All Blog Posts (1,497)

Introduction

The Factories Act, 1948, is a comprehensive legislation enacted to regulate labor welfare, safety, and working conditions in manufacturing establishments. It mandates Factory Act Registration for units meeting specific criteria, ensuring legal compliance and protection of workers. However, the implementation of the Act varies across states in India due to different industrial landscapes, state-specific rules, and administrative…

Introduction

The print media industry in India is regulated by the Registrar of Newspapers for India (RNI), which ensures that newspapers and periodicals comply with the Press and Registration of Books Act, 1867. If you are planning to start a newspaper, magazine, or journal, obtaining RNI registration is a mandatory step. This article provides a comprehensive guide to RNI registration, covering its importance, eligibility, application process,…

For businesses engaged in agricultural exports, maintaining a valid APEDA registration is essential for uninterrupted operations. The Agricultural and Processed Food Products Export Development Authority (APEDA) provides exporters with a Registration-cum-Membership Certificate (RCMC), which facilitates global market access. While APEDA registration is…

The Restriction of Hazardous Substances (RoHS) directive plays a crucial role in ensuring that electrical and electronic products meet environmental safety standards. Compliance with RoHS regulations is not just a legal necessity but also an essential step in gaining market access in regions like the European Union, India, and other countries that have adopted similar regulations.

One of the most critical decisions in the compliance journey is selecting the right…

The Uttar Pradesh Pollution Control Board (UPPCB) plays a crucial role in regulating industries and ensuring environmental compliance in the state. Businesses that deal with manufacturing, processing, or any activity that may impact the environment must obtain Consent to Establish (CTE) and Consent to Operate (CTO) under the Air and Water (Prevention and Control of…

Breast cancer is influenced by a combination of genetic, environmental, and lifestyle factors. While you can't change your genetic makeup, making certain lifestyle changes can significantly reduce your risk of developing breast cancer. Here are some detailed tips on diet, exercise, and other lifestyle choices that can help lower the risk.

Diet and Nutrition

1. Eat a Balanced Diet:

• Focus on a diet rich in fruits,…

Introduction to CDSCO Import Licensing for Medical Devices in India

When it comes to importing medical devices into India, the Central Drugs Standard Control Organisation (CDSCO) is the key regulatory authority. Every medical device entering the Indian market must comply with the regulations set by CDSCO, ensuring the safety and efficacy of the product. CDSCO is responsible for setting the standards for drugs and medical devices…

The medical device industry changes constantly as new innovations and advancements are made in development, medical IT, and healthcare. Our medical device blog features expertise from the Sterling Medical Devices team and the latest information and regulation changes in the medical device industry that you should be aware of.

The healthcare and wellness industry is shifting toward regulated, personalized,…

UKCA stands for United Kingdom Conformity Assessed, and is applied to products placed on the market in the UK. This replaces the CE mark, which – pending changes to legislation - is recognised in the UK until the 30th June 2023. So from this date onwards, medical device manufacturers need to comply with the new UKCA marking regulations.

manufacturers now need to plan for how they will obtain a UK Conformity…

What Does a FDA 510( k) Clearance mean?

Medical devices for human use within the United States must be submitted to the FDA to determine if the product is safe and effective. To do this, in utmost cases a company must compare their product to one formerly cleared by the FDA and give substantiation that their product is “ substantially equivalent ” to the preliminarily cleared( legally marketed) device. To be mainly original, the product…

The US Food and Drug Administration has published a largely anticipated proposed rule to harmonize its medical device quality management system( QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard. 

FDA’s proposed rule “ would harmonize quality management system conditions for FDA- regulated devices with conditions used by numerous other regulatory authorities around the world, ” the agency countries.…

With any environmental management system (EMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.

This webinar will discuss these plans in detail so that you can not only meet the requirements of the Iso 14001 standard, but also reduce your environmental impact when problems occur.



In the webinar we will look at:

• What ISO 14001 means by an emergency…

With any occupational health & safety management system (OHSMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.

This webinar will discuss these plans in detail so that you can not only meet the requirements of the Iso 14001 standard, but also reduce your OH&S impact when problems occur.



In the webinar we will look at:

• What ISO 45001 means by an emergency…

Attend this webinar to learn how to understand control charts and their underlying statistics, how to choose variables to monitor, how to maintain the records and to plan adjustments.

There will be examples and walkthroughs of control chart implementation and use. A review of the relevant statistics will also be done.

With any occupational health & safety management system (OHSMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.

This webinar will discuss these plans in detail so that you can not only meet the requirements of the Iso 14001 standard, but also reduce your OH&S impact when problems occur.



In the webinar we will look at:

• What ISO 45001 means by an emergency…

This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers.

Learn how to prevent quality and compliance problems by having a strong system for supplier audit and management! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for managing your suppliers.



You'll learn about the essential elements of…

This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs.

Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce safe and effective products.

Because Production and Process Controls are so critical they are one of the major subsystems emphasized in inspections by the FDA.

Failure to adequately implement Production and Process Controls (P&PC) can lead to disaster for your company or even worse for your customer. And…

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential…

The US business environment as well as those of other countries have experienced over the years significant risk events with significant negative risk consequences. In recent times there have been a plethora of risk episodes in the corporate world.

Many of these episodes could have been avoided or modified if the entities…