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Operational Qualification in Pharmaceutical Industry
Operational qualification has a vital role in ensuring high-quality products are being consistently manufactured. It is the third stage in the equipment qualification process. Operational qualification in pharmaceutical industry validates all equipment and sub systems...
Installation Qualification in Pharmaceutical Industry: A Guide
The equipment qualification process in pharmaceutical industry has four stages, design, installation, operational, and performance qualification. Installation qualification is the second stage of the pharmaceutical equipment qualification process. It lays the...
Design Qualification in Pharmaceutical Industry: 10 Tips
Equipment and machinery have an indispensable role in pharmaceutical manufacturing and quality control. Hence, they must pass the design qualification stage fulfilling predetermined user requirement specifications. Design qualification is the first step of the...
Revised Schedule M Deadline Extension Application Process
The CDSCO has now opened the portal for Revised Schedule M deadline extension application. Revised Schedule M deadline extension will be applicable only for small and medium scale businesses having a turnover of less than 250 crore. We have prepared a detailed guide...
DQ, IQ, OQ, and PQ in Pharmaceutical Industry
All pharmaceutical companies are required to abide by stringent regulations to ensure their products are safe and effective. Regulatory authorities specifically emphasize on qualification processes in pharma manufacturing facilities. The process of qualification aims...
20 Key Changes for Ayurvedic Manufacturers in Revised Schedule T Draft
The Schedule T guidelines for ayurvedic medicine manufacturers are being revised to improve the way ayurvedic medicines are manufactured. The aim is to ensure high-quality, safe, and effective ayurvedic medicines are being consistently manufactured. In this blog, we...
GMP and Schedule M Audit Service for Pharmaceutical Facilities
All pharmaceutical manufacturing facilities in India are required to comply with the Schedule M guidelines. The guidelines are intended to change the way pharmaceuticals are manufactured in India bringing them at par with global standards. However, ensuring compliance...
Manufacturing Orthopaedic Implants in India: 5 Key Points
Orthopaedic implants are medical devices commonly used to replace or support damaged or missing bones and joints. Different types of orthopedic implants are used in the healthcare sector. Each implant is designed for specific purposes and anatomical locations....
6 Reasons to opt for Medical Device Contract Manufacturing
In this blog, we have discussed medical device contract manufacturing service. Additionally, we have highlighted why new medical device companies or startups should opt for this service. Furthermore, we have tried to answer some common FAQs. Contract...
Manufacturing MRI Machines in India: Process & License Required
Magnetic Resonance Imaging (MRI) is an excellent non-invasive diagnostic imaging tool. It is used for detection of various diseases by providing precise contrast resolution. Additionally, it is used for treatment monitoring. MRI uses a sophisticated technology....
Common ISO 13485 Audit Mistakes You Can Avoid: 5 Easy Steps
In this blog, we have curated a detailed step-by-step guide to help you avoid the common ISO 13485 audit mistakes. Additionally, we have highlighted why should you bother with ISO 13485 certification and how to secure it. What is ISO 13485? ISO 13485 provides...
Checklist for MD 15 License Application: CDSCO Import License
Are you planning to import medical devices into India? The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices being imported into India. Hence, you will have to secure the CDSCO import license. We have prepared a checklist for MD 15...
Starting a Medical Device Manufacturing Unit in Saudi Arabia
Saudi Arabia is an emerging market for medical device manufacturers. The country is heavily invested in improving its healthcare infrastructure and patient care services. Additionally, Saudi Arabia is focussed on strengthening its medical device industry. Thus, Saudi...
Delays in Clearing Import of Medical Device Components
India is aiming to locally manufacture and assemble medical devices. Various components and parts have to be imported to manufacture life-saving medical devices. However, while importing medical device components and essential parts, medical device manufacturers are...
India’s Medtech Industry is Witnessing Export Growth
Witnessing unprecedented growth, India aims to become a global medical device manufacturing powerhouse. India’s medical device industry is focusing on transforming from an import dependant sector to a self-reliant manufacturing hub. The goal of India’s medtech...
Declaring Medical Device Equivalence: Key Criteria & Challenges
In this blog, we have provided an overview of what is medical device equivalence. Additionally, we have discussed the criteria and requirements that have to be fulfilled. Moreover, we have highlighted the common challenges encountered while trying to prove...
5 Tips for Conducting Effective Medical Device Market Research
Medical devices form the backbone of the healthcare sector. The diagnosis and prognosis of a disease or a medical condition depends on the effectiveness of the medical device. Hence, medical device entrepreneurs are constantly trying to tap into the potential of the...
SOPs for Medical Device Startup: 7 Key Medical Device SOPs
Medical device industry is highly regulated. Various documents are required to demonstrate regulatory compliance. Standard operating procedures (SOPs) are one such essential document required for medical device approval and market launch. SOPs outline the framework...
4 Key Steps for Effective Internal Audit of ISO 13485:2016 QMS
QMS helps ensure medical devices being manufactured are consistently meeting strict quality standards, thereby ensuring their safety and efficacy. A robust QMS helps medical device manufacturers reduce errors, minimize risks, and ensure product quality. The ISO...
Effective Risk-Based CAPA in Quality Management System
Corrective Action Preventive Action (CAPA) focuses on eliminating the root cause of non-conformities It is a systematic approach aimed at mitigating the risks of undesirable events and non-conformities. CAPA forms the core of quality management system (QMS) in...
Starting an IVD Manufacturing Plant in India: Your Quick Guide
In this blog, we have curated a detailed guide for starting an IVD manufacturing plant in India. Additionally, we have discussed the necessary CDSCO license required for setting up an IVD manufacturing facility. What are IVDs? IVDs or in vitro diagnostic devices are...
List of Refurbished Medical Equipment for Import: Key Conditions
In this update, we have provided the revised list of refurbished medical equipment for import provided by the Centre. Additionally, we have listed the major conditions for importing refurbished medical equipment into India. Revised list of refurbished medical...
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...