Worldwide Medical Device Regulatory Updates
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.
Singapore’s medical device market regulator, the Health Sciences Authority (HSA), is planning a new good distribution practice standard for medical devices that requires licensure of companies importing and supplying devices in the country.
At this moment the Trilogues, the negotiations between the European Parliament, the European Council and the European Commission regarding the Medical Devices and In-Vitro Diagnostic Devices Regulations, are still going on. As indicated in my previous blog post, no outcomes have been made public except for some rumors. Basically we must presume that all proposals are still being negotiated.
Back in 2012 and 2013, Emergo and other medical device industry news sources began reporting on an effort by the Association of Southeast Asian Nations (ASEAN) trade bloc to establish harmonized device registration systems across 10 countries in the region.
Following a successful legal case against the Brazilian government, some medical device manufacturers may now pay reduced registration and quality system inspection fees without having to request refunds from the country’s Ministry of Finance.
US medical device and pharmaceutical regulators are launching a new committee to more comprehensively address policy and implementation challenges associated with combination products.
The Indian Ministry of Health and Family Welfare has issued draft rules that establish registration and quality system requirements for medical devices and IVDs distinct from pharmaceutical products.
The Agencia Nacional de Telecomunicacoes (ANATEL) in Brazil has updated its labeling regulations for wireless products, including some medical devices.
The Health Sciences Authority (HSA), Singapore’s medical device market regulator, plans to change its import declaration requirements for medical devices and other healthcare products starting May 3, 2016.
The US Federal Trade Commission (FTC) has published an online tool designed to help developers of mobile medical and telehealth apps determine which laws and regulations pertain to their products.
The US Food and Drug Administration and the National Institutes of Health (NIH) have jointly proposed a new template for clinical trial sponsors to use for submitting Investigational Device Exemption (IDE) applications.