Hankyu Hanshin Express Narita Cargo Center has obtained Medical devices Manufacturing Registration, ISO 13485 accreditation, specially controlled medical devices distributing and leasing approval and cosmetics manufacturing approval. This means that Narita Cargo Center has developed and maintains the capacity to store and manage medical devices and cosmetics, ensuring quality and safety. Hankyu Hanshin Express provides high quality and high added value medical device and cosmetics logistics services.

1. Medical devices manufacturing Registration
   Following the amendment to the Pharmaceutical Affairs Act（the current Pharmaceutical and Medical Device Act）in April 2005, operators are required to obtain approval for packaging, labeling and storing medical devices (including for businesses where sales and distribution are separated while logistics is independent). This amendment to the Pharmaceutical Affairs Act has enabled manufacturers, importers and distributors of medical devices to fully entrust and commission logistics providers that have Medical devices manufacturing registration(formerly known as "medical device manufacturing approval (packaging, labeling and storage)") with tasks such as packaging, labeling and storage.

   ※Following the amendment to the Pharmaceutical and Medical Device Act in November 2014, changed from Medical devices manufacturing "authorization" to "registration".

   Details of Registration

   • Registration gained: Medical device manufacturing Registration
   • • Accredited facility:
       1) Hankyu Hanshin Narita Cargo Center
       2) Hankyu Hanshin Osaka Cargo Terminal
       3) Minami Funabashi Cargo Center
   • • Approval/Registration Date:
       1) April 1, 2005
       2) August 6, 2018
       3) March 17, 2022

2. ISO13485 (Medical devices quality management)
   Additional requirements specifically for handling medical devices were added to the quality management systems standard ISO9001 to create ISO13485 on the grounds that medical devices have a significant impact on health and quality of life. (More specifically, requirements concerning items such as operational environment, product and service provision management, traceability and operational improvements have been added)
   Medical devices here include a variety of devices used for medical care including devices such as syringe needles and catheters, machinery such as X-ray generators, materials such as dental filling, and extracorporeal diagnostic agents such as pregnancy test kits.

   • Accredited standard: ISO13485-2016
   • Accredited department: Medical device team, Hankyu Hanshin Narita Cargo Center
   • Accredited fields: Services associated with labeling, sorting and packaging of medical devices
   • Adjudicating authority: Japan Management Association Quality Assurance Registration Center (JMAQA)
   • Registration approval date: April 11, 2005

   

3. Specially controlled medical devices distributing and leasing approval
   Acquisition of the accreditation enables Hankyu Hanshin Express to directly deliver imported medical devices to hospitals, doctors and research centers in addition to manufacturer/distributors or distributors, expanding our range of services.

   Details of approval

   • Approval gained: Specially controlled medical devices distributing and leasing approval
   • • Accredited department:
       1) Medical device team, Hankyu Hanshin Narita Cargo Center
       2) Hankyu Hanshin Osaka Cargo Terminal
   • • Approval date:
       1) May 31, 2007
       2) March 22, 2018

4. Cosmetic Products Manufacturing Authorization
   This authorization enables Hankyu Hanshin Express to repackage and relabel imported cosmetic products, as well as insert written product information.

   Details of accreditation

   • Approval gained: Cosmetic Products Manufacturing Authorization (packaging, labeling and storage)
   • Accredited department: Narita Cargo Center
   • Registration approval date: July 25, 2019