Biocompatibility of Medical Devices (ISO 10993 vs Japan requirement)

#1
Does anybody know about the additional test requiremnt for the registration of medical device in Japan?

I know that there is some additional test or a kind of modification method to conduct biocompatibility testing for medical device .

Thanks
 
Elsmar Forum Sponsor

Michael Malis

Quite Involved in Discussions
#2
Does anybody know about the additional test requiremnt for the registration of medical device in Japan?

I know that there is some additional test or a kind of modification method to conduct biocompatibility testing for medical device .

Thanks
You are correct.
The current Japanese guidance document - “Test Methods for Biological Safety Evaluation of Medical Devices, Assessment of Medical Device, Notice 36” only partially the same as ISO 10993. It also has technical specifications to perform tests that different from ISO 10993.

Therefore, some regulators in Japan do not readily accept testing to ISO 10993 and asking to perform an additional testing for product to get approval.

You should contact a CRO that specializes in biocompatibility testing and performs these tests. This way you will get an idea of how to move forawrd in the best possible way in addition to ISO 10993. Also please check JIS (Japanese industrial standards) for any new guidance for your type of product.

I hope this helps,
Mike
 
Thread starter Similar threads Forum Replies Date
Ajit Basrur Is Biocompatibility study performed on medical devices for possible contaminants? Other Medical Device Related Standards 4
T Biocompatibility Testing for Implantable Medical Devices according to ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 4
K Biocompatibility Testing - Component Level or Assembled Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 7
C Biocompatibility Test for a Non Contact Medical Device US Food and Drug Administration (FDA) 11
D Biocompatibility requirements for a Class IIa medical device CE Marking (Conformité Européene) / CB Scheme 7
S Biocompatibility testing for nasal prongs made of medical grade silicone 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
T Biocompatibility for "Desktop" used Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 4
J Biocompatibility for Class I Non-Sterile Medical Device EU Medical Device Regulations 2
V Biocompatibility of Medical Device Internal Parts Other US Medical Device Regulations 9
M Biocompatibility 10993-1 vs. Sterilization Cycle - Medical Device in EU ISO 13485:2016 - Medical Device Quality Management Systems 6
M Medical Device Biocompatibility Testing - End Product or Components - ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 22
L Biocompatibility of Medical Device Other Medical Device and Orthopedic Related Topics 8
F Biocompatibility evaluation for Hardware/Interface Components? Other Medical Device Related Standards 2
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
Beliz Biocompatibility Testing for Laser Epilation Device EU Medical Device Regulations 2
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
K Biocompatibility Testing - Multile products of different sizes and shapes US Food and Drug Administration (FDA) 2
K Biocompatibility evaluation of gas pathways Medical Device and FDA Regulations and Standards News 5
Kuldeep Singh Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 7
Judy Abbott Activation of complement at 90 min - BSI requested for justifications to support the biocompatibility of the device EU Medical Device Regulations 2
Judy Abbott Can any one help me with an urgent BIOCOMPATIBILITY Impact assessment? Internal Auditing 9
S ISO 10993 Biocompatibility Evaluation - Electronic thermometer Other Medical Device Related Standards 3
shimonv Referring to previously submitted biocompatibility results in a new 510(k) submission Other US Medical Device Regulations 1
I ISO 10993 Biocompatibility Requirements - manufacturing process chemicals Other Medical Device Related Standards 8
R 510(k) Biocompatibility vs Cleaning Validation Other Medical Device Related Standards 4
K Biocompatibility classification for Lancet CE Marking (Conformité Européene) / CB Scheme 7
F Sample Size for Biocompatibility Tests Other Medical Device Related Standards 4
F Biocompatibility Device Categorization: Priming with Blood Other Medical Device Related Standards 1
W Biocompatibility Risk Analysis for Clinical Practitioner 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F Biocompatibility on aged devices Other Medical Device Related Standards 3
Gamula Biocompatibility GLP conform tests outside China China Medical Device Regulations 1
I Biocompatibility Impact on Autoclaved Silicone Other Medical Device Related Standards 3
D Should Biocompatibility Tests be performed on Production Samples? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
R What is the expectation for Biocompatibility Testing when switching Suppliers? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
R Biocompatibility - ISO 10993 and SVHC Requirements Other Medical Device Related Standards 4
planB Biocompatibility: Blue Book Memorandum #G95-1 superseded by new FDA guidance Other Medical Device Related Standards 1
S ISO 10993-1: External Communicating Device biocompatibility test requirements Other ISO and International Standards and European Regulations 4
M Biocompatibility - why are animal studies necessary? Other Medical Device and Orthopedic Related Topics 11
R Biocompatibility Test of Blue Gown vs Blue Drape 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R FDA Biocompatibility questions for Surgical Gown 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Biocompatibility tests in AAA LAC Laboratory ISO 13485:2016 - Medical Device Quality Management Systems 6
B Biocompatibility for Packaging Materials Other Medical Device Related Standards 3
J Biocompatibility Evaluation component other than Testing Other Medical Device Regulations World-Wide 1
J Grouping Products and Testing Sterile and Biocompatibility - Validating Products Other Medical Device Regulations World-Wide 3
S Laminaria - Is a Biocompatibility Study Required? EU Medical Device Regulations 6
M Biocompatibility in Respiratory Products - Help interpreting whitepaper IEC 60601 - Medical Electrical Equipment Safety Standards Series 22
S Laminaria - Biocompatibility Study? Imported Legacy Blogs 1
M Three final products in one biocompatibility test? Other Medical Device and Orthopedic Related Topics 2
S Selecting materials for implants to comply with ISO 10993 biocompatibility Other Medical Device Related Standards 4
S Laminaria Stick (Cervical Dilator) - Biocompatibility Test required? ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom