CCC (China Compulsory Product Certification) - Registration bodies in North America?

P

piney

#1
We have been contracted to build equipment for a customer that will require China Compulsory Product Certification (CCC Certification). Part of the certification process requires having a audit by a CCC registration body, which includes covering all of their costs to come from China to Canada (likely +$20K).

Does anyone know of a CCC registration body located in North America?

Thanks in advance.
 
Elsmar Forum Sponsor

Miner

Forum Moderator
Staff member
Admin
#2
Re: CCC (China Compulsory Product Certification) - Registration bodies in North Ameri

We have been contracted to build equipment for a customer that will require China Compulsory Product Certification (CCC Certification). Part of the certification process requires having a audit by a CCC registration body, which includes covering all of their costs to come from China to Canada (likely +$20K).

Does anyone know of a CCC registration body located in North America?

Thanks in advance.
The UL-Asia website FAQs states that only 76 accredited Chinese labs can perform the testing, and that inspectors from the Chinese certification body conduct the factory inspection.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#3
Re: CCC (China Compulsory Product Certification) - Registration bodies in North Ameri

What Standard is this certification to? ISO Guide 65? ISO/IEC 17025 or 17020? ISO 9001?
 

Miner

Forum Moderator
Staff member
Admin
#4
Re: CCC (China Compulsory Product Certification) - Registration bodies in North Ameri

What Standard is this certification to? ISO Guide 65? ISO/IEC 17025 or 17020? ISO 9001?
This is product specific testing, like UL or CSA certification.
 

Ajit Basrur

Staff member
Admin
#6
Re: CCC (China Compulsory Product Certification) - Registration bodies in North Ameri

You can refer this website also for more info -

http ://ec. europa .eu /enterprise/ enterprise_policy/gov_relations/china_regul_coop_dialogue/sem_doc/china_Liu.pdf - DEAD LINK DEATIVATED.
 
Last edited by a moderator:

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#7
Re: CCC (China Compulsory Product Certification) - Registration bodies in North Ameri

This is product specific testing, like UL or CSA certification.
I reviewed the link supplied by another poster here.....it does appear to be more like product certification, which suggests accreditation under ISO Guide 65.....two of the organizations listed in the linked document are certainly Guide 65 accredited.....
 
Thread starter Similar threads Forum Replies Date
R UL & CCC (China Compulsory Certification Mark) Certification Requirements Various Other Specifications, Standards, and related Requirements 1
O Mystery of China SFDA (State Food and Drug Administration) and CCC ISO 13485:2016 - Medical Device Quality Management Systems 26
J Cumulative Count of Conforming Control Chart (CCC) - Calculating UCL and LCL Statistical Analysis Tools, Techniques and SPC 8
J IVD registration renewal in China China Medical Device Regulations 6
Nikki9154 MDSAP inquiry for China Contract Manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 4
R Tungsten from China DFARS Compliant? Various Other Specifications, Standards, and related Requirements 2
J Foreign Exporter - China to UK to Amazon US US Food and Drug Administration (FDA) 4
R Information on obtaining a market authorization for China China Medical Device Regulations 2
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
R China Quality Certification Various Other Specifications, Standards, and related Requirements 1
O Radio Modular approval in China China Medical Device Regulations 0
N Looking for Gamma sterilization facility in China ISO 13485:2016 - Medical Device Quality Management Systems 4
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
I Selling medical gown and mask in China China Medical Device Regulations 0
D Are Eye drops made in China classified as medical device in China? ISO 13485:2016 - Medical Device Quality Management Systems 0
F Medical Devices - Hong Kong - Post approval changes regulation (China's MOH) Other Medical Device Regulations World-Wide 3
N China - Start manufacturing before change approval? China Medical Device Regulations 3
C Looking for China Good manufacturing practice China Medical Device Regulations 1
Q Interpreting China Medical Device regulations/standards China Medical Device Regulations 1
J Quality Assurance in China - Developing a quality management system for a California company Misc. Quality Assurance and Business Systems Related Topics 9
J China NMPA medical device submission timelines and clearance rates China Medical Device Regulations 2
K China UDI Implementation for October 1st 2019 China Medical Device Regulations 4
D Document review on already approved registrations requested by China's NMPA? China Medical Device Regulations 3
T China ROHS exemptions - Are there any exemptions for ROHS 2 China? REACH and RoHS Conversations 0
E Original Brand Labeler (OBL) in China China Medical Device Regulations 2
Marc China - CFDA is now National Medical Products Administration or NMPA China Medical Device Regulations 7
D China - Where I can get NMPA complete structure/organogram chart and GB/YY format list China Medical Device Regulations 1
S China 2018 draft Amendments to the Regulations on the Supervision and Administration of Medical Devices China Medical Device Regulations 1
F China Clinical Trials Requirements Other Medical Device Regulations World-Wide 2
K ISO 9001:2015 AVL - New Chinese standards requiring all testing of materials be done in China ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
Z I need help with getting a CFS in China Manufacturing and Related Processes 2
F China Device Assisted Technology Clinical Trial China Medical Device Regulations 4
A Docs for Medical Device registration in China - List of certificates China Medical Device Regulations 6
K Registering a Software medical device (SaMD) in China China Medical Device Regulations 5
Edward Reesor Exporting from China - Unified Social Credit Code ISO 13485:2016 - Medical Device Quality Management Systems 2
C Are we required to obtain a Certificate of Free Sales for export to China? Other Medical Device Regulations World-Wide 6
Y List of Cell therapy and Gene Therapy products in South Korea and China Other Medical Device and Orthopedic Related Topics 1
P China drug packaging DMF China Medical Device Regulations 0
Gamula Biocompatibility GLP conform tests outside China China Medical Device Regulations 1
B China GB4943.1 Safety Requirements - PCB Markings China Medical Device Regulations 0
N China's CFDA - Medical Device Validation Requirements China Medical Device Regulations 8
F Information on China's Medical City Other Medical Device Regulations World-Wide 4
B Is ISO 15254:2009 a requirement for China for ophthalmic products market? China Medical Device Regulations 1
N Where to find a Qualified FDA Supplier Auditor located in China China Medical Device Regulations 7
Gamula CFDA Clinical Evaluation Report (China) China Medical Device Regulations 4
H Research Use Only (RUO) Medical Devices in China China Medical Device Regulations 7
B Strategy for Registration a Medical Device in China China Medical Device Regulations 2
JoCam Labeling Requirements for Medical Devices Made in China EU Medical Device Regulations 6
B FDA Listing of a Class I Medical Device in USA (Manufactured in China) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
Q Correlation between ASTM & China's GB (Guobiao) / YY Standards China Medical Device Regulations 4

Similar threads

Top Bottom