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Australia TGA: Regulatory Guidelines for Medical Devices (ARGMD)
The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance on 19-August-2022, which provides information...
Sharan Murugan
Aug 21, 20221 min read
USFDA's Guidance on Hearing Aid Devices, Replacement Reagent & Contact Lens Care Products
Today USFDA's Center for Devices and Radiological Health updated multiple guidances such as "Regulatory Requirements for Hearing Aid...
Sharan Murugan
Aug 17, 20222 min read
USFDA's New WebPage: For Complex Generics
Friday the USFDA agency published a new web page to share the most recent FDA actions and activities related to complex generics, which...
Sharan Murugan
Aug 7, 20221 min read
USFDA Guidance: Changes to Disposable Manufacturing Materials, Clinical Pharmacology Considerations
Multiple guidances were updated and released by the USFDA last week and had some important updates related to Drugs, Biologics, and...
Sharan Murugan
Jul 31, 20222 min read
UK updated Guidance: Register Medical Devices to Place on the Market
Earlier this Thursday the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on how to register your medical...
Sharan Murugan
Jul 31, 20221 min read
India CDSCO Guidance: 3 IVD Draft Guidances for Consultation
Recently the Indian Central Drugs Standard Control Organization (CDSCO) released three draft guidance documents, where the In vitro...
Sharan Murugan
Jul 27, 20221 min read
EMA: Plan for Digital Hub for the European Medicines Regulatory Network
A technology capability investment plan has been published by the European Medicines Agency (EMA), which outlines how it plans to invest...
Sharan Murugan
Jul 26, 20221 min read
USFDA's Draft Guidance: Conducting Remote Regulatory Assessments Q&A
On 22-July 2022, USFDA released multiple guidance among them one is "Conducting Remote Regulatory Assessments Questions and Answers"....
Sharan Murugan
Jul 23, 20221 min read
Ireland's HPRA -Guide to Performance Studies Conducted in Ireland
On 15-June-22, the HPRA released a guide on how to Performance Studies Conducted in Ireland. The term ‘performance study’ (PS) is defined...
Sharan Murugan
Jun 18, 20221 min read
USFDA Guidance on Technical Performance Assessment of Quantitative Imaging in Radiological Device
According to the guidance document, FDA recommends what information should be included in a premarket submission for radiological devices...
Sharan Murugan
Jun 18, 20221 min read
USFDA Guidance - Assessment of the UI of a Drug-Device Combination - Pre-ANDA or ANDA Communication
FDA published a new Manual of Policies and Procedures (MAPP), “Assessment of the User Interface of a Drug-Device Combination Product...
Sharan Murugan
Jun 16, 20221 min read
Malaysia’s - DRAFT GUIDANCE DOCUMENT LICENSING FOR ESTABLISHMENT
Malaysia’s Medical Device Authority (MDA) & Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated guidance updates...
Sharan Murugan
Jun 16, 20221 min read
USFDA's Guidance of Electromagnetic Compatibility (EMC) of Medical Devices
On 3 June, USFDA's Center for Devices and Radiological Health & Center for Biologics Evaluation and Research released updated guidance...
Sharan Murugan
Jun 7, 20221 min read
Q&A Guidance on Unique Device Identification system - Medical Device Coordination Group
On 20 May 2022 MDCG, the Medical Device Coordination Group of the European Commission has released a question and answer guide for the...
Sharan Murugan
May 24, 20221 min read
Cybersecurity of Legacy Medical Devices - Guidance-IMDRF
The International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Guide (MDCG) Working Group Proposed document...
Sharan Murugan
May 11, 20221 min read
USFDA: Activities and Engagement with the Voluntary Improvement Program
The FDA’s Center for Devices and Radiological Health (CDRH) is issuing this draft guidance to describe its policy regarding FDA’s...
Sharan Murugan
May 8, 20221 min read
Guidance on Classification of Rehabilitation Medical Devices -Malaysia’s MDA
Malaysia's Medical Device Authority (MDA) has drafted a guidance that will assist manufacturers and authorized representatives to...
Sharan Murugan
May 2, 20221 min read
SFDA's Product Classification Guidance
On 20 April, 2022 the Saudi Food and Drug Authority’s (SFDA’s) updated its Product Classification Guidance. This guidance presents the...
Sharan Murugan
Apr 24, 20221 min read
Malaysia’s MDA- Draft Medical Device Labeling Guidance
The Medical Device Authority (MDA) of Malaysia is seeking feedback on draft regulations for medical device labeling. The MDA's fifth...
Sharan Murugan
Apr 24, 20221 min read
Draft Guidleline on Change Notification For Registered Medical Device-Malaysia’s MDA
This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their...
Sharan Murugan
Apr 17, 20221 min read