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India Rejects IVD Clinical Trial Waiver: Latest IVD Guidelines
In-vitro diagnostic devices (IVDs) are instruments, reagents, or systems used to diagnose a disease or other health conditions. IVD tests are usually performed in test tubes or other similar equipment outside the body. Moreover, the tests can be performed using...
5 Key Changes in Revised Schedule M: A Comprehensive Guide
Significant changes in Revised Schedule M guidelines have been introduced to safeguard patients and improve the Indian pharmaceutical industry’s reputation. These new guidelines are aimed at changing the way pharmaceuticals are manufactured in India. For further...
Starting an IV Set Manufacturing Business in India: Your Guide
IV set, also known as intravenous set, is a collection of devices used for administering intravenous treatments. IV sets are available in different styles that have been designed for specific therapeutic needs. These medical devices are essential for delivering safe...
Monitoring Imported Medical Devices Quality: Risk-based Approach
The Indian government aims to regulate the quality of imported medical devices. It wants to ensure only high-quality medical devices enter the Indian market. The aim is to prevent substandard medical devices from reaching Indian patients, thereby protect the public...
Quality Control for Medical Textiles: Overview of the New Order
Medical device quality and safety have been the top priority for India’s medical device regulatory authorities. Given the impact of medical devices on healthcare, quality of their raw materials has to be strictly regulated as well. Hence, the Indian Ministry of...
What Are the ISO Standards for Medical Devices? An Overview
High-quality, efficacy, and safety are of paramount importance in the medical device industry. Medical devices are required to perform as intended for effective health care delivery. Hence, regulatory guidelines and industry standards have been set to monitor medical...
Starting an Oxygen Manufacturing Plant in India: Your Quick Guide
Starting an oxygen manufacturing plant in India can be a high potential business opportunity. Medical oxygen will always be in high-demand in the healthcare sector. Hence, manufacturing oxygen to cater to hospital demands will have a bright future. However, for...
CDSCO COS-8 License: Cosmetics Manufacturing License in India
India is a potential market for cosmetics and beauty products. With the increase in disposable income, people are spending considerably on cosmetic products. Thus, the beauty industry in India is booming. Market experts have predicted a bright future for the Indian...
CDSCO Shampoo Registration in India: Permission and Licenses
Hair care products are in high demand in the Indian cosmetics industry. They have a vital role in Indian consumer’s beauty regimen. Easy access of consumers to global beauty trends is driving the hair care market. Notably, shampoo forms the crux of hair care products...
How to Apply for Free Sale Certificate for Medical Devices?
Medical devices are the backbone of the healthcare sector. These devices are used to perform real time diagnosis of various diseases/conditions as well as treat and monitor them. India is set to become a global medical device manufacturing hub, with the aim of...
Securing CDSCO Wet Wipe Manufacturing License in India
Wet wipes are moistened pieces of paper or non-woven fabrics that are used to clean surfaces. These premoistened wipes are usually available in small packs and are disposable. They are used to gently cleanse the skin. Additionally, they are used to remove impurities...
Documents Required for CDSCO MD-15 License Application: Your Guide
The CDSCO MD 15 license is granted for importing medical devices into India. It is the gateway for importing and selling imported medical devices in India. MD-15 license is a mandatory requirement for importing all Class A (measuring and sterile) B, C, and D medical...
Revised Schedule M Deadline Extension: Latest Notification Draft G.S.R. 10(E)
Revised schedule M is being mandatorily implemented in India. Thus, all pharmaceutical manufacturing units in India need to strictly comply with the Schedule M guidelines. Notably, the focus of Schedule M is the production of highest quality pharmaceuticals in India....
CDSCO List of Cosmetics Items: Everything You Need to Know
India is a potential market for cosmetics and beauty products. The beauty industry in India is booming. Moreover, there is a high demand for imported cosmetics products in India. Hence, cosmetics products to be imported into India are heavily regulated by the Central...
MoCRA Safety Substantiation Requirements for Cosmetics Industry
The Modernization of Cosmetics Regulation Act (MoCRA) focusses on increased product safety and manufacturer accountability. Cosmetics products have to be regulated so that they are safe for repeated and regular use. Notably, safety substantiation is one of the core...
MoCRA Cosmetics Facility Registration Guidelines: A Handy Guide
The Modernization of Cosmetics Regulation Act (MoCRA) has introduced an array of new requirements for the cosmetics industry. The act aims to standardise the regulatory framework of the cosmetics industry. Notably, MoCRA has transformed and modernized the US FDA...
What Are the Latest US FDA Cosmetics Labelling Guidelines?
Allergic reaction caused by contact with or consumption of allergens is a common issue. It can range from a mild rash to anaphylaxis that can even be fatal. Currently, there are extensive guidelines for labelling allergens in the food and beverage industry to protect...
Role of MoCRA Responsible Person in Guideline Compliance
The Modernization of Cosmetics Regulation Act (MoCRA) has introduced the concept of responsible person in the US cosmetics regulatory framework. Furthermore, under this act, new facility registration rules, product listings, SAE reporting, and safety validation...
CDSCO Gynaecological Medical Device License: Your Guide
Securing the CDSCO license for gynaecological medical devices is mandatory to launch your devices in the Indian medical device market. This requirement is in place to protect the public health and maintain the standard of the Indian healthcare system. To manufacture...
MoCRA Adverse Event Reporting: Everything You Need to Know
US FDA cosmetics regulatory laws have been transformed and modernized to ensure consumer safety. The Modernization of Cosmetics Regulation Act (MoCRA) implementation ushers in the new era of cosmetics regulation. The act introduces an array of new requirements for the...
MoCRA GMP Guidelines for Cosmetics Industry: 12 Key Areas
Increased regulation and oversight of the quality and safety of cosmetic products are required to safeguard consumer health. Implementation of the Modernization of Cosmetic Regulation Act (MoCRA) has ushered in a new regulatory era for the cosmetics industry. As...
Modernization of Cosmetics Regulation Act (MoCRA): Your Guide
Recently, the US laws for cosmetics have changed. They have been made comprehensive. The Modernization of Cosmetics Regulation Act (MoCRA) has been implemented to modernize and transform FDA cosmetic regulations. The aim is to improve product safety and protect...
CDSCO Operation Theatre Medical Device License Application
Operation theatre medical devices have a crucial role in facilitating surgeries and ensuring positive patient outcome. In addition to specialized equipment, basic general operation theatre medical devices, such as surgical table, have equally important roles....
CDSCO General Hospital Medical Devices License: Your Guide
Medical devices used by healthcare professionals to administer treatment and provide patient care fall under general hospital medical devices category. These are basic common medical devices required to provide treatments planned in the hospital. Additionally, general...
How to Obtain CDSCO Urological Medical Device License in India?
The field of urology deals with male and female urinary tract-related diseases. The primary focus is the functioning and disorder of kidneys, ureters, bladder, and urethra. Additionally, disorders of the male organs, such as penis, testes, scrotum, prostate, etc.,...
CDSCO Gastroenterological Medical Devices License: Your Guide
Gastroenterology is a field of medicine specifically focused on the digestive system and its associated disorders. Colonoscopy, stool test, barium swallows, and endoscopy are some of the common tests performed by gastroenterologists. Hence, special equipment and...
How to Obtain CDSCO Pain Management Medical Device License?
Pain management deals with the prevention of pain. This medicinal field is concerned with the evaluation, treatment, and rehabilitation of persons in pain. Notably, a comprehensive pain management approach guided by experts is the best way to tackle chronic pain. A...
CDSCO MD 15 License for Importing Medical Devices into India
India has a rapidly growing domestic medical device manufacturing industry. However, India still heavily relies on medical device imports to fulfil the requirements of the healthcare system. To import medical devices into India, importers have to mandatorily obtain a...
Wearable Medical Devices: Vital Component of Modern Healthcare
Globally and in India, the wearable medical device market is rapidly growing. Increasing health and fitness awareness, high chronic disease prevalence, and emphasis on preventive healthcare are driving this market. Furthermore, the government is trying to formulate...
6 Common Hazards in Medical Device Manufacturing Industry
Needless to say, in case of medical devices, patient safety is of utmost importance. Hence, medical device manufacturing process regulatory compliance is vital to ensure the device is safe and will perform as intended. However, worker safety is an equally important...
CDSCO Registration for Organ Preservation Solution: A Guide
CDSCO registration is needed to prevent spurious inferior quality medical devices from entering the Indian health care market. In this blog, we will focus on organ preservation solution that has been designated as a medical device by the CDSCO. We will delve into the...
New Opportunities in the Medical Devices Manufacturing Segment
The Indian medical device industry is witnessing a double-digit growth rate. It is one of the top 20 markets in the world and the 4th largest in Asia. Moreover, the Indian medical device market size is approximately $ 11 bn. Infrastructural upgrades and increasing...
Materials Used for Manufacturing Medical Devices: A Guide
When manufacturing medical devices, safety, regulatory compliance, performance, and resilience are the major factors to focus on. Furthermore, while choosing medical device manufacturing materials, biocompatibility, durability, and regulatory compliance are some of...
ISO 13485 Certification for Class A and B Medical Devices
In the medical device industry, safety and quality are non-negotiable. Hence, various regulatory guidelines govern the medical device industry to ensure high-quality, safe, and effective devices are being manufactured. One such guideline is ISO 13485 standards. ISO...
How to Identify a Predicate Device? A Detailed Guide
Planning to market your medical device in the US? Then, you will have to secure the US FDA 510(k) approval. For which you will require proper documentation and have to select the appropriate predicate device. You will need the predicate device to prove substantial...
US FDA 510(k) Dossier Preparation: Everything You Need to Know
510(k) submission is a specific type of regulatory premarket submission made to the Food and Drug Administration (FDA) for Class I, II, and III medical devices. This premarket submission is used to demonstrate evidence of substantial equivalence. The process is...
5 Pro tips for Hassle-Free US FDA 510(k) Submission
Compliance with US FDA regulations is mandatory for marketing and distributing medical devices in the U.S. The FDA 510(k) is a premarket submission process used to determine whether the medical device is safe and effective. Owing to incorrect application, thousands of...
Everything You Need to Know About CDSCO MD7 and MD9
The Central Drugs Standard Control Organization (CDSCO) regulates and controls medical devices entering the Indian market. Hence, medical device manufacturers will have to secure the CDSCO medical device manufacturing license to manufacture medical devices in India....
Using Artificial Intelligence in Medical Devices Industry
Artificial intelligence is a powerful and disruptive domain in the field of computer science. It empowers machines with the ability to perform tasks that usually require human intelligence. Furthermore, artificial intelligence (AI) enabled-machines match or improve...
Recent Reminder for CDSCO License Retention Fee Payment
CDSCO license for medical devices manufacture/import and registration certificates for QMS medical device testing labs are valid indefinitely. All licenses, Form MD-5, Form MD-6, Form MD-9, Form MD-10, and Form MD-15, are issued for an indefinite period. The validity...