India’s Central Drugs Standard Control Organization (CDSCO) issued answers to frequently asked questions on its new medical device rules and said licenses granted after Jan. 1, 2018 will remain valid indefinitely.
For applications submitted before Jan. 1 that are still being processed, devicemakers will need to resubmit the application and pay any additional fees, the regulatory authority said.
All new devices must comply with Jan. 1 date, but there is a grace period of 18 months from the date the rules were published to allow manufacturers of devices already on the market time to comply.
The country’s new Medical Devices Rules 2017, published on Oct. 27, 2017, marked the first time that India regulated medical devices separately from drug products.
New classifications are also in effect. The regulations classify devices into four risk-based categories — Class A to Class D — with Class D devices carrying the highest risk. The classification is in line with the risk-classification system used in most developed countries. For those devices that have a different classification in Global Task Force Harmonization countries, the higher classification will be used in India, CDSCO said.
The regulator clarified that Class C and Class D devices are granted a license after safety and efficacy are established via clinical trials. Licenses for lower-risk Class A and Class B devices may be granted after safety and performance is established via published performance data or clinical data from the country of origin.
For de novo devices that do not have predicate devices, clinical trials conducted in the United Kingdom, Australia, Canada, Japan, or the United States, may satisfy clinical requirements provided the device has been on the market for at least two years.
Applicants will need to obtain an investigational device exemption for each new medical device. For devices that are manufactured at multiple sites, additional fees are required for the additional sites. Postmarketing surveillance is the responsibility of the license holder sor authorized agent.
Manufacturers of devices and in vitro diagnostics will not need to apply for a separate import license for raw materials or components that are intended to be used in manufacturing the finished products, CDSCO said.
The regulations require devices sold in India to have a unique device identifier on the labeling beginning in Jan. 1, 2022.
Read the Q&A document here: www.fdanews.com/02-27-18-IndiaQA.pdf.