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FDA's MAPP on Complex Product Classification for Generic Development
On 13 April 2022, the FDA's Office of Generic Drugs (OGD) published a draft manual of policies and procedures, (MAPP 5240.10) outlining...
Sharan Murugan
Apr 17, 20221 min read
FDA's Draft Guidance on Cybersecurity in MD: Quality System Consideration & Content of Premarket Sub
This draft guidance document is being distributed for comment purposes only. Cybersecurity incidents have rendered medical devices and...
Sharan Murugan
Apr 10, 20221 min read
Guidance on Requirements for Import / Re-export Medical Imaging Materials - SFDA
On 27 March,2022 the Saudi Food and Drug Authority (SFDA) released this guidance detailing the Requirements for the Import and Clearance...
Sharan Murugan
Mar 30, 20221 min read
Malaysia Draft Medical Device Guidance on PERSONAL PROTECTIVE EQUIPMENT (PPE) - REQUIREMENTS
The Malaysian Medical Device Authority (MDA) drafted a guideline on personal protective equipment (PPE) and seeks feedback from the...
Sharan Murugan
Mar 24, 20221 min read
Guidance on Innovative Medical Devices - Saudi Food and Drug Authority
Medical devices that are innovative play an important role in improving and facilitating the quality of life of both patients and...
Sharan Murugan
Feb 24, 20221 min read
Irelands HPRA Guide to Classification of a Medical Device
Throughout this guide, guidance is given on the qualification of medical devices and the application of classification rules. There is a...
Sharan Murugan
Feb 20, 20221 min read
Malaysia's Medical Device Authority Guidance on Refurbished Medical Devices.
Malaysia's Medical Device Authority (MDA) has published guidelines to help manufacturers and authorized representatives submit...
Sharan Murugan
Feb 13, 20221 min read
US FDA CDER Guidance Agenda -Calendar Year 2022
In 2022, CDER will publish new and revised guidances in its Guidance Agenda, which was released on January 31, 2022. The 2022 list...
Sharan Murugan
Feb 13, 20221 min read
Revision of PIC/S GMP Guide
On 1-February 2022, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week revised its good manufacturing practice (GMP)...
Sharan Murugan
Feb 6, 20221 min read
USFDA Guidance on Premarket Review of Combination Products
US Food and Drug Administration (FDA) has finalized guidance for industry and agency staff on the use of Principles of Premarket Pathways...
Sharan Murugan
Feb 6, 20221 min read
Patients’ Experiences & Engagements Medical Device Guidances - USFDA
US FDA issued two medical devices (final guidance documents on January 26, 2022, to help sponsors better incorporate and capture...
Sharan Murugan
Jan 27, 20221 min read
CHINA’S NMPA: Development Guideline of Drug-Device Combinations
China’s National Medical Products Administration (NMPA) released 2 guidelines supporting the development and registration of drug-device...
Sharan Murugan
Jan 23, 20222 min read
Regulating Medical Devices & Place on The Market – UK
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. This guide...
Sharan Murugan
Jan 7, 20221 min read
Unannounced Inspections in India And China to be Resumed Soon: USFDA
Senior US Senator Chuck Grassley has urged to "reinstate unannounced" inspections of prescription drug manufacturing facilities in...
Sharan Murugan
Dec 18, 20211 min read
Guidance for Declaration of Conformity - TGA
When applying for inclusion in the Australian Register of Therapeutic Goods (ARTG), different classes of medical device require different...
Sharan Murugan
Nov 28, 20212 min read
Draft Guidance for Device Software in Premarket Submissions - USFDA
This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket...
Sharan Murugan
Nov 7, 20211 min read
Imports & Exports of Therapeutic Goods - Pakistan (DRAP)
Drug Regulatory Authority of Pakistan (DRAP) has released draft guidelines that describe the requirements for commercial imports and...
Sharan Murugan
Nov 7, 20211 min read
Guideline for Registration of Drug-Medical Device & Med.Dev-Drug Combo Products - MALAYSIA -NPRA
Drug-Medical Device Combination Product (DMDCP): Primary mode of action is based on pharmacological, immunological or metabolic action...
Sharan Murugan
Nov 7, 20211 min read
EC MDCG Guidance on Legacy Medical Devices, Repackaging Data
The European Commission’s Medical Device Coordination Group (MDCG) released a document detailing how the newly implemented Medical Device...
Sharan Murugan
Nov 7, 20211 min read
Updated Guideline on Registry-Based Studies (EMA)
This guideline addresses the methodological, regulatory and operational aspects involved in using registry-based studies to support...
Sharan Murugan
Nov 7, 20211 min read