The use of red/brown- and green-colored dots to classify vegetarian or non-vegetarian is a mandated practice for food products in India. These dots are labeled on the food products’ packaging. However, there is no such system for cosmetics in India that declares their vegetarian or non-vegetarian nature.
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October 12, 2021 Cosmetics Regulatory Services, Regulatory Affairs -
October 6, 2021 Food and Food Supplements, Regulatory AffairsThe Food Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 was implemented on January 1, 2018.
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September 24, 2021 Medical Devices, Regulatory AffairsMedical device Post Marketing Surveillance (PMS), an important practice in the entire pharmacovigilance activity, is the process of ensuring the continued safety and efficacy of the device after it is approved and marketed. When the medical device is launched in the market, it is used by a large number of the general population with various medical conditions.
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September 24, 2021 Medical Devices, Regulatory AffairsTherapeutic Goods Administration (TGA), under the ‘Therapeutic Goods Act 1989,’ is entitled to regulate medical devices placed and marketed in Australia. Medical devices are regulated under the Therapeutic Goods (Medical Devices) Regulations, 2002. Initially introduced in 2002, the regulations underwent multiple amendments at a frequency of at least once a year, almost every year.
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September 20, 2021 Medical Devices, Regulatory AffairsThe medical devices market in Mexico is growing significantly and is expected to reach USD 7.6 billion by 2025. It is considered a tough market in terms of medical device regulations. The Federal Commission regulates medical devices in Mexico for the Protection against Sanitary Risk, i.e., COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios).
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September 20, 2021 Medical Devices, Regulatory AffairsA Medical Device Establishment Licence (MDEL) is a license issued to Class I medical device manufacturers, importers, or distributors of all device classes.
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September 20, 2021 Pharmaceuticals, Regulatory AffairsRecently, the Director-general – NAFDAC announced the commencement of a Sensitization Campaign in Nigeria. Through this campaign, NAFDAC intends to inform, sensitize and educate the Nigerian citizens about the dangers of intake and use of bogus medicinal products surfacing the market.
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September 17, 2021 Medical Devices, Regulatory AffairsThe US FDA has published a guidance document that will help the industry and the Health Agency (HA) staff determine when a software change to a medical device requires a manufacturer to submit and obtain the FDA clearance of a new premarket notification (510(k)).
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September 16, 2021 Publishing & Submissions, Regulatory Software & ServicesAs many of the Health Authorities transitioned from paper documentation format to the eCTD format, it is time for organizations to define key measures to submit documents in the electronic format to remain compliant.
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September 16, 2021 Chemicals, Cosmetics Regulatory ServicesIdentification of the product category is perhaps the most crucial step to comply with the Regulatory requirements in the European market. The identification process can be quite challenging as many products fall under two (02) or more categories and are affected by different Regulatory frameworks. Such products are referred to as borderline products.