What is Loan License for a Medical Device?

A loan license is issued by the State Licensing Authority (SLA)/Central Licensing Authority (CLA) for manufacturing medical devices; it is an agreement between two manufacturers who grant the right to use their facilities and infrastructure for manufacturing the device. A company that wants to manufacture and market its medical device in India but does not have the necessary manufacturing capabilities for production should meet the Regulatory standards laid out by the Central Drugs Standard Control Organization (CDSCO).

China is a major player in the medical device industry, and with its diverse population and expanding healthcare market, companies need to understand the necessary clinical trial requirements for medical device products in this region. The Chinese government has implemented a variety of regulations to ensure the safety and efficacy of medical devices being placed on the market.

The National Health Surveillance Agency of Brazil (ANVISA) published a resolution RDC no. 657 on March 30, 2022, regulating Software as a Medical Device (SaMD). The resolution has been effective since July 1, 2022.

What is an eCopy?

An eCopy is an electronic version of your medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or flash drive. An eCopy is accompanied by a paper copy of the signed cover letter. It is to be noted that an eCopy is not the same as a Food and Drug Administration (FDA) electronic submission [PKJ1]. Following are submissions that require an eCopy:

The 510(k)-clearance program, also known as Pre-Market Notification (PMN), is US FDA’s device review pathway to ensure safe and effective entry of medical devices into the US territory. US FDA requires manufacturers of the majority of Class II devices and a few Class I and III devices to obtain 510(k)-clearance.