medical apparatus and instruments
The designated tests we provide for the designated products have been continuously changed and evolved by China National Accreditation Service (CNAs), German Accreditation Service (dakks), Hong Kong Accreditation Service (HKAS) and Japan's Ministry of health, labor and welfare, in order to better protect public health and safety. However, it may affect the customer's registration process with local or overseas regulators.
In CTC Chinese testing, we have a professional team to keep abreast of the latest regulatory requirements in key markets, to ensure that products meet regulatory requirements, and to support medical equipment manufacturers to quickly enter the market.
Main market
·Australia (DOH)
·Brazil (MOH)
·Canada (HC)
·China (nmpa)
·Europe (CE notified body MDD / MDR)
·India (MOH)
·Japan (MHLW)
·Korea (MFDs)
·Malaysia (MOH)
·Singapore (HSA)
·Taiwan (TFDA)
·Us (FDA)
Our medical device product classification and regulatory support services include:
·ISO 13485 certification document preparation (gap analysis)
·Purchase medical level components
·Compile technical documents and Archives
·Test products according to applicable industry standards
·Set up relevant testing instruments for product performance test
·Biological testing in accordance with GLP
·Submission of documents to regulators
·Act as local representative
·License holding and risk management
·On site support of supervision and inspection
·Provide GMS / QSR support in accordance with cfr820, ISO13485, MDR of Canada, GMP of South Korea, GMP of Brazil and 169 decrees of Japan
Electrical test
ISO 17025
CB plan
·NRTL program
Biocompatibility test (ISO 10993)
·Hemolysis test (ISO 10993-4)
·In vitro cytotoxicity test (ISO 10993-5)
·Implant test (ISO 10993-6)
·Detection of ethylene oxide sterilization residue (ISO 10993-7)
·Irritation test (ISO 10993-10)
·Skin allergy test (ISO 10993-10)
·Acute toxicity test (ISO 10993-11)
For more information about testing medical products, please contact us here.
Test service