It’s cheaper now with IMR

By CHARMAINE LIY

The Medical Device Authority of Malaysia has decided to recognise the Institute for Medical Research (IMR) as one of the institutions that is capable of providing the report or data of clinical evidence or performance evaluation for the purpose of conformity assessment by the Conformity Assessment Body.

The recognition came in a recent circular prepared by the Medical Device Authority (MDA) to facilitate the stakeholder and industry in the implementation of Medical Device Act (Act 737) Medical Device Act (Act 737) and the regulations under it.

The Circular Letter, among others, mentioned that Regulation 4(1) of Medical Device Regulation 2012 requires that all medical devices should be subjected to conformity assessment to demonstrate its conformity in line with the requirement of the latest medical device law in Malaysia.

Under Regulation 4(2), manufacturers of medical devices are required to collect all evidence of conformity, appoint a conformity assessment body to conduct assessment on the conformity.

One of the conformity assessment is on technical documentation. Prior to this circular, there was no local body in terms of assessment on this aspect. The move to recognise IMR is aimed at reducing the costs and time for manufacturers as the time and costs of conducting overseas assessment is rather high.

The Medical Device Regulations 2012 was established to help regulate manufacturers of medical devices to be up to standard – albeit set by the Medical Device Authority (MDA), a body under the Health Ministry tasked with supervising the country’s Medical devices are defined as any medical technology, supplies and equipment which encompass instrument used for diagnosis, prevention, monitoring and treatment of illness or handicap but exclude drugs.They would be categorised depending on the risk level and intended use.

Under the regulations, those producing or importing these items must register the products with the MDA.

Malaysian manufacturers of medical devices can either register on their own or do it through a regulatory consultant like us. Just click(https://ttmedical.com.my/malaysia-medical-device-license-application/)

Foreign manufacturers on the other hand would need to be registered through a Local Authorised Representative like us. Please click (https://ttmedical.com.my/malaysia-medical-device-license-application/)

According to experts, the regulated standards under the Medical Device Regulations would help Malaysia be recognised as a reliable producer of medical devices in the global market as well as attract foreign direct investment.

According to a World Health Organisation report, an authorised officer may investigate any potential violations of the Medical Devices Act 2012 and if found guilty, the manufacturer may be liable to a jail term or fine.

18 Comments
  • 720p izle
    Posted at 10:07h, 10 December Reply

    Loving the info on this internet site , you have done outstanding job on the articles. Kayla Terence Knowland

  • krystina bragg
    Posted at 08:39h, 01 January Reply

    I read a great article with pleasure, I hope it will continue

  • hong mierow
    Posted at 06:53h, 03 January Reply

    I like and follow your site, thanks

  • randal bonifay
    Posted at 15:56h, 04 January Reply

    Very informative blog article.Much thanks again. Fantastic.

  • citroen relay replacement key cost
    Posted at 09:53h, 05 January Reply

    Woh I enjoy your posts, saved to my bookmarks!

  • leisa friederich
    Posted at 16:23h, 06 January Reply

    Greate article. Keep writing such kind of info on your blog.

  • jak leczyć trądzik młodzieńczy
    Posted at 02:46h, 07 January Reply

    Jak potrzebujesz jak leczyć trądzik młodzieńczy to sprawdź mojego bloga. Najlepsze suplementy na trądzik oraz sprawdzone leki.

  • erectile dysfunction pills
    Posted at 09:19h, 07 January Reply

    I am also writing to make you know what a incredible encounter my friend’s girl gained reading through your web page. She learned plenty of pieces, which include what it’s like to possess an amazing helping mood to let other folks smoothly know just exactly several multifaceted subject matter. You truly exceeded our own expectations. Thank you for offering these necessary, safe, explanatory and even fun tips about this topic to Julie.

  • buy cbd oil
    Posted at 10:00h, 07 January Reply

    I needed to post you that little bit of observation to say thanks once again for your personal marvelous principles you’ve featured in this article. It is quite seriously generous of people like you to give openly just what many individuals might have marketed as an e book to generate some dough for themselves, most notably seeing that you might have tried it in case you desired. Those strategies in addition worked to become good way to know that some people have the identical keenness really like my personal own to realize much more when considering this matter. I believe there are several more pleasant sessions up front for people who read through your site.

  • viagra cost
    Posted at 02:18h, 08 January Reply

    Thank you for each of your hard work on this web page. My aunt really likes going through investigations and it’s really obvious why. Most of us learn all of the lively method you offer practical strategies through this web site and even increase participation from some other people on the issue so our favorite girl is in fact learning a lot of things. Take advantage of the rest of the year. You are always doing a really great job.

  • order aripiprazole
    Posted at 10:31h, 08 January Reply

    I simply wished to thank you very much yet again. I do not know what I would have tried without these techniques shared by you regarding this subject matter. It was before the scary scenario in my position, nevertheless taking note of this specialized tactic you solved the issue took me to weep with happiness. Now i’m thankful for your support and thus trust you really know what an amazing job you were putting in training the mediocre ones via your webpage. Most probably you haven’t met any of us.

  • purchase ARIPIPRAZOLE
    Posted at 11:09h, 08 January Reply

    I am only writing to make you understand what a remarkable experience our princess undergone viewing your webblog. She picked up such a lot of things, with the inclusion of what it is like to possess an ideal teaching spirit to make the mediocre ones without difficulty master specified tortuous topics. You undoubtedly surpassed readers’ expected results. Thanks for rendering those useful, trustworthy, revealing as well as unique tips on your topic to Sandra.

  • escitalopram generic
    Posted at 20:14h, 08 January Reply

    I am glad for writing to make you know what a nice encounter my wife’s girl had studying your web site. She mastered several pieces, which include what it’s like to possess an awesome helping nature to let men and women really easily have an understanding of selected hard to do subject areas. You really exceeded our own expectations. Many thanks for imparting the interesting, safe, explanatory and even easy thoughts on the topic to Janet.

  • imipramine cost
    Posted at 17:56h, 09 January Reply

    My wife and i were very thrilled when Raymond managed to round up his web research with the precious recommendations he was given while using the weblog. It is now and again perplexing to simply possibly be releasing tricks which usually the rest might have been trying to sell. We really understand we now have you to thank for this. Those illustrations you made, the straightforward website navigation, the relationships your site make it possible to promote – it is mostly wonderful, and it is making our son in addition to us understand this topic is thrilling, which is certainly wonderfully vital. Thanks for the whole thing!

  • gerardo tobert
    Posted at 18:49h, 09 January Reply

    I get very useful information on your page, I feel lucky

  • doxepin pills
    Posted at 21:56h, 09 January Reply

    I simply wished to thank you very much yet again. I do not know what I would have used without those tricks shown by you relating to this topic. This has been the traumatic situation in my view, nevertheless viewing your well-written way you treated the issue took me to weep with joy. Now i am thankful for your work as well as wish you recognize what an amazing job your are undertaking training the rest with the aid of your websites. Probably you haven’t met any of us.

  • haber
    Posted at 14:22h, 21 January Reply

    Thanks so much for the blog post.Thanks Again. Great.

  • Felicity
    Posted at 13:07h, 23 January Reply

    I will recommend your beautiful post site to my friends

Post A Comment