Instancias reguladoras El Ministerio de Salud (MSP) es el ente rector de la política pública de salud. La Agencia Nacional de Regulación Control y Vigilancia Sanitaria (ARCSA) realiza el control de registro sanitario de los dispositivos médicos y otros productos.…
Regulatory authority The Ministry of Health (MSP) is the governing body responsible for public health policy. The National Agency for the Regulation and Sanitary Surveillance and Control (ARCSA) controls the sanitary registration of medical devices, amongst other products. In addition,…
A period of public consultation has been held1 on proposals to amend Korea’s safety and adverse event reporting requirements in order to clarify: the procedure for the collection of safety-related information by specifying clearly what information must be submitted to…
On 18 August 2017, President Trump signed HR 2430, the FDA Reauthorization Act of 2017 (FDARA), which became Public Law No 115-521. Principally, FDARA re-authorises the Food and Drug Administration’s (FDA’s) user fee programmes, including the Medical Device User Fee…
Regulatory authority Health Canada is the Federal department responsible for reviewing medical devices and in vitro diagnostic devices (IVD devices) to assess their safety, effectiveness and quality before being authorised for sale in Canada. Within Health Canada, the Health Products…
Introduction The Brazilian post-market surveillance (PMS) system, known as Technovigilance, is a monitoring system for adverse events and technical complaints of medical devices and in vitro diagnostic (IVD) products in the post-market phase. Its purpose is to ensure the adoption…
The Saudi Food and Drug Authority has drafted a document for comment purposes that is entitled, Project on Guidance on Requirements for Following Up and Closing Medical Devices Field Safety Notices (FSNs)1. The draft guidance, which applies to local manufacturers…
Towards the end of 2017, the Ministry of Food and Drug Safety (MFDS) in the Republic of Korea issued a number of proposed regulatory amendments for public comment; details are as follows: Proposed amendments to the Regulations on Approval, Notification…
A number of significant changes have been proposed1 to the Regulations on the Supervision and Administration of Medical Devices in an effort, inter alia, to align these Regulations with the improvements recommended in the In-Depth Reform of the Review and…
On 15 January 2018, version 2.0 of the Uniform Recall Procedure for Therapeutic Goods (URPTG) came into effect1, replacing the 2004 version. The new version of the URPTG must now be followed by sponsors. The URPTG provides a consistent approach…
Interested parties have until 26 February 2018 to comment on a proposed programme for manufacturer reporting of certain device malfunction Medical Device Reports (MDRs) in summary format (i.e. the Voluntary Malfunction Summary Reporting Program)1. This proposed, voluntary programme reflects the…
On 6 April 2018, the Food and Drug Administration’s (FDA’s) adverse event coding system will be amended, and corresponding updates will be made to the Center for Devices and Radiological Health’s electronic Medical Device Reporting (eMDR) system1. Initially, changes will…
Public Warning and Notification of Recalls Under 21 CFR [Code of Federal Regulations] Part 7, Subpart C; Draft Guidance for Industry and FDA [Food and Drug Administration] Staff has been published for a period of public consultation1. When finalised, the…
The adverse event codes developed by the International Medical Device Regulators Forum (IMDRF)1 are scheduled to be implemented into the European vigilance reporting system from the second quarter of 2018, with a one-year transition period until their official enforcement2. Ideally,…
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 Singapore’s healthcare regulatory framework consists primarily of: the regulator, which is the Ministry of Health along with its statutory boards; and the regulated, which are the public and private healthcare providers. Medical devices are regulated under the Health…
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…
The Saudi Food and Drug Authority has finalised and published eight new guidance documents relating to medical devices1: MDS-G7, Guidance on Medical Devices Bundling Criteria; MDS-G12, Guidance on Importation Requirements for Chemicals Used in Medical Devices Applications; MDS-G13, Guidance for…
On 17 April 2018, the Food and Drug Administration released its Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health1. This new Action Plan sets out the Agency’s vision for how it can continue to enhance its programmes and…
An immediately-in-effect guidance for industry has been published entitled Compliance Policy for Combination Product Postmarketing Safety Reporting1,2. This guidance outlines the Food and Drug Administration’s (FDA’s) compliance policy for Combination Product Applicants and Constituent Part Applicants and activities under Title…
Health Canada has informed stakeholders, notably manufacturers and importers of medical devices, that it intends to propose regulatory changes to strengthen the post-market surveillance and risk management of medical devices in Canada1. These proposed changes to the Medical Devices Regulations…
