The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is the central Regulatory authority that oversees medical device regulations in New Zealand.

In New Zealand, medical devices are classified according to their potential risk(s) to the human body. They range from Class I, which are low-risk devices, to Active Implantable Medical Devices (AIMDs), which are high-risk devices. A New Zealand sponsor must identify the appropriate risk classification for their medical devices.

The medical device Regulatory framework in New Zealand is built to ensure that medical devices sold in the country are safe and fit for their intended purposes. The Medicines Act, 1981 and its revisions, the Medicines Regulations, 1984, and the Medicines (Database of Medical Devices) Regulations, 2003 govern New Zealand’s medical device Regulatory system.

Medical devices must be reported to the Web Assisted Notification of Devices (WAND) database, which is managed under the Regulatory framework of the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).

Governance on paper is designed around time and is continually evolving. New laws are born, standards evolve, and aligning with the ever-changing landscape gives the feeling of not catching up. However, an opposite situation is possible – foreseeing these changes; acting rather than waiting for the same to unfold; making you one step ahead of all your competitors.

The world of medicine relies on a delicate balance between the effectiveness of drugs and their safety for patients. Pharmacovigilance, the science of monitoring drug safety, plays a crucial role in this equation. At the heart of pharmacovigilance lie the databases that store and analyze vital information on adverse drug reactions (ADRs).

The journey of pharmacovigilance databases is a fascinating one, marked by continuous advancements in technology and a growing understanding of drug safety. Let's take a trip down memory lane:

The journey of a drug from its conception to its entry into the global market is a complex and multifaceted process, fraught with challenges and governed by stringent regulations. Pharmacovigilance (PV) plays a critical role in this journey, ensuring that the safety and efficacy of pharmaceutical products are maintained at every stage. In this blog, we will explore the drug development process through the lens of pharmacovigilance and its significance in the global market.

GxP stands for "Good Practices," and the "x" can be replaced with various letters to denote specific areas, such as Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Distribution Practice (GDP), among others.

In the dynamic landscape of pharmaceuticals, ensuring product quality, safety, and regulatory compliance is paramount. A robust network of suppliers and vendors plays a crucial role in this ecosystem. However, the challenge lies in ensuring these partners meet the necessary quality standards and adhere to regulatory requirements. Enter vendor risk assessment—a strategic practice that safeguards compliance and quality.

The United States Food and Drug Administration (US FDA) released the highly anticipated revised Quality Management System Regulation (QMSR) in February 2024. The updated regulation serves as the new set of Good Manufacturing Practices (GMP) guidelines of the US FDA for medical devices, effectively replacing the previous set of Quality System Regulations (QSR). The US FDA QMSR now aligns more closely with the ISO 13485:2016, the international standard for medical device Quality Management System (QMS).