In recent years, the Indian medical device industry has grown rapidly. From basic thermometers to high-end diagnostic machines, the demand for safe, effective, and high-quality medical devices has increased. To ensure this, the Central Drugs Standard Control Organisation (CDSCO) has taken major steps to improve how medical devices are regulated in the country.
In this blog, we will explain how CDSCO is streamlining medical device regulation in India, how the registration process works, and what manufacturers, importers, and businesses need to know to stay compliant.
What is CDSCO?
The Central Drugs Standard Control Organisation (CDSCO) is India’s national regulatory body for pharmaceuticals, cosmetics, and medical devices. It works under the Ministry of Health and Family Welfare and ensures that all products entering the Indian market are safe, effective, and meet quality standards.
Earlier, medical devices were not strictly regulated in India, except for a few like stents and syringes. But with the growing importance of healthcare, CDSCO expanded its role and now regulates most medical devices through a structured licensing process.
How CDSCO is Streamlining Medical Device Regulation
1. Classification of Medical Devices
To bring more clarity and control, CDSCO has classified medical devices into four risk-based categories:
Class A – Low Risk (e.g., thermometers)
Class B – Low to Moderate Risk (e.g., blood pressure monitors)
Class C – Moderate to High Risk (e.g., ventilators)
Class D – High Risk (e.g., implantable pacemakers)
This classification helps manufacturers know which level of regulation and licensing they fall under.
2. Simplified CDSCO Registration in India
Earlier, only a limited list of devices required CDSCO approval. Now, CDSCO has made CDSCO registration in India mandatory for a wide range of medical devices, especially after the 2020 Medical Device Rules.
The online Sugam portal allows businesses to apply for:
Medical device registration in India
Import licenses
Manufacturing licenses
This digital system has made the process faster, more transparent, and easier for companies to track their applications.
3. Improved Approval Timelines
Earlier, approval times for medical devices were long and unclear. CDSCO has now reduced approval timelines by implementing a robust review system and using experienced reviewers to assess applications based on risk category.
For Class A and B devices, State Licensing Authorities (SLAs) grant licenses, making the process quicker. Class C and D devices go through the CDSCO headquarters for more careful examination.
4. Focus on Quality and Compliance
CDSCO has made it mandatory for manufacturers and importers to follow quality management systems (QMS) like ISO 13485. This ensures that devices are manufactured and handled in a quality-controlled environment.
Also, post-market surveillance rules have been improved. This means companies must report device failures and adverse effects even after the product is launched.
5. Inclusion of Cosmetic and Drug Licensing
CDSCO not only looks after medical devices but also plays a key role in:
Cosmetic License Registration – Ensuring that cosmetic products are free from harmful ingredients and meet labelling and safety standards.
Drug License Registration – Granting manufacturing and sales licenses for pharmaceutical products and ensuring their safety and effectiveness.
This integration of drug, device, and cosmetic regulations helps create a unified system where businesses can apply for multiple licenses under one portal with standard rules.
Benefits for Businesses and Consumers
CDSCO's improved systems are not just about regulation—they help businesses and protect consumers too.
For Businesses:
Clarity in guidelines
Faster approvals
Digital tracking of applications
Single-window portal (Sugam)
Reduced paperwork
Boost to Make in India and imports
For Consumers:
Safer and better-quality medical devices
Reduced risk of faulty or harmful products
Transparency about approved products
Role of Corpbiz in CDSCO Registration
Getting CDSCO registration in India or medical device registration in India involves many documents, forms, and compliance checks. Many businesses find this process complex.
That’s where Corpbiz can help.
At Corpbiz, we have a team of legal and regulatory experts who specialize in:
Medical Device Licensing
Import and Manufacturing Licenses
Cosmetic License Registration
Drug License Registration
We assist in end-to-end services including document preparation, portal registration, and representation before CDSCO.
FAQs: CDSCO Medical Device Regulation
1. Is CDSCO registration mandatory for all medical devices in India?
Yes. As per the latest regulations, most medical devices now require mandatory registration with CDSCO, based on their risk classification.
2. What is the Sugam Portal?
The Sugam portal is an online platform launched by CDSCO for submission, tracking, and processing of licenses for drugs, devices, and cosmetics.
3. What is the difference between Class A and Class D devices?
Class A devices are low-risk (e.g., surgical dressings), while Class D are high-risk (e.g., heart valves). The higher the class, the stricter the compliance and approval process.
4. Can foreign manufacturers apply for CDSCO registration?
Yes. Foreign companies can apply for import licenses, but they need to appoint an Authorized Indian Agent who will represent them before CDSCO.
5. How long does it take to get CDSCO registration?
Approval times vary. For Class A and B devices, it can take a few weeks. For Class C and D, it may take several months depending on the complexity and completeness of the documents.
Final Words
CDSCO is playing a major role in making India a safer and more reliable healthcare market. By regulating medical devices through clear rules, quick approvals, and a digital system, it is helping both businesses and the public. If you're planning to enter the Indian market with a medical device, CDSCO registration is not just a legal requirement—it’s a mark of quality and trust.
For a smooth, expert-guided registration process, reach out to Corpbiz, your reliable compliance partner.
Author: Atul Shukla
Regulatory Expert at Corpbiz
Atul Shukla is a compliance and legal expert specializing in CDSCO registration, Drug Licensing, and regulatory approvals for healthcare businesses in India. With years of experience and successful projects, he shares his knowledge to help startups and businesses achieve faster licensing.
