4 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIA

US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.

DON’T PLAY ROULETTE WITH YOUR RUSSIAN TEST REPORTS

Considering the complexity of the importing test samples and the risk of test laboratories losing accreditation, it is important for manufacturers seeking medical or diagnostic device registration in Russia work with an experienced, local partner who can make an informed selection of test laboratories and take fast corrective action should the selected lab be affected.

MEDICAL DEVICES SHIPMENTS DURING THE COVID-19 PANDEMIC

COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.

Russia Streamlines Medical and IVD Device Regulations

On the May 31st Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor) published Decree No. 633 which includes provisions that significantly improve the registration process for medical and IVD devices. The changes go into full effect on June 13th, 2018.

Asia Actual Expands into Russia