Refurbisher of medical devices in Japan

Ajit Basrur

Staff member
Admin
#1
Is it mandatory for a refurbisher of medical devices in Japan to be ISO 13485 certified? I am searching for this requirements in Japanese regulations but did not find it.

Thank you!
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
B Refurbisher (re-loader) of OEM X-Ray Tubes - Marketing to Canada ISO 13485:2016 - Medical Device Quality Management Systems 1
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 1
L Medical-grade power adapter labeling Other US Medical Device Regulations 2
dgrainger Informational UK - Medicines and Medical Devices Bill 2019-21 Other Medical Device Regulations World-Wide 0
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW EU Medical Device Regulations 7
S Call it refurbish or not? Medical Devices Manufacturing and Related Processes 2
C Registering Medical Devices in Australia and New Zealand - ANZTPA Other Medical Device Regulations World-Wide 0
T Loaded spring device - Active medical device? EU Medical Device Regulations 1
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 2
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
S Requirements for "Claims Guide" for medical devices Medical Device and FDA Regulations and Standards News 6
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
F Labelling requirements for a medical device containing fragrance allergens EU Medical Device Regulations 3
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
G Accelerated stability of medical devices Other Medical Device Related Standards 1
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 11
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
S The US FDA requirements on Disposal of a medical device US Food and Drug Administration (FDA) 1
E IEC 60601-1 - Unearthed Medical Device Metal Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
S FDA Requirements for Medical Device Label Reconciliation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Medical Device Registration in the UAE MoH Other Medical Device Regulations World-Wide 2
G Free Sales certificates for Medical Devices - List of countries EU Medical Device Regulations 4
JoCam Medical Device Distribution in the UK EU Medical Device Regulations 6
dgrainger Informational Parliament to vote on postponing new requirements for medical devices -17th April Medical Device and FDA Regulations and Standards News 1
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Direct to customer export of medical device (class I: prescription lenses + frame) US Food and Drug Administration (FDA) 2
J Validity / outcomes measure for custom made medical device ISO 13485:2016 - Medical Device Quality Management Systems 2
S Regulatory job in pharma vs. medical device US Food and Drug Administration (FDA) 16
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
S Regulatory job in pharma vs. medical device CE Marking (Conformité Européene) / CB Scheme 0
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 1
M Mexico Medical Device Registration Requirements Other Medical Device Regulations World-Wide 1
Q 21 CFR 821 Medical Device Tracking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D BS EN 62304 - Medical-Relevant Data C.5 - Definition of IEC 62304 - Medical Device Software Life Cycle Processes 5
S Discontinuation of the Predicate Medical Device Medical Device and FDA Regulations and Standards News 1
Similar threads


















































Top Bottom