INDiE Med Tech | Regulatory | Activity https://indiemedtech.com/groups/regulatory/ Activity feed for the group, Regulatory. Mon, 11 May 2026 21:48:45 -0400 https://buddypress.org/?v=2.14.0 en-US 30 hourly 2 ee6ed3e54d6179c90ed2c5f66b499b0f Dawn joined the group Regulatory https://indiemedtech.com/news-feed/p/830/ Mon, 11 May 2026 13:32:27 -0400 0 8331da25f0bf4ef25a32ac5d6292528a Holly started the discussion Manufacturing and Import Authorization - UK in the forum Regulatory https://indiemedtech.com/groups/regulatory/forum/topic-discussion/manufacturing-and-import-authorization-uk/ Tue, 21 Apr 2026 13:28:00 -0400 Manufacturing and Import Authorization - UK

Hi everyone – I have a combo product question for ya. Does anyone know what all is required for a UK manufacturing and import authorization of investigational medicinal products if the manufacturer is located in the US? The guidance is a bit confusing as it seems to only focus on manufacturers located in “approved countries” which, as far as I…

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]]> 3744d601dd7e9774352339eb51d0e450 Joe replied to the discussion eMDR Gateway set up in the forum Regulatory https://indiemedtech.com/groups/regulatory/forum/topic-discussion/emdr-gateway-set-up/#post-4227 Sat, 07 Mar 2026 00:36:47 -0500 Reply to eMDR Gateway set up

Yeah hey Jude, seems like these guys have you in good shape, but there is an eSubmitter software you can download and after that you should he able to directly access the gateway from your desktop. But once inside, you can select the option for FDA form 3500A.

If you also need help with assigning any of the codes associated with any MDR, let…

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]]> 7a8643622a85aeb4045691a48192ab59 Jeff replied to the discussion eMDR Gateway set up in the forum Regulatory https://indiemedtech.com/groups/regulatory/forum/topic-discussion/emdr-gateway-set-up/#post-4222 Tue, 03 Mar 2026 18:23:59 -0500 Reply to eMDR Gateway set up

Hi Jude, happy to help as well. Here is a link to the FDA’s page for the ESG NextGen:

https://www.fda.gov/industry/electronic-submissions-gateway-next-generation-esg-nextgen/getting-started-esg-nextgen

If you have additional questions or want further pointers, please reach out directly.

fda.gov

Getting Started with ESG NextGen

Getting Started with ESG NextGen

]]> f9bf010a6cd72d685e4ee860ef942262 Melissa replied to the discussion eMDR Gateway set up in the forum Regulatory https://indiemedtech.com/groups/regulatory/forum/topic-discussion/emdr-gateway-set-up/#post-4220 Tue, 03 Mar 2026 18:13:59 -0500 Reply to eMDR Gateway set up

Hi Jude. Yes, I can help you out – let’s connect directly!

]]> 4ce7d224fbe7076d826a194524ed497a Jude started the discussion eMDR Gateway set up in the forum Regulatory https://indiemedtech.com/groups/regulatory/forum/topic-discussion/emdr-gateway-set-up/ Tue, 03 Mar 2026 18:08:57 -0500 eMDR Gateway set up

My client has the need to set up and begin submitting MDR’s. The guidance mentions an ESG Next Gen gateway. I have never set this up. Does anyone have experience with this and can provide some pointers.

]]> 114c23b87f0270ea8c59525504130bd2 Dulciana joined the group Regulatory https://indiemedtech.com/news-feed/p/790/ Mon, 02 Mar 2026 21:13:24 -0500 0 e30152da5b3f4c86752f0494d45c0258 Ash replied to the discussion IVDR Metrological Traceability in the forum Regulatory https://indiemedtech.com/groups/regulatory/forum/topic-discussion/ivdr-metrological-traceability/#post-4211 Wed, 04 Feb 2026 19:21:51 -0500 Reply to IVDR Metrological Traceability

Hey Holly, sorry, I meant the metrological traceability section. No screen shot, we don’t have any verbiage for it yet.

]]> 0665cc8599d6c8fe5ee7dd8cf492f0e9 Ash replied to the discussion IVDR Metrological Traceability in the forum Regulatory https://indiemedtech.com/groups/regulatory/forum/topic-discussion/ivdr-metrological-traceability/#post-4210 Wed, 04 Feb 2026 19:20:52 -0500 Reply to IVDR Metrological Traceability

It is a standalone control used to verify calibration of clinical lab equipment. The NB seems to want to see metrological traceability back to the original control material or some statement to that effect in the IFU.

]]> 047c529dd7b228573c01cfa1dad84a6b Holly replied to the discussion IVDR Metrological Traceability in the forum Regulatory https://indiemedtech.com/groups/regulatory/forum/topic-discussion/ivdr-metrological-traceability/#post-4207 Wed, 04 Feb 2026 14:56:44 -0500 Reply to IVDR Metrological Traceability

Hi Ash, also not sure if you intended to include any type of screenshot or anything but what specifically in the IFU were they pushing back on? Thanks!

]]> 289c960e13ffd9bf83746140032609b9 Jude replied to the discussion IVDR Metrological Traceability in the forum Regulatory https://indiemedtech.com/groups/regulatory/forum/topic-discussion/ivdr-metrological-traceability/#post-4206 Wed, 04 Feb 2026 14:54:13 -0500 Reply to IVDR Metrological Traceability

Hi Ash can you be more specific as to what on the Medical Device requires Metrological Traceability ?

]]> a666f443be83aa0285a22a45f61b09f6 Ash started the discussion IVDR Metrological Traceability in the forum Regulatory https://indiemedtech.com/groups/regulatory/forum/topic-discussion/ivdr-metrological-traceability/ Wed, 04 Feb 2026 14:40:48 -0500 IVDR Metrological Traceability

Hey Friends,

Has anyone ever had a product with applicable metrological traceability? I am working with a client and we are getting push back from the NB re: this section of our IFU. Any ideas?

]]> 946e583f299b7c04f71bce0a777d2f52 Ash joined the group Regulatory https://indiemedtech.com/news-feed/p/763/ Wed, 04 Feb 2026 14:38:41 -0500 0 b6e80d14f23a6b45adf92ce77e0f471b Karandeep joined the group Regulatory https://indiemedtech.com/news-feed/p/746/ Tue, 03 Feb 2026 13:24:40 -0500 0 293b0c91a0f584c7310bd5e03f89a9f3 Jeff joined the group Regulatory https://indiemedtech.com/news-feed/p/727/ Fri, 30 Jan 2026 14:56:10 -0500 0 020a04d3dffde17941f849acc42ac98e Rebecca joined the group Regulatory https://indiemedtech.com/news-feed/p/710/ Thu, 29 Jan 2026 20:33:46 -0500 0 66e088b56b050362ab53b5b075633a0f Joe joined the group Regulatory https://indiemedtech.com/news-feed/p/701/ Thu, 29 Jan 2026 17:25:45 -0500 0 b873de8775d83c2b4136f58ef53e12b5 Cullom joined the group Regulatory https://indiemedtech.com/news-feed/p/641/ Tue, 06 Jan 2026 17:14:05 -0500 0 4a7d8b3795e3cbe2b0c3c79a2788e3c2 Greg joined the group Regulatory https://indiemedtech.com/news-feed/p/632/ Mon, 29 Dec 2025 22:04:53 -0500 0 49f7943bdc401eb1cb26f5a7512f49aa Niki joined the group Regulatory https://indiemedtech.com/news-feed/p/613/ Thu, 18 Dec 2025 17:03:47 -0500 0 71e5d7d6d633bdb007f48275b6f2f9fa Catherine joined the group Regulatory https://indiemedtech.com/news-feed/p/599/ Tue, 16 Dec 2025 23:10:21 -0500 0 a9f4233ad26d75cbffa1fe12b8bff2b0 Holly started the discussion BDR or Pre-Sub? in the forum Regulatory https://indiemedtech.com/groups/regulatory/forum/topic-discussion/bdr-or-pre-sub/ Mon, 15 Dec 2025 11:46:17 -0500 BDR or Pre-Sub?

Hi everyone, I have a client where I am trying to decide whether to recommend a BDDR or a pre-submission first. They will need another pre-submission eventually as their submission requires a GLP animal study and potentially another clinical study (and in their last pre-sub the FDA asked them to present their substantial equivalence table so…

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]]> 8199e2be44405378c34051e1832aa1c8 Holly posted an update in the group Regulatory: Does anyone know why we can no longer see 510k summaries […] https://indiemedtech.com/news-feed/p/588/ Mon, 08 Dec 2025 19:02:39 -0500 Does anyone know why we can no longer see 510k summaries in the 510k database? I am even trying old ones that I know I have pulled recently and they are all missing…

]]> 2 3666635a449fb4fa7f216d80e124595e Grace joined the group Regulatory https://indiemedtech.com/news-feed/p/547/ Wed, 12 Nov 2025 15:51:54 -0500 0 2087346b6ec918db6c5802cee784bf1b Joe joined the group Regulatory https://indiemedtech.com/news-feed/p/530/ Thu, 06 Nov 2025 22:48:10 -0500 0 df5762e7c2016442abee91def1408e67 Holly replied to the discussion Malaysia is now a MDSAP member in the forum Regulatory https://indiemedtech.com/groups/regulatory/forum/topic-discussion/malaysia-is-now-a-mdsap-member/#post-3756 Tue, 23 Sep 2025 19:33:05 -0400 Reply to Malaysia is now a MDSAP member

Here ya go: https://portal.mda.gov.my/index.php/announcement/1636-malaysia-is-now-mdsap-medical-device-single-audit-program-mdsap-member

portal.mda.gov.my

MALAYSIA IS NOW A MEMBER OF MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP)

Official portal of MDA Malaysia. Regulatory information, device registration & safety under Medical Device Acts 737 & 738

]]> d1028309202afdef0a49688bcc4e92b6 Jude started the discussion Malaysia is now a MDSAP member in the forum Regulatory https://indiemedtech.com/groups/regulatory/forum/topic-discussion/malaysia-is-now-a-mdsap-member/ Tue, 23 Sep 2025 19:11:35 -0400 Malaysia is now a MDSAP member

Malaysia is now a MDSAP member – unable to post the link to the MDSAP site

]]> 150a46b835c063575aae587fbed95d9a Kimberly joined the group Regulatory https://indiemedtech.com/news-feed/p/436/ Mon, 22 Sep 2025 20:15:54 -0400 0 dcada1899d8649b44c29f1c844889cf7 Jared joined the group Regulatory https://indiemedtech.com/news-feed/p/421/ Mon, 15 Sep 2025 15:53:30 -0400 0 757a9237edf2282c7de559874e24feb8 Purvi joined the group Regulatory https://indiemedtech.com/news-feed/p/419/ Sun, 14 Sep 2025 01:46:49 -0400 0 b14d8afd821139424dc96c504e6aad40 Daria joined the group Regulatory https://indiemedtech.com/news-feed/p/402/ Tue, 09 Sep 2025 23:21:05 -0400 0 93846f12ac4ebaa34dce9401d5466615 Dongeun joined the group Regulatory https://indiemedtech.com/news-feed/p/390/ Sat, 06 Sep 2025 01:56:27 -0400 0 15067f4187080f729733e01a830b6342 Jude joined the group Regulatory https://indiemedtech.com/news-feed/p/385/ Fri, 05 Sep 2025 17:49:03 -0400 0 47a960fd026e207451b93fa3aee1f25d Pamela joined the group Regulatory https://indiemedtech.com/news-feed/p/380/ Fri, 05 Sep 2025 12:00:41 -0400 0 c9b8851d6087ba41d6b123e704ec9dc4 Chad joined the group Regulatory https://indiemedtech.com/news-feed/p/379/ Fri, 05 Sep 2025 11:51:28 -0400 0 60488a9c59629ce2e42955c66e21b057 Melissa joined the group Regulatory https://indiemedtech.com/news-feed/p/373/ Fri, 05 Sep 2025 10:10:36 -0400 0 5d2cd41da04debb5ce6f098cd8eadbaf Amie joined the group Regulatory https://indiemedtech.com/news-feed/p/369/ Thu, 04 Sep 2025 21:35:14 -0400 0 ef8469ea2b2dcf1d19fcda73e5e62761 Felicia joined the group Regulatory https://indiemedtech.com/news-feed/p/368/ Thu, 04 Sep 2025 21:13:33 -0400 0 c51be84efddc2db3f912149039333314 Jarrell joined the group Regulatory https://indiemedtech.com/news-feed/p/366/ Thu, 04 Sep 2025 21:10:12 -0400 0 b608ba64fd6328b419969d66624c4224 Holly created the group Regulatory https://indiemedtech.com/news-feed/p/365/ Thu, 04 Sep 2025 21:08:43 -0400 0