India strengthens its regulatory presence in Andhra Pradesh: what it means for manufacturers
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
India has announced the designation of the first regulatory body in the state of Andhra Pradesh authorised to inspect manufacturing facilities for Class A and Class B medical devices. This move brings clear advantages to manufacturers seeking faster, more accessible, and cost-effective CDSCO registration.
What’s new in Andhra Pradesh?
According to an official release, India has designated the first regulatory body in Andhra Pradesh authorised to conduct inspections for medical device manufacturing sites, specifically for Class A and Class B devices, under the Medical Devices Rules (MDR) 2017.
This step represents a major development in the decentralisation and expansion of India’s regulatory infrastructure.
Why this is relevant to medical device manufacturers
This development introduces concrete advantages for both Indian and international manufacturers, including:
- Faster access to inspections
- Reduced need to arrange audits in other regions
- Lower overall costs and administrative burden
In particular, micro, small, and medium-sized enterprises (MSMEs) can benefit from simplified regulatory workflows and shorter timelines, enabling faster product launches.
The growing opportunity of the Indian market
India continues to position itself as one of the most attractive MedTech markets in the world.
Thanks to a large population, growing healthcare demand, and continuous regulatory reforms, the country offers significant potential for companies aiming to expand internationally.
Strengthening local regulatory capacity, such as this recent designation, shows a clear commitment to building a robust, transparent, and efficient compliance system, aligned with global expectations.
Conclusion
India’s decision to enhance its regulatory infrastructure in Andhra Pradesh brings new opportunities for medical device manufacturers aiming to enter or expand within the Indian market.
If you’re planning to register your device with CDSCO, recent developments make the process more accessible than ever.
At CMC Medical Devices, we can support you in managing every step, from classification and documentation to the coordination of inspections and regulatory submission.
Contact us to explore how we can help you bring your device to the Indian market, fully compliant and without delays.
