Dec 15, 2020 | News, Regulatory
Under its Abbreviated 510k Program, the U.S. Food and Drug Administration (FDA) outlined guidelines for the Safety and Performance Based Pathway, a fast track for medical devices in well established categories to gain market...
Jan 22, 2020 | News, Regulatory
What is NRDL? NRDL is introduced in 2000 to support medical healthcare and providing patients with basic medical treatments. Between 2000 and 2017, the NRDL has been updated twice, but the reimbursement process is poor. The third update is in 2018, where 10 new drugs...