Manufacturers of Class IV human immunodeficiency virus (HIV) rapid diagnostic tests (RDTs) intended to be used at the point of care and/or for self-testing have been provided with guidance1 on the analytical and clinical data, and the device labelling, required…
As a first step towards implementing the new European Regulations on medical devices and in vitro diagnostics (IVDs), Finland made some amendments to its Law on health care equipment and supplies on 20 December 20171. The amended Law clarifies Valvira’s position as…
Regulatory authority The State Health Care Accreditation Agency under the Ministry of Health is the Competent Authority for medical devices and in vitro diagnostic medical devices. Its main responsibilities include: the registration of medical devices; maintaining a medical device…
Regulatory authority After its independence in 1947, the Pakistan Government adopted India’s Drugs and Cosmetics Act, 1940. However, owing to the Act’s limitations, the Government of Pakistan enacted a completely new Drugs Act in 1976, which was administered by the Drug…
Three guidance documents have been finalised and published by the International Medical Device Regulators Forum (IMDRF) on 27 March 2018. These documents are1: IMDRF/Registry WG/N46 FINAL:2018, Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making; IMDRF/RPS WG/N13…
Lists of examples of in vitro diagnostic medical devices (IVDs) that are classified into classes A–D under the Medical Device Administrative Control System (MDACS) have been posted on the Department of Health website1. Each list states that the examples provided…
Sponsors of Class 1–3 in-house in vitro diagnostics (IVDs) have been provided with guidance1 on how to update their existing notification that has been lodged with the Therapeutic Goods Administration (TGA). The guidance gives step-by-step instructions for using the online…
The Food and Drug Administration (FDA) has finalised two guidance documents that provide recommendations for designing, developing and validating tests that use next generation sequencing (NGS) to scan a person’s deoxyribonucleic acid (DNA) to diagnose genetic diseases, which are usually…
