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.
(We make technical compliance certifications effortless and convenient.)
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.
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.
According to the MDR, 2017, Risk-Based Classification for Medical Devices & IVDs was done. This classification was as per the rules established by IMDRF.
In India, Medical Devices under CDSCO have been classified into 2 different categories; you can check the same below:
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.
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.
SLA has been entrusted with providing Manufacturing Loan & Wholesale License to Medical Devices under Class A & Class B.
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 CDSCO experts will check under which class your product falls, including whether a product complies with the CDSCO standards or not.
Then, our experts will analyse the product requirements to give clear guidelines.
In case of any concern regarding CDSCO Registration, we assure to provide the finest solution regarding CDSCO Registration.
Our CDSCO Experts will coordinate with the concerned Authorities for regular follow-ups.
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.
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