What should health and life sciences entrepreneurs know about international regulations? — Introducing Terkko’s new partner Labquality
For any health and med tech manufacturer, regulatory compliance is key for successful business. Building quality and regulatory compliance into product development requires time but also vast understanding of complex regulations and standards. Terkko’s new partner Labquality is on a mission to ease the regulatory path for medical and in vitro diagnostic device manufacturers so that new products can make it safely to global markets, fast. Here we highlight three main things to consider when getting started with regulatory compliance – brought to you by Labquality’s regulatory experts.
1. Every product is different
According to MedTech Europe statistics there are currently more than 500,000 different medical devices services on the market. Obviously all new cases are unique and should be handled as such.
Usually, each regulatory compliance project begins with defining the product at hand from a quality and regulatory perspective. The first thing to define is the intended use of the product. The defined intended use is compared to the definition of a medical device in the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) – to see whether your product is considered a medical device or not. If it is, you should classify your device and recognize all relevant legal requirements, standards and guidance documents concerning your product.
2. Country and regional regulations differ
Applying for EU-wide sales approval, in regulatory terms CE marking, for a product is a demanding and laborious puzzle that often takes months of work. Furthermore, when thinking about entering global markets, the work usually doesn’t get easier. Different countries and regional areas have their own regulatory systems – challenging med tech manufacturers and service providers in mastering everything that is needed for successful regulatory compliance.
For example, in the US regulatory compliance is based on comparison to products already on the market (so called predicate device approach). At the same time in China, it is required to perform type testing and carry it out locally in China. Furthermore, Chinese type testing has its own procedures which are based on local legislation.
3. Allocating resources is essential
Above all regulatory compliance requires discipline and dedication. Whether you opt for investing in in-house or outsourced expertise, it’s essential that you have professional regulatory resources.
Through the partnership with Terkko, Labquality’s team will be providing the Terkko community support in questions related to regulatory, quality management and global sales approvals. Labquality’s regulatory expertise covers a wide range of countries and in addition to the EU, the team has experience in registering devices to over 40 countries including the US, Brazil, Chile, China, India, Iran, Japan, Russia, Singapore, South Africa, and the United Arab Emirates.
Get in touch to know more, and stay tuned for upcoming events.
Hanne Kankaanpää, Quality and Regulatory Affairs Manager
Anne Suorsa, Quality and Regulatory Affairs Manager