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A database of fragrance chemicals found in children's products reveals information gaps
According to the Indian researchers who compiled the chemicals’ database, there is a need for better risk assessment and regulation of fragrance substances in children's products.
Due to the collaboration between two Research Institutes: t
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Resolutions for Brazilian Medical Devices
According to notifications from World Trade Organization (WTO), several resolutions for medical devices are proposed to enter into force with the earliest start being on May 2, 2022, by the Brazilian Health Regulatory Agency. Earlier in March 2022, B
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India releases a proposal of new E-waste management regulations
On May 20, 2022, the Indian Ministry of Environment, Forest, and Climate Change released a new regulation draft that will replace the current E-Waste (Management) Rules, 2016. In addition to information technology and telecommunications equipment and
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How to prepare for the EU Medical Devices Regulation MDR and In Vitro Diagnostic Medical Devices Regulation IVDR - Mandarin
*Disclaimer: This webinar will be given in Mandarin
The new European Medical Device Regulation (MDR, EU 2017/745) replaced the Medical Devices Directive (MDD, 93/42/EEC) and Active Implantable Medical Devices Directive (AIMDD, 90/385/EEC) implemen
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Legal Basis and Authorities
The European Medical Devices Regulation (MDR) replaced the previous Medical Device Directive (MEDDEV), which was lagging the current state of the art. The MDR will be:
Introduced progressively
Updated regularly by means of Implementi
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Who can Register?
A notified body is an organization designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislat
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Product Registration
Before placing a device, other than a custom-made device, on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 27(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and
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Toxicological Information
The FDA's toxicological evaluation is based on a tiered approach and is consistent with the general principle that increased exposure results in increased potential health risks; however, the inherent toxicity of a structural/functional class of
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