India’s medical device market regulator, the Central Drugs Standard Control Organisation (CDSCO), have released a new Frequently Asked Questions (FAQ) document to help clarify questions from the industry regarding the new Medical Device Rules.
Since implementation of the Indian Medical Device Rules in January 2018, Indian medical device registrants have brought up questions concerning issues such as registration renewals, marketing applications currently under review and changes to the CDSCO list of notified medical devices. The new FAQ document from CDSCO includes 55 questions and answers which aim to address compliance with the Indian Medical Device Rules.
The CDSCO has stated that license applicants who made a submission to CDSCO on or after 27th October 2017 should deposit license retention fees and the related documents according to the Medical Device Rules requirements. For companies whose applications were submitted before 1st January 2018, but have yet to receive final decisions from CDSCO, will need to pay an application fee and resubmit their applications via the new online registration portal SUGAM.
Questions have been raised as to whether compliance with international device standards from entities such as the International Organisation for Standardisation (ISO) and the International Electrotechnical Commission (IEC) would allow registrants to also meet Bureau of Indian Standards (BIS) requirements. According to the FAQ, devices must conform to standards explicitly identified by the BIS, however in cases where no appropriate standard has been identified, a manufacturer should ensure compliance to the relevant ISO, IEC or other international standard, or in some instances to the company’s own validated standard.
Additional Medical Device Rules questions which are addressed in the FAQ document include:
- India Authorised Agents are responsible for managing post-market surveillance activities.
- Medical Device Rules 2017 risk-based device classification schemes will be harmonised with other international classification systems.
- A firm may pay a single import license fee for a grouped submission so long as all devices in that group share similar technology, intended use and product specifications.
- A manufacturer that changes their India Authorised Agent must obtain a new license from CDSCO.
CDSCO advises active manufacturers in the Indian market to familiarise themselves with the new FAQ to determine how the Medical Device Rules 2017 will affect their compliance.
To read the new FAQ document from India’s CDSCO on the Medical Device Rules, please click here.