Aftab Alam Jehan

Products Under Supervision

Aesthetic and Medical Devices, Body Contouring & Stimulation Devices Urology & Gynecology Devices, Laser & Light-Based Devices, Other Aesthetic/Non-Medical Devices , Botulinum toxins (Botox), Hyaluronic acid fillers, Sterile absorbable poly-L-lactic acid fillers, polymethyl methcrylate fillers, Amino acid & polypeptide fillers, Face lifting threads (mesothreads), Dermal fillers (including hyaluronic acid derivatives for aesthetic use), Hypodermal, subcutaneous & endodermal injection devices, Body contouring analyzers, High-intensity electromagnetic radiation-emitting analyzers, Muscle strengthening devices via neuromuscular stimulation, Analyzers for benign prostatic hyperplasia (BPH), Stress urinary incontinence treatment devices, Vaginal tightening and rejuvenation devices, High-intensity infrared, visible, and ultraviolet radiation-emitting equipment (e.g., lasers), Transcranial nerve stimulation devices, Liposuction equipment, Cosmetic devices, Contact eye lenses (non-medical use), Aesthetic implants, Cosmetic actives, additives, and excipients, Hyaluronic acid and derivatives, fillers and thixotropic formulations, Serum, ointments, and lotion bases, antimicrobial agents, suspending agents, binders, disintegrants, Flavourants, colourants, coatings, and dissolution agents.

MDR 2017/745 Annex XVI products

• Class I (including sterile, surgical reusable, and measuring devices)
• Class IIa & IIb (implantable and non-implantable)
• Class III (implantable and non-implantable)
• CE marking and EUDAMED registration
• Technical documentation and conformity assessment procedures
• Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS), and Post-Market Clinical Follow-up (PMCF)
• Periodic Safety Update Reports (PSUR)
• Corrective and Preventive Actions (CAPA)
• UAE MOHAP, EMA, and US FDA submissions
• CE marking, 510(k), PMN,
• Pharmaceutical eCTD (Modules 1–5) ,ANDA, INDA, NDA
• Dossier preparation for APIs, conventional medicines, and aesthetic medical devices
• Expertise in Cosmetic and pharmaceutical Ingredients, regulatory & quality System Expertise, medical device classification, conformity assessment & technical documentation, regulatory submissions ISO Standards Applied Quality Management System,
• Risk Management & Product Information: ISO 14971, ISO 20417, ISO 15223-1
• Needles, Syringes & Injection Devices: ISO 7864, ISO 9626, ISO 6009
• Biological Evaluation of Medical Devices (ISO 10993 Series)
• Sterilization: ISO 11135 (Ethylene oxide), ISO 9001: QMS
• SOP and quality manual development

1. Regulatory Authorities and Systems in UAE Ministry and Government Entities Customs Compliance 2. Regional and International Regulatory Markets Middle East & Africa North America & Europe 3. Saudi FDA (SFDA) Regulatory Activities 4. Sudan (National Medicines and Poisons Board – NMPB) 5. Quality Management Systems (QMS) ISO & GMP Standards Sterilization & Packaging Standards Biological Evaluation (ISO 10993 Series) Other Relevant Standards 6. Technical Documentation and Conformity Assessment Documentation Requirements Conformity and Certification 7. Post-Market and Clinical Evaluation Surveillance and Vigilance Clinical Documentation Clinical Trials

• MOHAP (Ministry of Health & Prevention UAE) Classification and registration of medical and in-vitro diagnostic (IVD) devices Import/export permits Adverse event reporting (medical device vigilance) Post-Market Surveillance (PMS)
• Tatmeen Platform Track and trace system upgradation for medical devices and pharmaceuticals
• Other UAE Entities: Muntaji (Dubai Municipality) ESMA (Emirates Authority for Standardization and Metrology) MOIAT (Ministry of Industry and Advanced Technology) ECAS (Emirates Conformity Assessment Scheme) FANR (Federal Authority for Nuclear Regulation) SIRA (Security Industry Regulatory Agency) MOFA (Ministry of Foreign Affairs) Ministry of Climate Change & Environment
• HS Code/Tariff code selection, substitution, and classification
• Documentation for customs declarations
• Bill of entry filing and amendments
• Distributor registration & product classification: Sudan, Iraq, Pakistan, KSA, Bahrain, Oman, Ethiopia
• Regulatory frameworks in: UAE, Saudi Arabia (SFDA), Sudan (NMPB), Ethiopia, Oman, Bahrain
• US FDA: 510(k) (Pre-Market Notification) PMA (Pre-Market Approval) IDE (Investigational Device Exemption) HDE (Humanitarian Device Exemption) HUD (Humanitarian Use Device) De Novo pathway for novel devices Expedited pathways for critical or underserved devices QSR / CFR Part 820 (Quality System Regulation)
• European Union: EU MDR 2017/745 & IVDR 2017/746 Transition from MDD/AIMD/IVDDCE marking, classification, and conformity assessment procedures
• Medical Devices Marketing Authorization (MDMA)
• Medical Devices National Registry (MDNR)
• Medical Devices Establishment Licensing (MDEL)
• Authorized Representative (AR) requirements
• Product registration, classification, and post-market surveillance
• SFDA website/software knowledge
• Application for medical devices and accessories
• Device classification based on: Public health risk Safety and intended use
• ISO 13485 – QMS for medical devices
• ISO 14971 – Risk management
• ISO 9001 – General QMS and QA
• cGMP – Implementation in manufacturing, distribution, servicing, and installation
• ISO 11135 (EO sterilization)
• ISO 17665-1 (Moist heat sterilization)
• ISO 11737-1 & 11737-2 (Bioburden and sterility testing)
• ISO 11607-1 & 11607-2 (Packaging for terminally sterilized devices)
• ISO 14644-1 (Cleanroom classification)
• Part 1: Evaluation and testing
• Part 3: Genotoxicity
• Part 5: Cytotoxicity
• Part 6: Local effects after implantation
• Part 10: Irritation and sensitization
• Part 11: Systemic toxicity
• ISO 14155 (Clinical investigations)
• ISO 14630 (General safety for non-active surgical implants)
• Technical file and technical dossier
• General Safety and Performance Requirements (GSPR)
• Design history file (DHF)
• Design master record (DMR)
• Labels and Instructions for Use (IFU)
• Risk analysis, verification, and validation reports
• CE marking steps and requirements
• ISO 13485, ISO 9001, ISO 14001 as part of conformity
• 510(k), PMA, and other safety/conformity routes
• Post-Market Surveillance (PMS) – Reactive and proactive
• Post-Market Clinical Follow-up (PMCF)
• Post-Market Performance Follow-up (PMPF)
• Vigilance system audits
• Periodic Safety Update Reports (PSUR)
• Risk-benefit analysis and corrective actions
• Clinical Evaluation Reports (CER)
• Clinical investigations
• Periodic performance/safety evaluation
• Scientific validity, analytical and clinical performance reports
• Exploratory, pilot, and pivotal studies
• Clinical investigations during PMCF/PMPF phases

Experienced in the classification and registration of rapid diagnostic tests (IVDs), surgical/medical equipment, lab reagents, analyzers, and disposables across regulatory bodies. Skilled in IVD risk classification based on public and individual health safety, and managing inventory control, import/export permits, documentation, and quality assurance.

In quality assurance and quality control, Practiced and implemented ISO 9001 QMS across manufacturing sections including tablets, capsules, and dry suspensions, with hands-on execution of quality control tests such as dissolution, disintegration, and analysis of active ingredients and excipients.