The Indian medical device industry is amongst the top 20 markets worldwide and considered as one of the fastest growing. Since approximately 80% of the Indian medical device needs are met through imports, it is essential to have a strong medical devices regulatory regime. The Indian regulatory agency, the CDSCO, make a conscious effort to improve their regulations to release safe and efficient medical devices into the market. The CDSCO under the MDR 2020, the recent amendment of Medical Device Rules (MDR) 2017, now requires all the devices imported and placed in Indian market to be mandatorily listed by October 2021 followed by their registration in upcoming years.
Medical device regulations in India gradually evolved over the period of time from medical devices being considered as drugs to having standalone regulations, defined under The Medical Device Rules, 2017. Currently, only 37 device categories called the notified devices are regulated and are required to follow the registration process in order to be able to sell in Indian market. In February 2020, the amendment, MDR 2020 require all the devices to be mandatory listed and all foreign manufacturers to appoint an Indian Authorized Agent (IAA).
As a device manufacturer, do you understand India’s current Regulatory dynamics, applicable regulations, and different device registration pathways? Have you a clear-cut idea on the following aspects?
- Overview of Indian Medical Device Industry
- Overview of Indian Medical Device Regulatory Landscape
- Brief background on device regulations
- Current regulatory dynamics and compliance timelines
- Recent notification released by CDSCO
- Regulatory requirements for Notified and Newly Regulated Devices
- Regulatory overview
- Overview on Notified devices
- Overview on Newly regulated devices
- Registration Pathways for Medical Devices and IVD registration in India
- Factor influencing registration process
- Device listing of newly Notified devices
- Manufacturing license for Notified devices
- Import license for Notified devices
- Test license for medical devices and IVDs
- Registration Listing of Newly regulated Medical Devices
- Classification of newly regulated medical devices
- Documentation requirements for registration listing
- Process for registration listing
- Role of Indian Authorized Agent in medical device compliance
To explore the vast Regulatory landscape of the Indian medical device industry, Freyr brings to you an exclusive webinar on “Indian Medical Device Regulatory Landscape- A Deep Dive,” scheduled on September 22, 2021. In this webinar, our in-house Regulatory expert, Sushma Yedunuri, Head - Indian medical device projects, will elaborate on the current scenarios, compliance timelines, and the CDSCO initiatives for medical devices in India. Register now for clear-cut insights.