MPCC is a regional leading medical device consultancy firm, offering a range of services for the local entities & overseas manufacturers in Medical Devices field, including a full spectrum of Representative, Regulatory Affairs and Compliance consulting services.
We have proven regional expertise, provide comprehensive solutions, and focus on robust services that makes us a trusted leader in Medical Device Services.
Medical Devices Services
Register the local entity in SFDA platform - GHAD.
Applying for warehouse certificate.
Establishment Importation & Distribution License (MDEL).
Authorized Representative (AR).
Medical Device Marketing Authorization (MDMA).
Reporting Medical Device Incidents & Adverse Events to SFDA (NCMDR)
Medical Device Import Permission (MDIL).
Medical Device clearance – Faseh platform.
UDI Data Submission to SFDA.
Technical Files Services
Technical File Evaluation.
Technical File Preparation, including but not limited.
Post-Market Clinical Follow-Up (PMCF) Plan & Report.
PMCF Conducting in KSA.
Post-market Surveillance (PMS) Plan & Report.
Pre-Market Clinical Studies (PMCS).
Clinical Evaluation Plan & Report (CEP & CER).
Biocompatibility Study.
Quality Management Services
ISO 13485 Issuance.
Quality Management system.
Annual Audit Surveillance.
Other Services
Response to SFDA inspection report.
Advertising & Promotional materials approval from SFDA.
Products classification.
Renting space from a warehouse.
