OGAWA Malaysia
Malaysian wellness massage-chair and health-device manufacturer.
OGAWA Malaysia manufactures massage chairs, foot massagers, wellness devices, and home health appliances. Founded in 1996, the company supplies wellness retailers, shopping-mall stores, and regional distributors.
- Type
- Manufacturer
- Location
- Kuala Lumpur, Malaysia
- Founded
- 1996
- Website
- ogawa.com.my
- Categories
- Home Appliances, Medical & Healthcare Supplies
- Markets
- Malaysia, Singapore, Thailand, United Arab Emirates
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
- Consumer goods sold in the EU fall under the General Product Safety Regulation (GPSR, applies since 13 Dec 2024): a responsible person in the EU is mandatory. EUR-Lex: Regulation (EU) 2023/988 (GPSR)