Quality and Regulations

UMT has established a quality system that complies with IS013485, MDD93/42/EEC, FDA 21 CFR 820 and Chinese GMP requirements, and has received the accreditations for ISO 13485 and MDSAP.


At UMT we are continuously improving our systems to ensure compliance with leading international regulations. Our products have obtained CE certification and FDA clearance.


Our regulatory team can provide professional supports to customers concerning registration or other regulatory affairs

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