Search
Swissmedic: Guidance for Requesting Product Certificates (Certificate of a Pharmaceutical Product)
Earlier today Switzerlands Swissmedic released an updated guidance document for "Requesting Product Certificates - Certificate of a...
Sharan Murugan
Mar 20, 20231 min read
USFDA Guidance: Electronic Systems, e-Records, & e-Signatures in clinical Investigations: Q&A
A draft guidance from the US Food and Drug Administration entitled "Electronic Systems, Electronic Records, and Electronic Signatures in...
Sharan Murugan
Mar 16, 20231 min read
Malaysia’s MDA : Guidance on Classification of Rehabilitation, Physiotherapy & Speech Therapy Device
Malaysia’s Ministry of Health Medical Device Authority (MDA) division recently updated its "Guidelines on Classification of...
Sharan Murugan
Mar 14, 20231 min read
EMA Guideline: Computerised Systems & Electronic Data in Clinical Trials
Recently (9 March 2023) the European Medicine agency released a "Guideline on Computerised Systems & Electronic Data in Clinical Trials"...
Sharan Murugan
Mar 11, 20231 min read
SAPHRA Guideline: Questions And Answers Licensing Of Medical Device Establishments
Recently this week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline On Questions And...
Sharan Murugan
Mar 8, 20231 min read
Finland's FIMEA: New/Updated (EU) MDCG Guidances to support Medical Device Operators
On 16 February 2023, the European Parliament approved the European Commission's proposal for amending the EU's Medical Device regulatory...
Sharan Murugan
Feb 25, 20231 min read
USFDA Med. Device: Guidance on Laser Products, Diagnostics, X-ray & Ultrasonic Diathermy Devices
The Center for Devices and Radiological Health released multiple guidances earlier today (21-February-2023), related to "Laser Products,...
Sharan Murugan
Feb 21, 20232 min read
Swiss Medic Guidance: Document on Formal requirements
Swissmedic released an updated guidance document on "Formal requirements" yesterday (15 February 2023). By publishing this document,...
Sharan Murugan
Feb 16, 20231 min read
SFDA Med.Dev: Guidance on National Diagnostic Reference Levels
The Saudi Food and Drug Authority (SFDA) released an updated guidance (7th February, 2023) on "National Diagnostic Reference Levels"....
Sharan Murugan
Feb 14, 20231 min read
EC-Med Dev.CG - Guidance on Classification Rules for In-vitro Diagnostic Medical Devices
The Medical Device Coordination Group (MDCG) released an updated guidance on "Classification Rules for In-vitro Diagnostic Medical...
Sharan Murugan
Feb 14, 20231 min read
Malaysia MD Guidance: How to Submit an Application for Registration of a Refurbished Medical Device
Malaysia’s Ministrt of Healths Medical Device Authority (MDA) division recently prepared a guideline "Guidelines for implementation of...
Sharan Murugan
Jan 19, 20231 min read
![USFDA Guidance: Photobiomodulation (PBM) Devices & Premarket Notification [510(k)] Submissions](https://static.wixstatic.com/media/nsplsh_4a67383974757642316951~mv2_d_12000_8000_s_4_2.jpg/v1/fill/w_1330,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/nsplsh_4a67383974757642316951~mv2_d_12000_8000_s_4_2.jpg)
![USFDA Guidance: Photobiomodulation (PBM) Devices & Premarket Notification [510(k)] Submissions](https://static.wixstatic.com/media/nsplsh_4a67383974757642316951~mv2_d_12000_8000_s_4_2.jpg/v1/fill/w_1596,h_1200,fp_0.50_0.50,q_90,enc_avif,quality_auto/nsplsh_4a67383974757642316951~mv2_d_12000_8000_s_4_2.jpg)
USFDA Guidance: Photobiomodulation (PBM) Devices & Premarket Notification [510(k)] Submissions
Recently (12-January-2023) the US Food and Drug Administration (FDA) relaeased draft guidance on "Photobiomodulation (PBM) Devices -...
Sharan Murugan
Jan 16, 20231 min read
Australia TGA: FAQ Importing & Supplying Medical Devices
Recently on 3rd January, 2023 Australia's Therapeutic Goods Administration (TGA) released a guidance on frequently asked questions...
Sharan Murugan
Jan 8, 20231 min read
Irelands HPRA's: Guide to Fees for Human Products
On 3rd January 2023, Irelands Health Products Regulatory Authority (HPRA) released an updated Guide related to "Fees for Human Products"....
Sharan Murugan
Jan 8, 20231 min read
SFDA MD Guidance: Requirements for Clinical Trials of Medical Device
Yesterday (26-December-2022) the South African Health Products Regulatory Authority (SAPHRA) released an updated "Requirements for...
Sharan Murugan
Dec 27, 20222 min read
UK MHRA: MD Guidance - Register Medical Devices to Place on the Market
Earlier today UK Medicines and Healthcare products Regulatory Agency released an updated guidance on "Register medical devices to place...
Sharan Murugan
Dec 6, 20221 min read
Malaysia’s MDA: Med Dev Guidance on Requirement for Labeling & Change Notification of Registered MD
Recently on 21st November, 2022 the Malaysian Medical Device Authority (MDA) updated its guidelines regarding the "Requirement for...
Sharan Murugan
Nov 27, 20221 min read
Singapore HSA MedDev: Regulatory Guidelines for Laboratory Developed Tests (LDTs)
On 22nd November, 2022 Singapore's Health Sciences Authority released the final Regulatory Guidelines for Laboratory Developed Tests...
Sharan Murugan
Nov 27, 20221 min read
Irelands HPRA's: Medical Device Guide to Clinical Investigations Carried Out in Ireland
On 18th November, 2022 Irelands Health Products Regulatory Authority (HPRA) released an updated Guide related to "Clinical Investigations...
Sharan Murugan
Nov 27, 20221 min read
USFDA MD Guidance: Referencing “Device” and “Counterfeit Device”
According to the US Food and Drug Administration's draft guidance, the definition of a device has been updated according to the...
Sharan Murugan
Nov 12, 20222 min read