India: The MD 15 Exemption of Class A Non Measure / Non Sterile Devices

An announcement made by the Indian Ministry of Health and Family Welfare (MOHFW) on October 2022 stated the exemption of Class A non-measuring and non-sterile medical devices from import license (MD-15). The exemption also applied to a few chapters of the Medical Devices Rules (2017). Since Class A non-measuring and non-sterile have been an exception for licensing regime, the said medical devices also were excepted from the registration requirement in the Central Drugs Standard Control Organization system (CDSCO).

Some of the medical devices that are classified under Class A non-measure and non-sterile are scissors, scalpels, gloves, gauze and bandages. Manufacturers may refer to the Central Drugs Standard Control Organization portal for more list on the classification.

Further, the exemption also simplifies the registration for non-measuring and non-sterilizing devices. Manufacturers do not have to submit Device Master File (DMF) and Plant Master File (PMF). Less registration period and less cost involved so Class A non-measure and non-sterile medical devices can enter the market easier.

However, manufacturers are still required to manually upload information about the product into MOHFW’s system. The information needed in the system is the general name, brand name, model, materials, product use, dimensions and shelf life. Manufacturers or importers remain responsible for manufacturing, sales and distribution documentation, answering requests from the Licensing Authority about the records, labels, instructions and document verification.

Other than that, manufacturers or importers must provide clear documentation regarding the device classification, the safety and performance self-certificate, self-attested copy of the manufacturer issued by the National Regulatory Authority, self-certification from the importer that shows products comply with MDR 2017, signed documentation proving that all information provided is authentic and lastly registration number received during the online submission.

Since the system does not have data portability function between CDSCO and MOHFW, manufacturers still have to manually update the information for every device’s model. There is no requirement for accessories details to be submitted and all Class A non-measure and non-sterile medical devices are also eligible for Free Sales Certification (FSC) from any country. After all, these new rules only apply to Class A non-measure and non-sterile medical devices. For Class A measures and sterile medical devices, the requirement remains unchanged.

Source: Central Drugs Standard Control Organization system (CDSCO)

Contact us at info@arqon.com for more information.