9.4 million+ COVID-19 cases in the world is putting a huge demand on syringes used for administering medication. Some of the top 10 syringe exporting countries like, China, Italy, the USA and the UK, are facing production and transportation restrictions due to the coronavirus pandemic. Local companies are stepping up to increase syringe production and tackle the current public health emergency.
The EU classifies syringes as Class IIa medical device under Medical Device Regulation (EU) 2017/745 (MDR). Manufacturers and suppliers go through a cumbersome process to receive CE certification – from product classification to product registration with notified bodies in Europe.
Epinephrine syringe, vacuum syringe and anti-stick glass syringe are some of the different types of syringes. The manufacturer/supplier of all syringe types must meet the 510(k) submission requirement, which must be submitted in the eCopy format and sent to CBER or CDHR’s Document Control Center. Before marketing syringes, manufacturers must undergo the 100-day FDA approval process.
CE Mark Compliance and FDA Compliance are a must for the production and supply of syringes.