Batangas - Arkray PH

ARKRAY INDUSTRY INC.

ARKRAY Industry is a global leader in the manufacturing of diagnostic systems and reagents utilized by medical laboratories and hospitals across the world.

QUALITY SUPREMACY!

Challenge to ZERO defect outflow

High training quality output

Efficient manufacturing process

High-mix low-volume production

Superior product quality

Quick delivery

OUR PRODUCTS

OUR FACILITY

Established November 24, 2010, at First Philippine Industrial Park (FPIP)

LABORATORY

REAGENT LINE

INSTRUMENT LINE

R&D

TRAINING ROOM

WAREHOUSE

ISO 13485:2016

COMPLIANCE WITH GLOBAL STANDARDS

21 CFR 820

It ensures that all medical devices created and developed within the US market are safe and follow satisfactory quality processes at all stages of development. This is important for manufacturers to ensure they are producing medical devices which are effective and assure patient safety.

MDD (93/42/EEC)

Defines a “Medical Device” as any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings

IVDD (98/79/EC)

In vitro diagnostic medical devices (IVDs) are subject to the European Directive 98/79/EC (IVDD). A subgroup of medical products, their market access, use, and market surveillance is regulated.

CGMP

CGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

KGMP

KGMP means Korean good manufacturing practices requirements specified by KFDA regulations applicable to the Manufacture of the Licensed Product for Commercialization.

Phil GMP

Standards for manufacture and quality management of medical devices in the Philippines

COMPLIANCE WITH SOCIAL ACCOUNTABILITY

SMETA (SEDEX Members Ethical Trade Audit)
Wal-mart Compliant