Medical Device Market Requirements for Japan

The distribution of medical devices in Japan is regulated in accordance with the Pharmaceutical and Medical Device Act (PMD Act). The most recent revision to the PMD Act was made on August 1, 2021.

Medical Device Market Requirements for Brazil

Download our free Market Guidance Document for medical device regulatory requirements in Brazil. This guide outlines the compliance assessment steps in accordance with Ordinance 384/2020, the standard for the safety and performance of electronic medical equipment.

Download The Road to ‘Net Zero’ White Paper

In the urgent fight against climate change, the focus is on halting and not just reducing carbon emissions. With the Paris Agreement's 1.5°C target and 'net zero' goals, businesses and governments face mounting pressure to take action and be accountable for their carbon footprint.

White Paper: The Importance of Aligning a Pharmaceutical Audit Scope with the Correct Standard

Maintaining compliance and transparency in pharma supply chains is crucial. Quality audits of suppliers are vital to ensure high production standards. Choosing the right industry standard mitigates risk.

CCCEx Technical Decision Notice (TC 28-2021)

Stay informed about recent CCCEx technical decisions in China regarding explosion-proof products. Download our free English-translated guide for detailed insights.

White Paper: Responsible Sourcing in the Building and Construction Sector

Companies must meet rising demands for ethics, accountability, and regulations on environmental and social issues.

Top Ten Reasons Products Fail Compliance Testing & Certification

Intertek tests devices to standards. Surprisingly, over 90% of medical electrical devices fail first tests. Failures lead to market delays, costs, brand damage, and safety risks. This document explores common failures to help manufacturers improve design and manufacturing.

White Paper: Environmental Product Declaration

The construction industry's focus on sustainability has grown, leading to increased interest in Environmental Product Declarations (EPDs) to assess environmental performance. This white paper explains EPDs, their creation process, and challenges, with expertise from Intertek Assuris' global Sustainability Team.

Brexit changes to the European Medical Devices Market

Brexit has had a widespread impact on many industries; the electrical medical device market has been no exception. Download our new overview of key requirements for placing a new medical device on the Great Britain (England, Wales, and Scotland) markets as well as the Northern Ireland market.

FAQ: Safety Requirements for Children’s Clothing Sold in Europe

Under the EU General Product Safety Directive (GPSD 2001/95/EC), only safe products shall be placed on the market in Europe. As a result, many children’s products – including clothes – are required to comply with various safety standards that relate to security of attachments, cords & drawstrings, flammability and chemical safety.