CDSCO Registration for Medical Devices/IVDs/Cosmetics

Corpbiz guarantees to provide you with 100% assistance in CDSCO Registration of Medical Devices, IVDs, or Cosmetics in India by maintaining transparency. Also, we have more than 250+ CDSCO experts all over India who have done many CDSCO Registrations in all over India.

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About Corpbiz

5000+ Projects

5000+ Projects

We have done 5000+ projects all over India.

20,000+ Happy Clients

20,000+ Happy Clients

We have helped 20,000+ clients to get their product certification in minimal time.

250+ Locations

250+ Locations

We are located in 250+ different locations in India

80% Market Share

80% Market Share

In this industry, we have covered 80% of the Market Share, which is higher than any other competitors.

Services We Offered

(We make technical compliance certifications effortless and convenient.)

Which Body Provides Registration for Medical Devices/IVDs/Cosmetics in India?

CDSCO or Central Drugs Standard Control Organisation, is a Central Drug Authority responsible for discharging functions which are assigned to the Central Government under Central Drugs & Cosmetic Act.

India is a big importer of Medical Devices, if compared to other nations, it offers a steady market opportunity for Global Medical Device Manufacturers.

Considering the quality assurance of the product quality of medical devices for substantial growth of the IMD (Indian Medical Device) Industry is expected to operate as per the upcoming regulatory guidelines that are IMDR 2017 issued by CDSCO.

Registration for Medical Devices
Medical Devices India

The Market for Medical Devices in India

With the increasing demand for medical facilities in India, the market for medical devices is growing rapidly. The medical devices Industry in India is one of the largest in Asia and is amongst the top 20 players in the world.

This industry is highly capital intensive, and there is immense scope as far as a skilled workforce and Research & Development are concerned. The Government has devised a few schemes to promote the market of medical devices in India.

The market of medical devices in India is expected to grow at a Compound Annual growth rate (GAGR) of 37% to reach US$ 50 billion in 2025, from US$ 10.36 billion in the Year 2020.

The significant nations with whom India is engaged in importing Medical Devices are the US, Singapore, China, Brazil & many more.

Different Classes of Medical Devices in India

According to the MDR, 2017, Risk-Based Classification for Medical Devices & IVDs was done. This classification was as per the rules established by IMDRF.

Classes1
Classes2
Classes3
Classes4

Classification of Medical Devices in India

In India, Medical Devices under CDSCO have been classified into 2 different categories; you can check the same below:

Notified Medical Devices
Notified Medical Devices

1. According to Provisions of Rule 4 of the MDR, 2017, Notified Medical Devices are those devices whose Certification is compulsory.

2. Notified Medical Devices comprises a total of 37 products which are mandatory and need to be CDSCO certified.

Non-Notified Medical Devices

1. According to the new Amendment issued by CDSCO, Devices such as apparatus & implants, irrespective of their usage for a different purpose, will fall under Non-Notified Medical Devices.

2. Non-Notified Medical Devices comprises a total of 313 products which are mandatory and need to be CDSCO certified.

Non-Notified Medical Devices

Authorities for Providing License & Approval for Medical Devices

State Licensing Authority

SLA or State Licensing Authority

SLA has been entrusted with providing Manufacturing Loan & Wholesale License to Medical Devices under Class A & Class B.

Corpbiz SLA

CLA 0r Central Licensing Authority

CLA is entrusted to provide Licenses to all the imported medical devices in India, including Loan, Manufacturing & Wholesale License to Medical Devices under Class C & Class D.

Our Role in CDSCO Registration

Selection of Product Class

Selection of Product Class

Our CDSCO experts will check under which class your product falls, including whether a product complies with the CDSCO standards or not.

Analyse the Product Requirements

Analyse the Product Requirements

Then, our experts will analyse the product requirements to give clear guidelines.

Provide Finest Solution

Provide Finest Solution

In case of any concern regarding CDSCO Registration, we assure to provide the finest solution regarding CDSCO Registration.

Regular Follow-ups with Concerned Authorities

Regular Follow-ups with Concerned Authorities

Our CDSCO Experts will coordinate with the concerned Authorities for regular follow-ups.

Conduct a Virtual Pre-Audit

Conduct a Virtual Pre-Audit

Our CDSCO consultants are equipped with the vital resources to conduct a virtual pre-audit to confirm whether your manufacturing unit is complying with CDSCO requirements or not.

Our Achievements

8+ Years of Experience

8+ Years of Experience

250+ CDSCO Experts

250+ CDSCO Experts

50000+ Clients

50,000+ Clients

5000+ CDSCO Registrations

5000+ CDSCO Registrations Done

50,000 customers and counting!

Testimonials

Some testimonials from our customers

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