Since its inception, Horien Biotech has integrated Quality Management System (QMS) principles into its core manufacturing operations. We are fully committed to implementing and maintaining compliance with ISO 13485, ISO 14001, and Medical Device Good Manufacturing Practice (GMP / QMS) standards.

Key quality milestones and regulatory achievements:

‧ Dec 2006 | Horien Biochemical Technology Co., Ltd. was established.
‧ Aug 2007 | Obtained Factory Registration Certificate (No. 99-702409-00).
‧ Feb 2008 | Obtained Medical Device Manufacturing License (No. 6117061324).
‧ Mar 2009 | Achieved ISO 9001 and ISO 13485 certifications.

‧ Apr 2009 | Awarded vocational training grant under the Council of Labor Affairs "Immediate Recharging Plan" (Grant No. 9801569A-3-1).
‧ Apr 2009 | Obtained Medical Device GMP Certification from the Department of Health (DOH).

‧ Jun 2009 | "Horien" Gennu-Plug® officially classified as a Class III implantable medical device by the DOH.
‧ Sep 2009 | "Horien" Gennu-Plug® obtained DOH Medical Device License (No. 002787).

‧ Nov 2009 | Awarded Small Business Innovation Research (SBIR) grant by the Ministry of Economic Affairs (MOEA).
‧ Dec 2009 | "Horien" Gennu-Plug® awarded the 2010 Symbol of National Quality (SNQ).
‧ Jan 2010 | "Horien" Gennu-Plug® awarded the 2011 Symbol of National Quality (SNQ).

‧ Oct 2011 | "Horien" Collagen Matrix Dental Dressing obtained DOH Medical Device License (No. 003459).

‧ Nov 2011 | Sterile Collagen Matrix achieved CE Mark Certification from DNV.

‧ Jan 2012 | "Horien" Gennu-Plug® awarded the 2012 Symbol of National Quality (SNQ).

 ‧ Mar 2012 | Received Biotech R&D Industrialization Subsidy from the Industrial Development Bureau (IDB), MOEA.

 ‧ Mar 2012 | Recertified for ISO 9001:2008 and ISO 13485:2003.

‧ May 2012 | Renewed GMP certification.

‧ May 2012 | Renewed GMP certification and obtained inspection approval for new product line expansion.

‧ Jul 2012 | Sponsored the Taipei Medical University Oral Health Service Team for medical outreach in Shitan Township, Miaoli County.

‧ Oct 2012 | Participated in the Moonstar Foundation "Light Up Your Heart" charity initiative.

‧ Dec 2012 | "Horien" Collagen Matrix Dental Dressing awarded the 2012 Symbol of National Quality (SNQ).

‧ Mar 2013 | Selected for the Biotech R&D Industrialization Guidance Program by IDB, MOEA.

‧ May 2013 | "Sterile Collagen Matrix" renewed CE Mark Certification issued by DNV.

‧ Aug 2013 | "Horien" Collagen Matrix obtained DOH Medical Device License (No. 004212).

‧ Jan 2014 | Selected for the Biotech R&D Industrialization Guidance Program by IDB, MOEA (2014).

‧ Jan 2015 | Renewed GMP certification.

‧ Jan 2015 | Successfully recertified ISO 13485 through DNV.

‧ Feb 2017 | "Horien" Extracellular Membrane obtained Medical Device License from the Ministry of Health and Welfare (MOHW).

‧ Mar 2018 | "Horien" Extracellular Membrane passed GMP recertification inspection.

‧ Mar 2019 | "Horien" Gennu-Plug obtained NMPA medical device registration in China.

‧ Jan 2022 | "Horien" Extracellular Membrane awarded the 24th Symbol of National Quality (SNQ).

‧ Jan 2024 | Quality Management System (QMS) verified by the Taiwan Food and Drug Administration (TFDA, MOHW).

‧ Oct 2024 | Completed manufacturing facility and equipment expansion.

‧ Nov 2024 | Granted Patent (No. I860515): "Method for Fabricating Collagen Bio-ink, Collagen Bio-ink, and 3D Bio-printing Method".

‧ Nov 2024 | Granted Patent (No. I863577): "Biodegradable Double-J Stent and Method of Manufacturing the Same".

‧ Jan 2025 | Officially listed on the Emerging Stock Market in Taiwan (Stock Code: 7814).

‧ Jul 2025 | Successfully audited by DNV and renewed ISO 13485 certification.

‧ Nov 2025 | Officially recognized by the Ministry of Economic Affairs as a "Technology Company with Market Potential" (Notified by TWSE).

‧ Jun 2026 | Obtained Thai FDA Class 4 (highest risk) medical device certificates for three products: "Horien" Collagen Matrix, "Horien" Extracellular Membrane, and "Horien" Collagen Bone Graft Matrix.

  

‧ Aug 2026 | Granted US Patent: "Biodegradable Double-J Stent and Method of Manufacturing the Same" (Application No. 18/444,629).