tag:blogger.com,1999:blog-6125857314165645951.post1741104397990283379..comments2024-02-10T00:21:20.822-08:00Comments on The Gigamole Diaries: HSA and the regulation of medical devices - an exercise in agenda setting?gigamolehttp://www.blogger.com/profile/18328852130774608540noreply@blogger.comBlogger3125tag:blogger.com,1999:blog-6125857314165645951.post-11253335904774130952012-04-17T04:09:22.236-07:002012-04-17T04:09:22.236-07:00Quite clearly this process had been mismanaged ove...Quite clearly this process had been mismanaged over the last decade. These regulations could have been phased in in stages. Staffing could have been better planned for and allocated to clear the backlog.<br /><br />On the other hand, distributors and suppliers should also not act dumb, as if these sprang up overnight. They knew it was coming and should have planned for it. <br /><br />It is both an irony and tragedy, especially if these regulations fail to be implemented properly. It is really in no ones interest to keep the status quo where all kinds of thingys can get stuck into the body without first being evaluated for quality and safety.<br /><br />Consider how unsafe patients would be if drug use was not subject to regulatory oversight.<br /><br />Methinks Salma Khalik is being a tad irresponsible in fanning the fires here.gigamolehttps://www.blogger.com/profile/18328852130774608540noreply@blogger.comtag:blogger.com,1999:blog-6125857314165645951.post-46579861736349556002012-04-15T04:42:25.382-07:002012-04-15T04:42:25.382-07:00It is an irony that in the us, eu and Australia th...It is an irony that in the us, eu and Australia the public are pushing for tighter medical device regulations but in Singapore the converse is happening. <br />It is true that access to good devices has to be prompt but verification has to be performed and the hands of the regulators should not be tied. <br />We do not need a Lehman brothers style medical device issue to erupt. I would expect industry to always be unhappy about regulations but I doubt all doctors are anti regulationsAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-6125857314165645951.post-47592480142260274652012-04-15T00:38:29.610-07:002012-04-15T00:38:29.610-07:00The HSA has itself to blame for the negative publi...The HSA has itself to blame for the negative publicity; in my view, it had been quite sloppy in implementing the regulatory changes. <br /><br />The senior management should have taken stock of the large backlog of applications submitted before May 2010 (568) and 4,000 in 2nd half, 2011 as well as 450 just in the first few months of 2012. This should have alerted it to recognize its inability to cope with the implementation of the regulatory changes. It should also have stayed close to the ground and listened to the concerns raised (e.g. from docs and distributors/suppliers) sooner and made changes to the implementation, at least in the shorter term, to reduce delays while it tries to beef up its team to clear the applications. <br /><br />Btw, the same CEO talked about the regulatory changes since 2007, so there has been almost 5 years lead time for the HSA to put its act together.Anonymousnoreply@blogger.com