Medical Device

Related Regulations

• EU MDR (Regulation (EU) 2017/745) — European Union
• EU IVDR (Regulation (EU) 2017/746) — In Vitro Diagnostic Devices
• US FDA 21 CFR Part 800–1299 — United States Medical Device Regulation
• ISO 13485 — Medical Device Quality Management System
• ISO 14971 — Risk Management for Medical Devices
• IMDRF Guidance Documents — Global Harmonization Framework

Target Products

Medical devices intended for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.

Active Medical Devices	Patient monitoring equipment, Electrical therapeutic devices, Medical software (SaMD), Diagnostic imaging equipment
Non-Active Medical Devices	Surgical instruments, Disposable medical consumables, Patient support devices, Wound care products
In Vitro Diagnostic Devices (IVD)	Diagnostic test kits, Analytical testing equipment, Reagents and specimen collection systems
Digital & Connected Medical Devices	Software as a Medical Device (SaMD), Connected healthcare devices, AI-based diagnostic systems

Procedure

• Product definition and Intended Use determination
• Medical device classification
• Establishment of global regulatory strategy (CE, FDA, other markets)
• Implementation and operation of Quality Management System (ISO 13485)
• Risk management implementation (ISO 14971)
• Technical documentation preparation and product testing/verification
• Clinical evaluation or performance evaluation
• Review by regulatory authority or certification body :
  - CE Conformity Assessment
  - FDA 510(k) / De Novo / PMA (as applicable)
• Market authorization and product registration
• Post-Market Surveillance (PMS) and regulatory maintenance

Period for acquisition

Approximately 6–24 months
(May vary depending on device classification, clinical evidence requirements, and regulatory approval processes by country.)

Materials required

• Product description and Intended Use
• Device classification rationale
• Technical Documentation (Technical File / Design Dossier)
• Risk Management Documentation (ISO 14971)
• Clinical Evaluation Report (CER) or Clinical/Performance Data
• Product testing and verification reports
• Software lifecycle documentation (IEC 62304, if applicable)
• Usability engineering documentation (IEC 62366, if applicable)
• ISO 13485 Quality Management System documentation
• Labeling and Instructions for Use (IFU)
• UDI and product registration information
• Post-Market Surveillance (PMS) plan