Medical Devices in Japan - Conformity of QMS to ISO 13485

JeantheBigone

Quite Involved in Discussions
#1
I'm looking for confirmation of something I think is the case with regard to conformity of the QMS of a manufacturer marketing a device in Japan to ISO 13485. Since I can't read Japanese, I'm not 100 % positive that the following is true, but here goes......

Japan does not currently require conformity to ISO 13485, instead it has its own QMS which is described in MO 169. They are in the process of harmonizing, but for now it is not an issue if a manufacturer of a medical device marketed in Japan does not have ISO 13485.

Is that correct?
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
Ajit Basrur Refurbisher of medical devices in Japan Japan Medical Device Regulations 0
S Scope change in Japan - Class I disposable medical devices Japan Medical Device Regulations 0
T Testing bluetooth medical devices against Japan Radio Law requirements Japan Medical Device Regulations 2
J Requirements for Importing Research Use Only Medical Devices into Japan Japan Medical Device Regulations 1
A Japan Medical Devices Vigilance Regulations or Guidelines Japan Medical Device Regulations 4
A Aesthetic Treatment Medical Devices in Japan Japan Medical Device Regulations 2
A How does Japan PMDA classify Medical Devices - Classification Guidelines Japan Medical Device Regulations 6
M Biocompatibility of Medical Devices (ISO 10993 vs Japan requirement) Japan Medical Device Regulations 1
A Japan - Shonin question - Delay if Contract Manufacturer Moves? Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Japan Medical Devices Regulations Japan Medical Device Regulations 9
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 2
G Accelerated stability of medical devices Other Medical Device Related Standards 1
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 10
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
G Free Sales certificates for Medical Devices - List of countries EU Medical Device Regulations 4
dgrainger Informational Parliament to vote on postponing new requirements for medical devices -17th April Medical Device and FDA Regulations and Standards News 1
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
M Who needs a MDEL? How to buy and sell medical devices on my own Canada Medical Device Regulations 14
D Social Media Feedback process for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 6
M Post Market Surveillance for Class II Medical Devices Medical Device and FDA Regulations and Standards News 2
M Special Controls and Class II Medical Devices Medical Device and FDA Regulations and Standards News 17
dgrainger Informational Have your say on the UK's Medicines and Medical Devices Bill Medical Device and FDA Regulations and Standards News 0
L Packaging unsterile medical devices ISO 13485:2016 - Medical Device Quality Management Systems 6
R Expected life span of Medical devices - X-Ray based diagnostic medical devices ISO 13485:2016 - Medical Device Quality Management Systems 6
Marc Medical device vulnerability highlights problem of third-party code in IoT devices Other Medical Device and Orthopedic Related Topics 1
J UK Medicines and Medical Devices Bill - 2019 ISO 13485:2016 - Medical Device Quality Management Systems 0
dgrainger Informational UK's new Medicines and Medical Devices Bill Medical Device and FDA Regulations and Standards News 0
O Is it mandatory for Medical Devices to work properly after dielectric strength tests? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
F Medical Devices-South Africa _Post approval changes and Software Other Medical Device Regulations World-Wide 0
S IVF medical devices standards and test methods Medical Device and FDA Regulations and Standards News 4
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 0
M Selling Medical Devices in Puerto Rico US Food and Drug Administration (FDA) 3
J Searching Registered Medical Devices in Argentina Other Medical Device Regulations World-Wide 0
M Advertising medical devices in the U.S - Advertising regulations or guidance documents Other US Medical Device Regulations 3
Watchcat Impact of MDR on Availability of Medical Devices in EU EU Medical Device Regulations 5
dgrainger Informational MHRA updated guidance: Clinical investigations of medical devices – guidance for manufacturers Medical Device and FDA Regulations and Standards News 0
B QMS question in regards to multiple medical devices/products and N/A activities Other Medical Device Related Standards 12
J Integrity of electronic digital records - Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
Ronen E Legal counselling and Medical Devices Regulatory Affairs Other Medical Device Regulations World-Wide 2
S Service record requirements for Non-Serviceable Medical Devices CE Marking (Conformité Européene) / CB Scheme 1
T Coating of Medical Devices Other Medical Device and Orthopedic Related Topics 1
N CE marking colour for Medical Devices CE Marking (Conformité Européene) / CB Scheme 4
F Label work instruction - Medical Devices Manufacturing and Related Processes 1
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS – Danish Medicines Agency Ramps Up Capacity in Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational TGA presentation: Cybersecurity for medical devices Medical Device and FDA Regulations and Standards News 0
M MDR Medical devices Gap analysis ISO 13485:2016 - Medical Device Quality Management Systems 2
M Informational TGA-led IMDRF Personalised Medical Devices working group meets in Canberra Medical Device and FDA Regulations and Standards News 0
M Informational ANVISA – CONSULTA PÚBLICA No 730, DE 14 DE OUTUBRO DE 2019 – Registro de dispositivos médicos (Public consultation – registration of medical devices) Medical Device and FDA Regulations and Standards News 0
Similar threads


















































Top Bottom