Our Blog
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...
Capital Subsidy for Domestic Medtech Component Production
In addition to fulfilling its own demands, India caters to a considerable portion of the world’s needs for generic medicines and low-cost vaccines. Hence, it has earned the name “pharmacy of the world”. However, when it comes to medical devices, India’s medical device...
Clean Room Validation According to ISO 14644 Guidelines
Clean rooms have a vital role in the medical device manufacturing industry. In the medical device industry, product quality is easily affected by factors, such as airborne particles. Hence, clean rooms are required to maintain a sterile and clean environment....
Importance of Management Review Meetings: A Detailed Guide
Management review meetings or MRMs are vital for continuous improvement of the organisation and to achieve business excellence. Moreover, MRMs have a vital role in regulated environments, such as pharmaceutical, food, and medical devices industry. In this blog, we...
Common Types of Blenders Used in Pharma Industry: A Guide
Blending has a vital role in the pharmaceutical industry, as drugs are manufactured by mixing various components. It is the process of thoroughly mixing all the ingredients. Additionally, the blending has to be performed at a particular temperature either in dry or...
5 Tips for Medical Devices Export Without CE Marking
For medical device exporters, securing the CE marking for medical devices is a headache. Various requirements have to be fulfilled and different guidelines have to be followed to secure the medical device CE mark. So, the question usually asked is how to export...
Scheme Aimed at Promoting Domestic Medical Device Industry
The Indian government is aiming to make the domestic medical device industry self-reliant in the long run. Hence, it has rolled out various schemes to strengthen the medical device industry in India. These schemes align with the India’s vision of becoming a global...
Circular on Testing and Evaluation of Medical Devices and IVDs
Rigorous testing and evaluation of medical devices and IVDs is necessary to protect the public health. Medical devices and IVDs have a pivotal role in diagnosis and treatment of diseases and various medical conditions. Hence, regulatory officials have to ensure only...
Medical Device Design and Development as per ISO 13485:2016
Regulatory compliance and following international industry standards are vital for medical device production. Unlike other industries, designing and developing medical devices is a complex process because of regulatory demands. Any failure to meet regulatory design...
License For Conducting Clinical Investigation in India: A Guide
Medical device manufacturers/importers who wish to conduct a clinical investigation in India need to obtain permission from the CLA. The CLA is the Central Licensing Authority (CLA) and functions under the CDSCO. The CDSCO is the Central Drugs Standard Control...
India’s First Medical Devices Center of Excellence (COE)
The Government of India has taken several steps to support the Indian medical devices industry. The government aims to make India the global manufacturing hub for high-quality and safe medical devices. Initiatives have been taken to boost foreign direct investments,...
AiMeD Seeks Hike in Customs Duty for Medical Devices
The association of Indian medical device industry (AiMeD) is a platform for Indian medical device manufacturers and represents the Indian medical device industry. The platform acts as a single point of contact and provides various services to medical device...
5 Quick Tips on How to Reduce Downtime in Pharma Industry
In this blog, we have discussed why pharma companies should pay special attention to downtime, especially unplanned downtime.Additionally, we have provided some tips for reducing downtime in pharma industry. What is downtime? To reduce downtime in pharma industry, it...
12 Common FAQs on the Indian Drug Regulatory System
Pharmaceuticals sector is one of the fastest growing industries in the Indian market. This industry provides an excellent opportunity for starting a business. Hence, various entities are trying to tap into the potential of this sector. As high-quality affordable drugs...
Starting a Surgical Instruments Wholesale Business in India
The demand for surgical instruments in India is high. Hence, medical device companies are focusing on surgical instruments. However, there are various requirements that you have to fulfil to secure a surgical instrument wholesale license. In this blog, we have curated...