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Beauty Beyond Borders: A Comprehensive Guide to Cosmetic Regulations in Saudi Arabia

In recent years, the beauty and cosmetics industry has witnessed exponential growth worldwide, breaking down geographical barriers and creating a global marketplace. One countr...
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Symbols used in Labelling

There are multiple symbols used in labelling, but what are the harmonised standards that are internationally accredited. ISO 15223-1: 2021 – Medical Device Symbols rel...
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Risk Management of medical devices under MDR

All medical devices are associated with inherent risks of some level. It is imperative to understand the medical device’s specific risks to a patient. Under EU MDR 2017/745...
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Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023 

Introduction Recent amendments to Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), have introduced significant changes to the timelines and con...
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Navigating Biologic Product Registration in Thailand: TFDA Requirements, Procedures, and Validation Process

TFDA Requirements for Summary Product Characteristic (SPC) Name of the Medical Product  Qualitative And Quantitative Composition  Pharmaceutical Form ...
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Five minute reads

eCTD- Electronic Common Technical Document

eCTD-an overview In today’s economy, life science companies are seeking for strategies to continue growing despite impending patent expirations, increasing generic competition, and rising drug development costs.  The In...

Cosmetic Blogs

eCTD-an overview In today’s economy, life science companies are seeking for strategies to continue growing despite impending patent expirations, increasing generic competition, and rising drug development
New guidelines on how to distinguish between medical devices and medical products under the Medical Devices Regulation have been published by a working group of the European Commission (MDR). The new recomm
The term “animal testing” refers to procedures carried out on living animals for research into basic biology and diseases, evaluating the efficacy of new pharmaceuticals, and testing the safety of consumer
Cosmetic ingredients and products are not required to have FDA clearance before being sold in the U.S. The only exception is colour additives, which need to be authorised for their intended purpose (apart from
Title 21 of the Code of Federal Regulations (CFR), section 7.3(g), describes a recall as a firm’s removal or correction of a marketed product that FDA judges to be in violation of the laws we administer and
by OMC Medical | Dec 13, 2023 | Cosmetics, EU Understanding the distinctions between product classes within the European cosmetics landscape can be complex and ambiguous, often requiring input from au

Pharma Blogs

Medical Device Registration in Romania

Ministry of Health:      Ministry of Health Regulatory Authority:           National Agency for Medicines and Medical Devices of Romania (NA...

Pharma Blogs

TFDA Requirements for Summary Product Characteristic (SPC) Name of the Medical Product&nbs
The Indonesian Food and Drug Authority (BPOM) plays a crucial role in ensuring the safety and effic
MoH: Armenia Ministry of Health MoH website: https://www.gov.am/en/structure/1/ Reg
MoH: Ministry of Public Health MoH website: https://moph.gov.af/en Regulatory Autho
A medical device’s intended use and inherent risks must be considered when determining its MDR cl
Technical documentation should contain details of the medical device in a clear, organized, readily
“Professional use” Test Kit – Procedure for registration in UK  Novel Corona Virus Di
Labelling Requirements – Swiss Authorized Representative Written, printed, or graphic informat
Ministry of Health:      Ministry of Health Regulatory Authority:&nb

Medical Device and IVD Blogs

Switzerland Authorised Representative

Medical devices are regulated by: the Swiss Agency for Therapeutic Product Manufacturer Responsibility Ensuring medical devices are placed on the market is in accordance with the requirement of
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Switzerland Medical Device Regulations

Switzerland Market Situation As the Institutional Agreement is missing (InstA) is missing, the EU has not updated the Mutual Recognition Agreement (MRA) No barrier-free access to the EU internal market
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Swiss Regulation QA WHITE PAPER

MEDICAL DEVICE REGULATIONUPDATE IN SWITZERLAND 1. Who is responsible for medical device regulation in Switzerland? The Swiss Agency regulates medical devices for Therapeutic Products (Swiss medic) 2.
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Switzerland AR Responsibilities

Obligations of the Switzerland AR Responsibilities 1. Verify the DoC and technical documentation have been drawn up and where necessary conformity assessment procedure has been carried out. 2. Keep avail
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Swiss Manufacturer Obligations

1. Manufacturers outside Switzerland will need to appoint Swiss AR. 2. The Manufacturer will use commercially reasonable efforts to update its technicaldocumentation for the devices, to comply with the requ
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Labelling Requirements – Swiss Authorized Representative

Labelling Requirements – Swiss Authorized Representative Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices
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Nomenclature of Medical Devices

Medical device nomenclatures are those products used to prevent, diagnose, treat, and monitor the many diseases known to humankind. Medical devices and medicines play an equally important role in treating huma
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