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, …

Custom Duty Hike To Domestic Medical Device MakersRead More »

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 …

UDI Guidance Published by European Regulators | Medical DevicesRead More »

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 …

Updates On Borderline Device Classification Manual By European CommissionRead More »

The Food and Drugs Authority has cautioned members of the Ghana Federation for Traditional Herbal Medicine Practitioners Association (GAFTRAM) against the use of unregistered medical devices, whether imported or locally manufactured.Mr Josep.h Yaw-Bernie Bennie, the Head of Medical Devices Department of the Authority, explained that medical devices played critical roles in quality health care delivery, hence the need for …

FDA cautions against the use of unregistered medical devicesRead More »

Food and Drug Administration(FDA) Commissioner Dr. Scott Gottlieb said Thursday that the agency is considering regulating digital tools that are used to encourage prescription medication adherence, potentially as part of a drug review process. Pharmaceutical companies have partnered with digital health product developers to create tools that can be packaged around pharmaceutical use and encourage greater adherence, …

FDA看起来调节数字药物产品|数码网络tal HealthRead More »

指导草案佛r 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 submitter …

Demonstrating Substantial Equivalence through Performance Criteria | Abbreviated 510(k)Read More »

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 …

FDA unveils action plan to improve medical device safetyRead More »

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. …

Validation of Next Generation Sequencing | In Vitro Diagnostics (IVDs)Read More »