Quality & Regulatory
Certified Quality. International Standards. Trusted Worldwide.
Supported by CE-certified product approvals and a certified quality management system for medical devices, Meghdoot Pharma provides advanced wound care solutions designed to meet the quality, safety, and performance expectations of modern healthcare environments.
4+
Global Certifications
Our quality management systems and manufacturing operations are independently audited and certified to ensure compliance with international medical device requirements.
European Union:
Certificate No.
QMS-13-010-2021/A
Initial Certification
15 February 2022
Current Issue Date
15 February 2025
Valid Until
14 February 2028
Certification Body
Procedo International Certification, Slovakia
Certificate Reference
1434-MDD-161/2021
Notified Body
NB 1434 – Polish Centre for Testing and Certification
Certificate Reference
1434-MDD-162/2021
Notified Body
NB 1434 – Polish Centre for Testing and Certification
Australia:
ARTG Entry
526052
ARTG Start Date
28/04/2026
Product Category
Medical Device Class III
Status
Active
Regulatory Authority
Therapeutic Goods Administration, Australia
Confirmation Reference
BM.433.0050.2024/KW/MC/2024/0174
Issue Date
06 May 2024
Manufacturer SRN
IN-MF-000011404
Product Classification
Class III
MDR Transition Validity
Until 31 December 2027, subject to ongoing MDR compliance requirements.
Compliance Transparency
Meghdoot Pharma operates under Manufacturer SRN IN-MF-000011404. Our transition to EU MDR is managed via a formal contract with Notified Body 1434, ensuring continuous compliance through December 2027.
Global Standards.
Growing Recognition.
Our commitment to quality, compliance and international regulatory standards continues to expand with every new market we enter.
We provide full access to our regulatory credentials for procurement teams, clinical auditors, and distribution partners.
Download All Certification Documents
Product Safety & Quality Framework
Quality is integrated throughout our manufacturing operations through defined processes, documented controls, and continuous monitoring to support product consistency, traceability, and regulatory compliance.
Our Quality Framework
01
Production carried out under controlled conditions.
02
Verification of materials and finished products.
03
Controlled sterilisation processes for sterile wound care products.
04
Complete documentation and product traceability.
05
Monitoring throughout key manufacturing stages.
06
Ongoing review and refinement of quality processes.
Partnering for Procurement Stability
We recognize that consistent product availability is the backbone of patient care.
Our manufacturing infrastructure operates under manufacturer SRN IN-MF-000011404, providing full regulatory traceability for institutional audits.
By combining EN ISO 13485:2016 certified quality systems with proactive inventory management, we offer a stable bridge between production and clinical demand.
Stable, long-term supply continuity tailored for hospital purchasing groups.
Full regulatory transparency from raw materials to the point of care.
Dedicated dossiers and certification support to expedite tender onboarding.
1. How does Meghdoot Pharma ensure continuous regulatory compliance during the EU MDR transition period?
We maintain active compliance through a formal contract with Notified Body 1434, ensuring our operations are under continuous surveillance. Our MDR transition status is confirmed until December 31, 2027, supported by our Manufacturer SRN (IN-MF-000011404) and rigorous adherence to ongoing regulatory reporting requirements.
2. What specific evidence of quality management is available for institutional and clinical audits?
For procurement teams and clinical auditors, we provide a transparent, centralized documentation portal. This includes our EN ISO 13485:2016 certification (QMS-13-010-2021/A), CE EC Design Examination certificates, and full access to our technical dossiers.
3. How is product traceability managed across international supply chains?
Traceability is integrated into our manufacturing framework via a mandatory batch-tracking system. Every unit produced under our Manufacturer SRN carries comprehensive documentation that links production data, sterilization validation logs, and material testing results, ensuring that healthcare providers can verify product history at every point of care.
4. How does your Quality Framework mitigate risks for large-scale hospital procurement groups?
We minimize supply chain risk through "controlled manufacturing conditions" and validated sterilization processes that eliminate variability. By maintaining an ISO-certified quality system alongside proactive inventory allocation, we provide hospital purchasing groups with the predictability required for long-term clinical supply continuity.
5. Are technical and regulatory dossiers available to expedite our internal tender onboarding process?
Yes. We understand that tender timelines are critical. We provide procurement teams with a curated compliance package, including Technical Data Sheets (TDS), Quality Certificates, and regulatory dossiers, specifically formatted to satisfy the requirements of international medical tenders and institutional onboarding procedures.
