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Draft Guidance for Industry, Food and Drug Administration Document issued on April 12, 2018.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

Guidance for Stakeholders and Food and Drug Administration Staff Document issued on April 13, 2018. The field of genomic testing is dynamic, building off of increasing amounts of data and a rapidly evolving technology base. Next-Generation Sequencing offers multiple approaches for the investigation of the human genome, including sequencing of the whole genome, exome, and transcriptome.

HealthCanada is establishing a new division within the Therapeutic Products Directorate’s Medical Devices Bureau to allow for a more targeted premarket review of digital health technologies, to adapt to rapidly changing digital health technologies, and to respond to fast innovation cycles. Digital health technologies can include stand-alone software applications as well as integrated hardware and software systems which