Kusatsu/Shiga, Japan – April 24, 2019 -  Takara Bio Inc. (Takara Bio) announced that Takara Biotechnology (Dalian) Co., Ltd. (Dalian city, China, hereafter “Takara Biotechnology (Dalian)”), a wholly-owned subsidiary of Takara Bio has acquired ISO 13485:2016 certification, an international standard for quality management system of medical devices and diagnostic pharmaceuticals.


  Takara Biotechnology (Dalian) is a core manufacturing facility for research reagents sold by Takara Bio group. It acquired ISO 9001:2015 certification, an international standard for quality management system in 2015 and subsequent ISO 13485 certification this time in order to meet the requirements for in vitro diagnostic pharmaceuticals.


  Takara Bio will provide high-quality reagents and services for the life sciences with focuses on quality management system.



ISO 13485:2016

Organization registered

Takara Biotechnology (Dalian) Co., Ltd.

Scope registered

Contracted manufacturing for molecular biology reagents applicable to in vitro diagnostic pharmaceuticals

Date of registration

March 26, 2019

Accreditation no.



SGS United Kingdom Ltd.

Overview of Takara Biotechnology (Dalian)

Company name

Takara Biotechnology (Dalian) Co., Ltd.


19-No.2 Dongbei Street, Dalian Economic and Technical Development Zone, Dalian city, Liaoning, 116600, China

Date established


Number of employee

514 (As of March 31, 2019)

Business description

Manufacture of research reagents, etc.