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USFDA MD Guidance: Cybersecurity-Refuse to Accept Policy for Cyber Devices & Related Systems

Earlier today (30 March 2023) USFDA's Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research...

Sharan Murugan

Mar 30, 20232 min read

USFDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices

Today (27 March 2023) USFDA's Center for Devices and Radiological Health released final guidance on "General Considerations for Animal...

Sharan Murugan

Mar 27, 20232 min read

UK MHRA: Guidance on Register Medical Devices to place on the Market

Earlier today (27 March 2023) UK's Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance on "Register...

Sharan Murugan

Mar 27, 20231 min read

USFDA MD Guidance: Transition Plan for M.D Issued Emergency Use Authorizations Related to COVID-19

On 24 March 2023, USFDA's Center for Devices and Radiological Health released two final guidances on "Transition Plan for Medical Devices...

Sharan Murugan

Mar 24, 20231 min read

UK MHRA: MD Guidance on Crafting an Intended Purpose in the Context of SaMD

Earlier today (22 March 2023) UK Medicines and Healthcare products Regulatory Agency released updated guidance on "Crafting an intended...

Sharan Murugan

Mar 22, 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A draft guidance from the US Food and Drug Administration entitled "Electronic Systems, Electronic Records, and Electronic Signatures in...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

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

USFDA ME Guidance: Voluntary Malfunction Summary Reporting (VMSR) Program

Recently on 12-December-2022 USFDA's Center for Biologics Evaluation and Research and Center for Devices and Radiological Health released...

Sharan Murugan

Dec 14, 20221 min read