For certification review services compliant with standards under the Pharmaceuticals and Medical Devices Act, trust SGS Japan, known for its reliability and track record!
SGS Japan Inc. provides conformity assessment certification review services under the Pharmaceuticals and Medical Devices Act. Our company is one of the few certification bodies in Japan that can handle comprehensive medical device standards and regulatory standards (ISO 13485, Directive 93/42/EEC and Directive 98/79/EC: CE marking, FDA QSR agency inspections, ISO 13485 under CMDCAS). In addition to conformity assessment certification review services, we also offer product safety testing to confirm compliance with medical device safety standards and EMC testing services. As a leading company in testing and certification, we can provide one-stop support. We invite you to consider our third-party certification services as your partner. 【Features】 ■ One of the few in Japan capable of handling comprehensive medical device standards and regulatory standards ■ Experienced review staff ■ Trust and track record ■ Comprehensive medical device review services ■ Utilization of foreign auditors ■ One-stop service *For more details, please feel free to contact us.
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basic information
In April 2005, the revised Pharmaceutical Affairs Law was enacted, initiating a third-party certification system. When manufacturers and distributors handle designated medical devices and in vitro diagnostic drugs, they must apply for manufacturing and sales certification to a registered certification body recognized by the Ministry of Health, Labour and Welfare. After the application for manufacturing and sales certification, two reviews will be conducted: 1. Compliance evaluation (review of the certification application and attached documents) 2. QMS investigation for each manufacturer and manufacturing site After these reviews are completed, a certification number for the applied items will be issued. The scope of certification available at SGS Japan includes the following: ■ Anesthesia and respiratory devices ■ Dental devices ■ Medical electrical equipment ■ Facility equipment ■ Ophthalmic and vision devices ■ Reusable devices ■ Single-use devices ■ Home massage devices ■ Hearing aids ■ Radiation and imaging diagnostic devices ■ In vitro diagnostic drugs, etc. *For more details, please feel free to contact us.
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Company information
SGS is a global leading company in inspection, verification, testing, and certification. The history of SGS began in 1878 when it was established in France as a grain pre-shipment inspection company. With approximately 140 years of history, SGS has one of the largest scales and achievements as a leading company in inspection, verification, testing, and certification. Currently, it has over 2,650 offices and laboratories in more than 125 countries, with 98,000 staff members actively working. By leveraging its global network, SGS provides a variety of services to its customers, including chemical substance management, chemical testing and analysis of electrical and electronic equipment and materials, product safety, machinery safety, functional safety, EMC testing, certification for wireless communication devices, testing and analysis related to general consumer goods, third-party certification audits and inspections (for medical devices, in vitro diagnostic medical devices, pharmaceuticals, cosmetics, food safety, environmental and labor safety, sustainability, forest certification, security and business continuity, quality, second-party audits, training), food analysis and inspection, cosmetics and pharmaceuticals testing and analysis, environmental analysis, marine services, occupational health and safety audits, product certification and inspection services for industries, and inspection, analysis, and market research for oil and energy.
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