MDSAP Certificate

MDSAP Certificate

MDSAP Certificate

Product catalog summary
Certificate Overview: This document is a certification issued by TÜV SÜD America, Inc. to Beijing Sano Laser S&T Development Co., Ltd. It certifies the company's quality management system for the design, development, production, distribution, and servicing of various medical devices.
Scope of Certification: The certification covers devices such as Diode Laser Hair Removal Systems, Dermal Cooling Systems (Cryojet Plus), Powered Muscle Stimulators (Hi-Emt Magshape), CO2 Laser Therapy Systems, picosecond Nd: YAG Lasers, Radio Frequency Systems, and Cryolipolysis Fat Slimming Machines.
Standards and Regulatory Authorities: The certification is based on ISO 13485:2016 standards and is recognized by regulatory authorities in Australia, Brazil, Canada, Japan, and the USA. Specific regulatory requirements include Australia's Therapeutic Goods Regulations, Brazil's ANVISA regulations, Canada's Medical Device Regulations, Japan's MHLW Ministerial Ordinances, and various US FDA regulations.
Validity: The certificate is effective from December 2, 2024, and expires on December 1, 2027.
Regulatory Requirements: The document outlines specific audit and certification criteria for each country, including full quality assurance procedures, good manufacturing practices, vigilance requirements, and specific parts of the US Code of Federal Regulations (CFR).
Facility Information: The certified facility is located in Beijing, China, and is identified by the REPs Facility ID: F007554.
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Catalog excerpts

MDSAP Certificate-1

MDSAP | MEDICAL DEVICE SINGLE AUDIT PROGRAM | Certification Mark: Beijing Sano Laser S&T Development Co.,Ltd. Room 7-201,No.1,Caida 3rd Street,Nancai Town Shunyi District 101300 Beijing PEOPLE'S REPUBLIC OF CHINA Design and Development, Production, Distribution, and Servicing of Diode Laser Hair Removal System for Medical Use, Dermal Cooling System (Cryojet Plus), Powered Muscle Stimulator (Hi-Emt Magshape), CO2 Laser Therapy Systems, picosecond Nd: YAG Laser, Radio Frequency System, Cryolipolysis Fat Slimming Machine Regulatory Authority(ies): Australia TGA, Brazil ANVISA, Health Canada, Japan MHLW / PMDA, USA FDA. See attached for listing of specific regulatory requirements. The Certification Body of TUV SUD America Inc. certifies that the quality management system of the manufacturer listed above has been audited against the stated criteria and found to conform to those criteria for the scope of certification listed. For details and certificate validity see: www.tuvsud.com/ps-cert?q=cert:QS6 004064 0005 Rev. 00 TUV SUD America Inc. is an MDSAP Recognized Auditing Organization. REPs Facility ID: Report No.: Effective Date: Expiry Date: TUV SUD America, Inc. • 401 Edgewater Place Suite #500 • Wakefield • MA 01880 • USA • www.tuvsud.com

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MDSAP Certificate-2

ZERTIFIKAT ♦ CERTIFICATE ♦ iSltlf* ♦ CEPTMcDMKAT ♦ CERTIFICADO ♦ CERTIFICAT MDSAP | MEDICAL DEVICE SINGLE AUDIT PROGRAM | Regulatory Requirements: Audit/Certification CriteriaAustralia Therapeutic Goods (Medical Devices) Regulations 2002 - Schedule 3, Part 1 (excluding Part 1.6) - Full Quality Assurance Procedure Brazil - RDC ANVISA n. 665/2022 - Good Manufacturing Practices Canada - Medical Device Regulations - Part 1- SOR 98/282 - MHLW Ministerial Ordinance No. 169 (2004), as amended by MHLW Ministerial Ordinance No.60 (2021) United States - 21 CFR Part 803 Facility(ies): Beijing Sano Laser...

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All Beijing Sanhe Beauty catalogs and technical brochures

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.