How do you export medical devices?
Global Export Strategy for Diagnostic Devices, Therapeutic Devices, and Medical Supplies
Market Overview
The global medical device market is approximately $500 billion and is growing at over 5% annually due to aging populations and increasing healthcare demands. South Korea is competitive in diagnostic devices, dental equipment, and aesthetic medical devices.
Key Export Markets
The major markets include the United States (FDA 510(k)/PMA), EU (MDR/CE marking), Japan (PMDA), China (NMPA), and Brazil (ANVISA). Medical devices have a lengthy approval process, making prior preparation essential.
Mandatory Certification
CE marking (EU MDR), FDA approval/510(k) (USA), PMDA approval (Japan), NMPA registration (China), GMP/QMS (Quality Management System), ISO 13485 (Medical Device Quality Management) are required.
Buyer Types
There are hospitals/medical institutions, medical device distributors, government/public procurement, and clinic chains.
Major Exhibitions
Notable events include MEDICA (Germany, November), Arab Health (UAE, January), CMEF (China, April/October), FIME (USA, June), and KIMES (South Korea, March).
Buyer Type
Hospitals/Medical Institutions
General hospitals, specialty hospitals, clinics
Medical device distributor
Local medical device import/distribution company
Government/Public Procurement
National healthcare system, public hospital procurement
Mandatory Certification
Major Exhibitions
| common.tableHeaders.tradeShowName | common.tableHeaders.location | common.tableHeaders.period |
|---|---|---|
| MEDICA | Düsseldorf, Germany | November |
| Arab Health | Dubai, UAE | January |
| CMEF | China (Shanghai/Shenzhen) | April/October |
Frequently Asked Questions
Q. What is the difference between FDA 510(k) and PMA?
A. The 510(k) process demonstrates substantial equivalence to existing similar products, while PMA is a more stringent approval process that requires direct proof of safety and efficacy. It varies according to the risk classification.
Q. What are the differences between the EU MDR and the previous MDD?
A. MDR is a regulation that has been strengthened compared to MDD, with increased clinical data requirements, enhanced post-market surveillance, and the introduction of the UDI system. The certification period and costs have also increased.