The Unique Device Identification (UDI) system is an international standard that assigns a unique code to each medical device to improve patient safety and streamline product tracking and recall. In China, the National Medical Products Administration (NMPA) has implemented UDI guidelines and regulations for medical devices to enhance safety and quality control.
- May 17, 2023 Medical Devices
- May 15, 2023 Pharmaceuticals, Regulatory Labeling
Abbreviated SmPCs (Summary of Product Characteristics) form an important source of information for healthcare professionals and patients alike. These documents provide a summary of key information about a medicinal product, including its indications, posology, contraindications, and adverse reactions.
- May 12, 2023 Medical Devices
An operation manual is in many ways referred to as labeling, Instructions for Use (IFU), or a user guide. It is a document that is instrumental in achieving the safety of a medical device and illustrates the general ways to use or operate a medical device.
- May 12, 2023 Medical Devices
A 510(k) or a pre-market notification is a submission made to the United States Food and Drug Administration (US FDA) to demonstrate that the device to be marketed is safe and effective, that is, substantially equivalent to a legally marketed or a predicate device. The following are the three (03) types of 510(k) that a medical device manufacturer can submit:
- May 12, 2023 Medical Devices
In effect from March 1, 2023, the technical dossier must be planned as described in the Brazilian Health Regulatory Agency, or the Agência Nacional de Vigilância Sanitária (ANVISA)’s new medical device regulation, …
- May 12, 2023 Medical Devices
Custom-made medical devices in Australia are regulated by the Therapeutic Goods Administration (TGA). The TGA has changed the way of regulating custom-made medical devices in Australia, and the changes affect anyone who is manufacturing, importing, or supplying custom-made medical devices, including healthcare providers.
- May 12, 2023 Publishing & Submissions, Regulatory Software & Services
Small and medium-sized life science companies are the backbone of the Healthcare industry, but Regulatory hurdles often hamper their potential for ground-breaking innovation. These companies face an uphill battle to bring their products to markets, with limited resources and expertise in navigating the complex Regulatory landscape.
- May 12, 2023 Medical Devices
What is the Role of Cybersecurity in Medical Devices?
The 510(k) clearance process is a Regulatory pathway used by the United Sta
- May 9, 2023 Regulatory Artwork Services, Regulatory Affairs
Regulatory artwork services form a critical component of the Pharmaceutical industry, ensuring that the packaging artwork of medicinal products is accurate, complete, and compliant with the Regulatory requirements.
- May 5, 2023 Pharmaceuticals, Regulatory Affairs, Publishing & Submissions
As the world continues to move towards digitalization, electronic submissions are becoming the norm for Regulatory Bodies across countries. In Europe, the European Union (EU) has established a mandatory electronic Common Technical Document (eCTD) format for the submission of medicinal products’ Regulatory information.