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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...
Notified and Non-Notified Medical Devices: Key Differences
In this blog, we have focused on the differences between notified and non-notified medical devices in India. Additionally, we have provided an overview of the different regulatory processes for different categories of medical devices. Furthermore, we have touched upon...
Clean Room for Medical Device Manufacturing Factory: A Guide
Clean rooms are crucial for manufacturing industries where product quality is easily affected by factors, such as airborne particles. Thus, clean rooms are pivotal in a medical device manufacturing industry. Medical device quality affects the patient outcome. Hence,...
Designing and Manufacturing Implantable Medical Devices
Advances in biomedical engineering and medical electronics have led to the development of implantable medical devices. These devices are implanted in the human body for improving the patient’s quality of life. Over the past few decades, implantable medical devices...
A Detailed Guide on How to Import Cosmetics from UK into India
Cosmetics are in high demand in India. Moreover, a significant portion of the Indian consumer base prefers imported cosmetic. Out of the many countries from which cosmetic products are imported into India, UK is one of the popular hotspots. For the safety of the...
CDSCO IVD Classification: Everything You Need to Know
In-vitro diagnostic devices are instruments, reagents, or systems intended to diagnose a disease or other health conditions. IVD tests are usually performed in test tubes and similar equipment outside the body. Moreover, the tests can be performed using various...
Indian Cosmetics Labelling Guidelines: Cosmetics Rules, 2020
The Drugs & Cosmetics Act provide the guidelines for labelling cosmetics. Certain mandatory declarations have to be mentioned on the labels of the cosmetics products to be sold in India. Furthermore, specific requirements for outer and inner labels of the...
In Process Quality Control: IPQC in Pharmaceutical Industry
Pharma companies are required to prevent substandard pharmaceuticals from entering the market. Thus, drugs have to be tested for efficacy, quality, and safety. Additionally, regulatory bodies require pharma companies to test the drugs manufactured for identity,...
Regulations for Conducting Clinical Trials in India: A Guide
Clinical trials are conducting for evaluating the safety of new drugs prior to launching them. India has unique advantages for conducting clinical trials. India has trained investigators, large patient pool, and premiere research institutes. Additionally, India has...
Primary and Secondary Packaging in Pharmaceutical Industry
Drug quality and efficacy impact the treatment outcome for patients. Hence, it is vital the quality of drugs remains intact till they reach the patients. The packaging of drugs protects them from damage, germs, outer atmosphere, and bacteria, thereby preserving the...
Need & Importance of Pharmaceutical Industry Quality Assurance
In this blog, we have explained what is pharmaceutical industry quality assurance and provided tips for effectively implementing it. Additionally, we have detailed on the importance of quality assurance in pharmaceutical industry. What is quality assurance in...
National Single Window System (NSWS) Portal: An Overview
With the consistent rise in demand for medical devices and pharmaceuticals, a streamlined regulatory approval system was very necessary. Moreover, India is aiming to become the global hub for medical devices and pharmaceuticals. Thus, a platform for seamless and...
19 Common FAQs on Indian Regulations for IVDs
Invitro diagnostic devices have a vital role in the healthcare industry. Thus, the invitro diagnostic devices in India are stringently regulated to ensure patient safety. However, the Indian regulations for IVDs are confusing. Hence, we have curated some common...
How to Set Up a Cosmetics Manufacturing Factory in India?
India has witnessed a consistent growth in the cosmetics market. Furthermore, the Indian beauty and cosmetics market is considered one of the fastest-growing sectors in the world. The passion for skincare and beauty is consistently increasing. With increasing access...