario always having an impact on medical device manufacturers. Central Drug Standard Control Organization (CDSCO) is the regulatory authority of India under the Ministry of Health & Family Welfare. CDSCO regulates the manufacturing of medical devices of all classes. So that devices manufactured are safe to use, have good quality, have high efficiency, and fulfill their intended purpose.
For the past few months, CDSCO has been working to bring frequent updates on the manufacturing, sale, and distribution of medical devices in the Indian market. CDSCO has been updating the manufacturer’s change in regulations, changes in medical device form, documents required to be submitted along with forms, certificates needed by the devices, and how to manage pre- and post-market surveillance.
The main aim of CDSCO is to harmonize the Indian regulatory framework with the rest of the regulations around the world so that Indian manufacturers can also sell their devices overseas. Any manufacturer who fails to comply with the rules and regulations of CDSCO will not be allowed to sell their devices. Thus, they must understand that compliance is now the main target of CDSCO to bring the best quality of devices to the Indian market. CDSCO follows a few regulations, such as Medical Device Regulation (MDR), Drug and cosmetic act 1940 and rules 1945, Legal metrology act, etc. They regulate medical devices from planning till it reaches the market and even post-market complaints. CDSCO updates them from time to time.
Regulatory Scenario changes day by day, lets’ check how it effects on the manufacturer :
Changing regulatory scenario and MDR 2020 – The separate framework to regulate medical devices
Medical device regulation (MDR) came into effect in April 2020, when the regulatory authority of India redefined what a medical device is. The main aim of MDR 2017 was to give a separate regulatory framework to medical devices so that the Government of India can regulate medical devices with strict rules and regulations. After MDR 2017, except for 37 notified devices, all devices were required to register and comply with the regulations set by CDSCO. The manufacturers can now register their medical devices on the online portal. Different Medical Devices forms are available at the CDSCO site, along with many documents that need to be present at the time of registration. It includes the name and address of the manufacturer, details of the manufacturing site, and compliance with different applicable certificates. Along with manufacturers, importers too need to register their devices along with a free sale certificate from the country they manufacture. The main focus of MDR is to keep an eye on the quality, safety, and efficacy of medical devices since they will directly affect the population’s health.
- MDR 2017’s risk-based classification system to make sure better risk management
MDR classifies medical devices into four classes based on the risk they possess to consumers and other parameters such as intended use.
| Class | Risk level | Example |
| A | Low risk | Tongue depressor |
| B | Low moderate risk | Suction equipment |
| C | Moderate high risk | Bone fixation plane |
| D | High risk | Heart valve |
The main aim of the new classification was to bring more clarity to manufacturers so that they could classify the device and comply with the regulations as per the class. Not only the manufacturer but importers, too, need to follow different pathways to import medical devices of different classes. While manufacturing or importing, the material used in the medical device must comply with regulations. Our team helps manufacturers to classify their product to apply for the regulatory requirement
Changing Regulatory scenario brings positive change and Open doors for new opportunities:
The new medical device regulations opened new doors for many opportunities. Many players came to the market, and India saw a robust increase in the manufacture and import of medical devices. There is also an increase in the number of consultancies that help the manufacturer to comply with regulations. With the regulatory framework, it is somewhat easy to control the quality of medical devices being marketed in India only after they fully comply with the regulations laid out by CDSCO. Since the medical device players have to follow the regulations of CDSCO, it ensures a double check on the credibility of the medical device.
- ISO 13485 compliance to harmonize with the international market
CDSCO has made ISO 13485- Quality management system a pre-condition to register the medical device. Its main motive is that the Indian manufactured medical device can access different markets worldwide and are harmonized with the rest of the global regulatory frameworks. After ISO 13485 implementation, it helped the manufacturers increase their credibility as this certificate proves that manufacturers follow high-quality standards while manufacturing medical devices. The CDSCO has clarified that if any manufacturer fails to imply the certificate before May 2022, CDSCO will cancel their registrations.
CDSCO: Registration time is required for manufacturers of different classes.
CDSCO published guidance on September 21st, 2021, stating that all the manufacturers of class A and B medical had to register their devices before September 30th, 2022, as after that, there is no extension. And the manufacturers of class C and D medical devices have time till September 30th, 2023. After the deadline passes, CDSCO will stop all medical devices not complying with regulations from being sold.
CDSCO now takes the quality of medical devices being marketed seriously. So now, manufacturers are advised to adhere to regulations set by the CDSCO and make sure their device complies with the regulations to sell their devices without interruption. CDSCO targets Indian manufacturers to be able to sell their devices in the country, thus opening new opportunities for them. With the changing regulatory scenario, a separate framework to regulate medical devices was right to demand since these devices help diagnose, treat, cure, and prevent diseases. In most cases, doctors take decisions based on the results shown by these devices, thus directly impacting the lives of citizens. That’s why CDSCO, along with the Government of India, is making stricter rules to make sure devices comply with their regulations. As a CDSCO medical device consultant we always assist and provide guidance of updated rules and regulations to our clients , so that they can easily comply with the regulations.
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