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The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.
Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.
Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.
Ministry of Ecology and Environment (MEE) of China published the revised law for new chemical substances on May 7, 2020, which is said to be replacing the existing legislation, MEP Order 7, from Jan 1, 2021. The new update focuses on the major changes that MEE Order 12 has introduced and their implications for the industry from a legal standpoint. Let us have a brief look at it.
The Product Information File (PIF) is one of the key elements for ensuring successful market entry of a cosmetic product in the European market. As per the Cosmetic Regulation 1223/2009, a PIF helps the concerned authorities of the European Union (EU) to monitor the safety of cosmetic products available in the market. Therefore, it is crucial for cosmetic product manufacturers to file it...
e-labeling plays a critical role in the medical devices industry, as it ensures to improve operational efficiency, maintain brand consistency, obtain compliance and support business growth. Hence, the device industry is moving towards adopting end-to-end e-labeling life cycle procedures, starting from label content creation to review and approvals. How are they beneficial and what kind of...
Biocidal Products protect humans, animals and materials against harmful organisms like bacteria. Biocidal product regulation (BPR) aims to ensure a high level of protection for humans and environment and improve the functioning of the Biocidal products’ market in the European Union (EU).
The European Commission (EC) has provided clarification on the deadlines for updating their REACH registration dossiers. The requirement to update the dossiers ‘without undue delay’ is specified as three (3) months in most cases and up to twelve (12) months in complex cases.
According to the REACH regulation, if there is any change in the chemical data, company information or tonnage...
As it is well known, Medical masks to be launched in the Kingdom of Saudi Arabia (KSA), must obtain Medical Devices Marketing Authorization (MDMA). In reference to the same, the Saudi Food and Drug Authority(SFDA) has recently released a guidance to specify and clarify the requirements and recognized standards to streamline products’ market-entry.
The guidance is applicable to...
To market a dietary supplement with a “New Dietary Ingredient (NDI)” in the United States (US), manufacturers are required to submit a notification to the Food and Drug Administration (FDA). This requirement falls under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and it is aimed at ensuring the safety of ingredients used in dietary supplements under the specified and...
The NPRA Malaysia has updated, “Guidance Notes for Active Pharmaceutical Ingredient (API) Information Required for Product Registration” - Version 5.0 (June 2020). The guidance helps API manufacturers to expedite the registration process. Further to this update, a temporary notice on mode of DMF submission has also been provided as below.
Many countries are currently under...
Imported Cosmetic products are regulated in India under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945. For importing Cosmetics in India, the products are required to be registered with the Central Drugs Standards Control Organization (CDSCO) by giving an application in Form 42 to obtain the Registration certificate in Form 43. For this, along with other mandatory...
In a recent development, the US FDA has released a new guideline to assist the microneedling device manufacturers understand the product classification, applicable regulations, registration pathways and data requirements.
Microneedles are an array of blunt or sharp micro-protrusion pins, tips or needles of varying lengths. These products may be used by...
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