Why CDSCO Approval Matters for Medical Consumables in Indian Healthcare

India is shining bright in the global MedTech landscape, with its medical consumables market share poised to conquer 10-12% of the world market within the next 25 years. This means that we are competing with the world titans in terms of safety, efficacy, quality, and reliability. This is where CDSCO approval matters and acts as a hallmark for medical consumables. 

What is CDSCO approval?

The Central Drugs Standard Control Organisation (CDSCO) is responsible for regulatory approvals to medical device manufacturers in India. This license is mandatory to ensure the safety and quality of the devices being manufactured. If a medical device is manufactured, imported or sold in the Indian market, it has to be approved by the CDSCO. The medical devices are classified into Class A, B, C and D based on risk level, and the certificate is issued after a series of clinical trials and approvals. 

Now, let’s understand why CDSCO approval matters for medical consumables in Indian healthcare.

Importance of CDSCO approval

• All-encompassing assessment of the product: CDSCO approval means that the entire lifecycle of the medical product, right from medical trials to market monitoring, is comparable to world standards when it comes to safety, efficacy, quality and reliability. 
• Marketing authorisation: CDSCO approval is an important prerequisite if you want to market a new or existing product in the Indian market. 
• Licensing and Regulation: The CDSCO is the ultimate regulatory authority when it comes to the standard of medical consumables manufactured or imported in the Indian market. 
• Safeguards public health: By ensuring that the medical consumables circulating in the Indian market are at par with the global standards, a CDSCO approval means that public health is safeguarded against unsafe or substandard products. 
• Resurrects customer confidence: If you are wondering why CDSCO approval matters for medical consumables in Indian healthcare, you must know that it acts as a hallmark for medical consumables. CDSCO approval guarantees quality and safety. 

How Surgikart can be your trusted CDSCO-approved partner?

We at Surgikart manufacture surgical disposables at par with global standards and strive to maintain safety, quality and compliance with regulatory standards while constantly chasing innovative technology. At our in-house sterilisation plant, clean room and quality control laboratory, we compete with our own selves to surpass international standards and deliver reliable products of unparalleled quality. With over 40 product categories, offering the best in market customisation, we at Surgikart are poised to be your trusted partner in this journey.