The formulation of the law aimed at ensuring road safety, averting accidents and restoring discipline to the roads. The RTA is a big breakthrough in extending the legislative landscape on road safety, replacing the Motor Vehicles Ordinance, 1983. But it is frustrating as the law is yet to commence in full even after elapse of over two and half years. The government is in a dilemma over balancing the interests of passengers and that of vehicle owners with their workers. The government is apparently more submissive to transport owners and workers than those who use such vehicles and are victim is of reckless driving and risky overtaking along with exceeding the speed limit. Bowing to the demands of transport owners and workers soon after the enforcement of the RTA on 1 November 2019, the government withheld certain provisions. Even before enforcement of the RTA, the government initiated a review committee led by home minister Asaduzzaman Khan to amend the law and to woo the workers. Two laws – the Digital Security Act (DSA) and the RTA – were assented by the president on 8 October 2018 but the DSA was enforced with immediate effect. However, RTA is facing delays in full enforcement. Apart from generating of mass awareness through involvement of all stakeholders to stimulate road safety in Bangladesh, the globally accepted 3E approach- education, engineering and enforcement of law – can be a way out More surprisingly, the RTA is now in the process of amendment, aiming at lessening the gravity of penalty for the wrongdoers of road accidents. According to a report of Prothom Alo on 29 July, the review committee recommended modifying several provisions of the law with a purpose of lessening severity of the penalty. Previously, in line with Section 105, the RTA had a maximum five-year of imprisonment or fine of Tk 500,000 or both for perpetrators of road accidental deaths but the recommended change is likely to reduce fine to Tk 300,000. Amendment of Section 98 will provide leeway to more recklessness of drivers, conductors or even helpers as the proposal is finalised to delete the word overloading and replacement of the phrase speed limit with speeding, paving the way for vagueness. The other provisions envisaged in the section with three-year of imprisonment or fine of Tk 300,000 or both will remain unchanged against perpetrating drivers, conductors or helpers for accidents owing to exceeding the speed limit, risky overtaking and overloading. Though, the offences under sections 84, 98 and 105 are non-bailable, the committee with the touch of the rule of laxity has recommended non-bailable crimes as bailable ones raising question of credibility of the RTA. Recommendation is also made to settling disputes under section 98 through mutual compromise. Alteration of the law will extend more immunity and indemnity to the transgressors, despite regular prevalence of accidental deaths and fatal injuries on roads, across the country. The RTA enforcing body Bangladesh Road Transport Authority (BRTA)’s report as of February 2017 reveals 2.9 million registered vehicles in the country with only 1.9 million registered drivers while the rest are the ghost drivers without driving licence or training.https://en.prothomalo.com/opinion/road-safety-v-road-transport-act-2018
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Any evaluations following older ISO standards require a gap analysis and, if needed, supporting justifications. While performing new testing procedures is not technically required to satisfy the requirements of all new standards, complying to EU MDR may prompt additional evaluations to fill gaps in data or meet testing parameters. While NBs have broad acceptance of the ISO 10993 standards, the intricacies of their acceptance still require attention to small variances. These NBs use ISO 10993 as a baseline, where others have a more selective means of acceptance. As of February 2020, the Japanese MHLW wholly recommends using ISO 10993 standards and further expands upon them – holding biocompatibility tests to a high standard. Officials require separate extraction strategies for sensitisation and genetic toxicity testing; an attempt to deliver sufficient extractable chemicals to represent the whole device or to deliver more extractable chemicals that could be administered by standard extraction procedures. The U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) do not recognise all current ISO 10993 standards. When submitting under either jurisdiction, manufacturers should dedicate time to understanding the acceptance criteria of each part to the standard. With submissions in the U.S., many parts of ISO 10993 are only partially accepted, meaning manufacturers should review the agency’s latest guidance documents and database of recognised consensus standards. Devices containing novel materials will likely be subjected to greater scrutiny than those containing well-established materials, and additional testing may be necessary. The NMPA does not universally accept current versions of ISO standards and may prefer conformance to previous versions. It is essential to reference the Chinese standards and the equivalent versions of the ISO standards with every submission. Still, subject to an individual reviewer’s discretion, risk-based evaluations are accepted based on the reviewer’s perspective. Additionally, the regulatory body evaluates medical devices with CE mark or 510(k) clearance using alternative procedures. Thus, device submissions already holding EU and U.S. clearance can streamline the review process by taking alternative regulatory pathways when submitting a device to the NMPA. Whichever governing body a manufacturer plans to submit to, they should review their submissions closely. The acceptance of 10993 varies from regulator to regulator and standards continue to evolve. With each new version of the ISO 10993 series of standards, manufacturers can begin to see where regulators hope to push biological evaluations in the future. Short-term perspectives might focus on the additional test methods and evaluation procedures, but in the long-term, experts are aiming to gain a better understanding of each specific device and tailor evaluations accordingly. Guidance outlined in ISO 10993-1 and EU MDR increased the importance of materials characterisation, physical and/or chemical information, and risk assessments. Regulators expect detailed chemical information supporting biocompatibility test plans and additional testing like extractables and leachables (E/L) studies to identify all chemicals of potential toxicologic concern. Recent on the main page updates to ISO 10993-18 include advanced chemical characterisation requirements and the exposure dose estimation. First, manufacturers must submit multiple replicates during chemical characterisation testing. Then during study development, toxicological data and exposure assumptions must inform chemistry study design and execution.https://www.med-technews.com/medtech-insights/medtech-regulatory-insights/interpreting-iso-standards-to-streamline-testing-and-submiss/