Materiovigilance Services in India – Stay Compliant with ACPL

In a country like India where the healthcare sector is rapidly evolving, ensuring the safety and performance of medical devices is of utmost importance. This is where Materiovigilance plays a critical role. At Accredited Consultants Pvt. Ltd. (ACPL), we provide expert guidance and end-to-end support for Materiovigilance compliance to medical device manufacturers, importers, and distributors.

🔍 What is Materiovigilance?

Materiovigilance is the systematic monitoring and evaluation of adverse events associated with medical devices. It ensures that devices used by healthcare professionals and patients are safe, effective, and perform as intended, even after they enter the market.

In India, this is regulated under the Materiovigilance Programme of India (MvPI), governed by the Indian Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organization (CDSCO).

🛠️ ACPL’s Materiovigilance Services

With years of expertise in regulatory consulting, ACPL helps clients establish and maintain compliant Materiovigilance systems. Our key services include:

✅ Support in Setting Up a Materiovigilance System

✅ Preparation of SOPs for Vigilance Activities

✅ Medical Device Adverse Event (MDAE) Reporting

✅ Training & Awareness for Staff and Distributors

✅ Risk Assessment & Field Safety Corrective Actions (FSCA)

✅ Periodic Safety Update Reports (PSURs) Submission

✅ Assistance with CDSCO Communication & Audits

💡 Why is Materiovigilance Compliance Crucial?

🛡️ Protects Patient Health and Safety

📊 Ensures Transparency and Risk Management

📈 Improves Product Quality and Reputation

✅ Mandatory for CDSCO Licensed Manufacturers/Importers

🔍 Helps in Detecting Product Defects or Malfunctions Early

👨‍⚕️ Who Needs Materiovigilance?

Medical Device Manufacturers & Importers
Authorized Agents and Distributors
Hospitals & Clinical Establishments
Any entity involved in post-market surveillance of medical devices

🚀 Why Choose ACPL?

🏢 Over 25 years of regulatory expertise

💼 In-depth understanding of CDSCO & IPC requirements

🔍 Detail-oriented approach to documentation and audits

📞 Ongoing support for reporting and corrective actions

🌐 Serving clients across India from our Noida headquarters

📍 Let’s Keep Devices Safe, Together

Partner with ACPL to build a robust Materiovigilance framework that ensures compliance while prioritizing patient safety. We help you stay aligned with India’s regulatory expectations—efficiently and transparently.

📞 Contact Us:

Accredited Consultants Pvt. Ltd. (ACPL)
📍 B-3, Sector-6, Gautam Budh Nagar, Noida – 201301, Uttar Pradesh, India
📞 +91-9266665201 | +91-931004043
📧 info@acplgroupindia.co.in
🌐 www.acplgroupindia.co.in