CDSCO Regulatory Compliance : It’s Not as Difficult as You Think

The medical device industry plays a crucial role in the country’s healthcare sector. Country’s medical device market influenced by multinationals. India is among top 20 countries in world for the medical devices market. Our government is putting efforts to strengthen the sector; innovation and new technology, proficient people in the area becoming the pillar of the sector. In India Medical devices are regulated as per CDSCO. CDSCO has an objective to ensure the safety efficacy and quality of Drugs and medical devices.  

CDSCO controls licensing, manufacturing, and distribution of medical devices in India. The medical device sector has been greatly impacted by Covid-19 pandemic. The growing use of gloves, masks, disposable syringes, sanitizers, diagnostic equipment etc. has benefited many firms.

Top players of the industry generate big revenues which may be fascinating and attract many new entrepreneurs, but manufacturing medical devices is not an easy task as they are the essential tools and have an impact on quality of life and public health. 

Manufacturers get stuck with regulatory compliance process due to lack of knowledge about, 

•  licensing procedures,  
• QMS implementations,  
• designing the plant layout as per prescribed guidelines etc. 

 They feel this as complex and tedious process, but let me tell you that CDSCO regulatory compliance is not as difficult as you think, if you consult with the right medical device consultant. Your experienced medical device consultant will help you in regulatory compliance, provide turnkey solutions for your project, guide you in clinical evaluation etc. Many manufacturers approach to use to understand the guidelines and process of CDSCO manufacturing license and we are happy to share those satisfactory results came out. 

In conversation with manufacturers, we have noticed that the majority of manufacturers and the people who guides them don’t understand the importance of post market surveillance, clinical Evalution, testing devices and getting license from the correct notified body. They are struggling with the complete compliance process. Medical care and device manufacturing is a sensitive matter and failure to obtain the necessary certificate and licensing may create unnecessary problems.so it is always advisable to abide with laws and regulations set by the respective authorities. 

Nation’s leading medical device regulatory service provider, Operon Strategist simplifies complex regulatory processes and helps you to get regulatory compliance easily. Despite all challenges and problems, we have reached new highs again, in less than 5 months we have helped 500+ medical device manufacturers in India and 100+ international clients for obtaining CDSCO mandatory registration as the time will reach out soon.  

The Indian medical device industry holds great potential for domestic as well as international players. Country’s Atmnirbhar Bharat mission and projects like Yamuna Expressway will have new sectors in coming two decades, which encouraging the new national as well as international manufacturers to invest in healthcare sector, and it show us that the Opportunities in India healthcare sector is limitless.  

We thank our clients for trusting us and making us leading consultant in the field of medical device regulatory services, unlike many manufacturers you can also encash this opportunity and can be a part of booming industry. We believe that our services and work methodology will help you to perform well in the market.

We are a leading medical device regulatory consultancy  trusted by medical device manufacturers for more than a decade. we provide consultation for CDSCO registration and manufacturing license to national as well as international manufacturers also helps in designing the units, obtaining the CDSCO license for the business, post market surveillance and in many regulatory ways. Our network and experience of working with certified and notified bodies will give you hassle-free results. To avail our cost-effective regulatory compliance services contact us today.