CMDCAS Registration and Certification Consulting - 10236
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From January 1st, 2003, a new medical device regulation, Canada medical device law is put into practice. All medical devices sold in Canada, no matter local or imported, should get the permission of Canada medical device competent department in Health Canada.
Different from American FDA government, CMDCAS (Canadian Medical Devices Conformity Assessment System) registration law contains product registration and GMP certification, as well as the third party Notified Body CE certification in Europe and quality system certification of Canada government registration combine with the third party. The third party is referred to as the body which is recognized by CMDCAS. CMDCAS can be divided into 4 classes according to their risk: class one with the lowest risk, class four with the highest.
CMDCAS certification point:
In the certification, aside from obeying quality management system of ISO 13485/8:1996 or ISO 13485:2003 standard, on-site evidence must meet CMDR requirements.
Requirements of CMDCAS certification:
Devices manufacturers’ evaluation and risk analysis of relevant documents (ISO 13485/ISO 13488-4.4.1 and part ten of CMDR)
Manufacturer distribution and track process and record (ISO 13485/ISO 13488-4.8 and CMDR 52～56)
Suitable and effective process control and record (ISO 13485/ISO 13488-4.9 and CMDR 32)
Suitable sterilization and confirmation process (ISO 13485/ISO 13488-4.9 and CMDR No.17)
Process of dealing with complaints from producers (ISO 13485/ISO 13488-4.14 and CMDR No.57 and NO.58)
Noticing and recalling process of producer’s Mandatory question(ISO 13485/ISO13488-4.14 and CMDR 59～65)
Carrying storing, packing, protecting and paying process (ISO 13485/ISO13488-4.16 and CMDR 14 and 15)
Quality recording (ISO 13485/ISO 13488-4.14 and CMDR 32, 55)
Implantable medical device producer (The identification of the implant can be read in CMDR model 2) should have additional records which meet standards (CMDR No.66).
Osmunda Medical Device Consulting CO.LTD
Address: 7th Floor,JinGui business center,CongYun road No.982,Baiyun, Guangzhou, Guangdong, China,
Tel: 0086-020-62321333
Osmunda Medical Device Consulting Organization (Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen and Jinan) is the largest and most professional consulting company in the field of medical device in China. All Osmunda Consultant team members are from sizeable medical devices enterprises, well-known notified bodies and testing organizations. We are well versed in global various medical device quality system certification and product registration, such as SFDA registration, QSR 820 system, FDA registration, ISO 13485 system, CE certification etc. Our service includes clean room design, clinical trail, third party audit, training of regulations and standards, etc.
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