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The FDA issued Medical Device Accessories –Guidance for Industry and Food and Drug Administration Staff, which applies to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) for combination products. The #guidance document offers welcomed clarity on the role of an “accessory” and its regulatory relationship to its parent device. As always, guidance documents are […]

The EU’s General Data Protection Regulation(GDPR) will go into full effect on May 25, 2018.  While most of the GDPR affects the back end of medical device data handling, the Cloud, Databases, and transportation of data, some of the GDPR affects software on medical devices themselves.The basic concept is that your patient’s data is no longer yours to process at

The Australian Dental Industry Association (ADIA) has this week reported that small businesses will be hit particularly hard by a new tax proposed by the nation’s regulator of dental products and other medical devices, the Therapeutic Goods Administration (TGA). Businesses would be required to pay the new tax to supply new and innovative products lawfully in the medical and dental

In March 2018, The Pharma Department proposed new procurement guidelines for at least 50% of some types of devices to come from Indian companies. India has proposed regulating the proportion of locally made and imported medical devices procurement by public programs. The Department of Pharmaceutical has proposed that the sourced components have to contribute 25-50% cost of medical devices procured by

The ISO 13485 Standard Is an Effective Solution to Meet the Comprehensive Requirements for a QMS ISO 13485 is a standalone QMS standard based on the internationally established and acknowledged ISO 9000 quality management standard series. It applies the ISO 9000 process-based approach to a regulated medical device manufacturing environment. ISO 13485 was created to

The government needs to increase the basic customs duty on medical devices in the range of 5-15 percent to promote domestic manufacturing, Association of Indian Medical Device Industry (AiMeD) said today. The current slab is 0-7.5 percent, it said.It stated that the medical devices sector expects an extension of inverted duty tariff rationalisation to medical electronics and diagnostics. Medical devices include any instrument, apparatus, appliance,

Let us have a brief intro on what is UDI?, In short, the Unique Device Identification (UDI) consists of a code on the label of a device. The first part of this code is unique and linked to all devices of that specific type; the second part of the code is linked to the homogeneous production of devices

Manual on Borderline and classification in the community regulatory framework for medical devices. Version 1.19(04-2018) This manual shall only serve as “tool” for the case-by-case application of Community legislation by the member-states. It is for the national competent authorities and national courts to assess on a case-by-case basis. Borderline Device Classification cases are considered to

Draft Guidance for Industry, Food and Drug Administration Document issued on April 12, 2018. This guidance provides FDA’s current thinking on expanding the use of the Abbreviated 510k program for demonstrating substantial equivalence for premarket notification (510(k)) submissions. The intent of the guidance is to describe an optional pathway for certain, well-understood device types, where a

For medical device safety the US Food and Drug Administration has unveiled a new action plan to ensure the safety of medical devices and patient protection while also driving innovation. A medical device is any product used for diagnose, cure, treat, a condition, or to prevent a disease, so it is necessary to use safety