ISO 14001 is the leading standard for environmental management systems. 

This standard covers human rights and employee rights. The element at the heart of SA8000 is the concept of Corporate Social Responsibility (CSR). It considers the social and environmental aspects of company management and all other factors that may affect the employee of a given company. Implementation of this standard makes business ethical and employee-friendly, which Mercator Medical Thailand pays full attention to.

• Labor Standards

• Health and Safety

• Environmental Performance

• Business Ethics

Thai FDA is responsible for the protection of the consumer's health and safety by ensuring the quality and efficacy of health products.

International Organization for Standardization 9001 and 13485 – the Quality Management System for Medical Devices developed in accordance with the requirements of ISO 9001, ISO 13485 is an international standard containing requirements for medical devices intended to guarantee the highest quality of products and their compliance with the law and customer expectations.

EU-type examination certificate – EU-type examination is a procedure whereby a notified body ascertains and attests that the product, including its technical documentation and relevant life-cycle processes, as well as a representative sample of the envisaged product, complies with the relevant provisions. EU type examination certificate is for Personal Protective Equipment (PPE), which Mercator Medical Thailand’s product is classified as Category III.

As far as we are concerned, Mercator Medical Thailand is the only Thai manufacturer qualified for NFPA 1999 standard which is the standard of protective clothing and ensembles for emergency medical operations. NFPA 1999 contains a significantly high standard with strict auditing rules and regulations which we see as challenging and our gloves are able to meet the requirements of this standard.

EU regulations require the use of CE marking. The CE marking indicates that the product can be legally sold in any EU country, therefore, the gloves must be marked with this symbol.

Like CE marking for EU countries, UKCA marking is for Great Britain. We are registered with UK’s NHS which allows us to have UKCA marking.

The GMP rules ensure high quality and the highest purity of the materials used to produce medical and protective gloves, and full control of the origin and quality of raw materials and the entire manufacturing process.

ISO 14001 is an internationally agreed standard that sets out the requirements for an environmental management system. It helps organizations improve their environmental performance through more efficient use of resources and reduction of waste, gaining a competitive advantage and the trust of stakeholders. We are in the process of this certification.

ISO 45001 is an international standard that specifies requirements for an occupational health and safety (OHS) management system. It aims to improve working conditions, minimize occupational risks, and enhance health and safety protection for employees.

The FDA (Food and Drug Administration) is the U.S. standard setting for safety and quality requirements for products such as food, drugs, medical devices and cosmetics. Its goal is to protect the health of consumers through rigorous inspections and regulations, ensuring that products comply with the highest standards.

CMDCAS (Canadian Medical Devices Conformity Assessment System) is Canada's medical device conformity assessment system. Its purpose is to ensure that products meet Canada's stringent health and safety requirements. CMDCAS certification confirms the high quality and compliance of products with Health Canada regulations.

MDSAP (Medical Device Single Audit Program) is an international audit program for medical device manufacturers. It enables a single audit that meets the regulatory requirements of several countries, such as the US, Canada, Brazil, Japan and Australia. MDSAP certification confirms product compliance with global safety and quality standards.

The Therapeutic Goods Administration (TGA) is the Australian regulatory agency responsible for the inspection and certification of drugs, medical devices and other therapeutic products. TGA certification confirms that a product meets strict safety, quality and efficacy requirements, allowing it to be sold legally in the Australian market.

JSFL 370 is a Japanese standard regulating food contact materials. It specifies requirements for safety and chemical compatibility, ensuring that products meet Japan's strict hygiene and health standards. JSFL 370 certification confirms that materials are safe for use in the food industry.