Comments have been sought on a Draft Resolution of the Ministry of Health and Social Welfare establishing a technical regulation on the labelling requirements for certain in vitro diagnostic (IVD) and other reagents1. The text sets out draft labelling requirements…
Guidance has been drafted to recommend the addition of a specific safety statement to the product labelling of certain ultrasonic surgical aspirator devices1,2. The proposal is for manufacturers of ultrasonic surgical aspirator devices with a general indication for use in…
New guidance1,2 from the US Food and Drug Administration (FDA) addresses the inclusion of a boxed warning and patient decision checklist in the product labelling for permanent, hysteroscopically-placed tubal implants intended for female sterilisation, as well as the content and…
Regulatory authority Article 3 of the Pharmaceutical Affairs Act (PAA)1 authorised the establishment of the Taiwan Food and Drug Administration (TFDA) in 2010 within the Ministry of Health and Welfare (MoHW) to administer ‘medicaments’. According to Article 4 of the…
India’s Central Drugs Standard Control Organization has extended1 the time period when medical device manufacturers may affix a sticker to a device label indicating the date of manufacture and the date of expiry, in accordance with the provisions of the…
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,…
Introduction India is one of the largest medical device markets globally and therefore needs a robust system for the regulation of medical devices. At present only a few medical devices in India are regulated as drugs under the Drugs and…
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…
Consultation has been held on a Draft Resolution for the mandatory inclusion of Unique Device Identification (UDI)/International Medical Device Regulators Forum (IMDRF) standard barcodes on traceability tags for cardiac stents, and hip and knee implants1. It is hoped that the…
A specific safety statement should be added to the product labelling of certain ultrasonic surgical aspirator devices according to a recent guidance document from the Food and Drug Administration1,2. Ultrasonic surgical aspirator devices are surgical tools intended to fragment, emulsify…
Manufacturers are being encouraged to consider child safety when designing X-ray imaging devices by a new final guidance document entitled, Pediatric Information for X-ray Imaging Device Premarket Notifications1,2. The guidance applies both to new devices and to modifications requiring the…
The Food and Drug Administration has published guidance1,2 to clarify its stance on manufacturers appropriately and responsibly sharing ‘patient-specific information’ with that patient at that patient’s request. The guidance provides information and recommendations to industry, healthcare providers and Agency staff…
Updated lists of standards harmonised under the Active Implantable Medical Device Directive (90/385/EEC), the Medical Device Directive (93/42/EEC) and the In Vitro Diagnostic Directive (98/79/EC) have been cited in the Official Journal in the form of three Commission Communications1-3. Of…
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…
The second edition of the guidance document on the requirements for the labelling of medical devices (MDA/GD/0026) has been released1. This updated document is intended to provide advice to manufacturers and Authorised Representatives on the content of medical device labelling.…
A new guidance document has been published by the Therapeutic Goods Administration to clarify the labelling requirements applicable to medical devices containing poisons1. Appendix A of Part 5 of the Poisons Standard lists products that are exempt from the requirements…
