Certificate JP23/00007174
The quality management system of
Kyoto Hongchuang Clinic
Head Office. 9-3 Shimomura Morimoto, Morimoto cho, Xiangri City, Kyoto, Japan
Facility number: T150-0043
has been assessed and certified as meeting the requirements of
MDSAP (ISO 13485:2016)
Australia: Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 3, Part 1 - Full Quality Assurance System
SGS
Brazil: RDC ANVISA n. 665/2022 - Good Manufacturing Practices, RDC ANVISA n. 551/2021, RDC ANVISA n. 67/2009 - Vigilance
Canada: Medical Device Regulations SOR/98-282, Part 1
Japan: MHLW Ministerial Ordinance No.169 (2004), as amended by MHLW Ministerial Ordinance No.60 (2021)
Japan PMD Act (as applicable)
USA: 21 CFR Part 803-Medical Device Reporting; 21 CFR Part 806 - Reports of Corrections and Removals; 21 CFR Part 807
(Subparts A to D) - Establishment Registration and Device Listing, 21 CFR Part 820 - Quality System Regulation, 21 CFR Part 821
-Device Tracking
For the following activities
The Scope of Registration appears on page 2 of this certificate
This certificate is valid from Effective date 2023-05-25 until Expiry date 2026-04-20 and remains valid subject to satisfactory
surveillance audits.
Issue 1. Certified since 2023-05-25
Certified activities performed by additional sites are listed on subsequent pages.
Authorised by
Head of Notified Body 1639
SGS United Kingdom Ltd
Rossmore Business Park Ellesmere Port, Cheshire, CH65 3EN, UK
1+44 (0)151 350-6666-www.sgs.com
SGS UK LTD is recognised under the Medical Devices Single Audit Program. The validity of this certificate can be verified at www.SGS.com
MDSAP
MDSAP
SGS
This document is an authentic electronic certificate bor Client business purposes use only. Printed version of the electronic certificate are permitted and will be considered as a copy
This document is issued by the Company subject to SGS General Conditions of certification services available on Terms and Conditions | SGS. Attention is drawn to the limitation of
lability, indemnification and jurisdictional clauses contained therein. This document is copyright protected and any unauthorized alteration, forgery or falsification of the content or
appearance of this document is unlawful
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