Drug-Device Combination Products in Oman: FDA & CE Compliance Consulting
Why Drug Device Combination Products Require Expert Regulatory Support in Oman
Drug-device combination products in Oman are regulated healthcare products combining a drug, medical device, or biologic into a single therapeutic solution. These products are complex and require rigorous compliance with FDA 21 CFR Part 4, 21 CFR Part 820, 21 CFR Parts 210 & 211, ISO 13485:2016, and EU MDR (CE Marking) standards.
A well-known example is the drug-eluting stent (DES)—a medical device coated with a pharmaceutical substance to prevent restenosis. Today, combination products also include:
- Prefilled syringes and auto-injectors
- Inhalers and drug-delivery pumps
- Drug-releasing implants
- Advanced applicators and delivery systems
Operon Strategist provides end-to-end consulting services for drug device combination products in Oman, guiding manufacturers through design, development, QMS, CAPA management, and regulatory approval.
Types of Drug Device Combination Products (FDA Classification)
According to FDA 21 CFR Part 4, combination products are classified as:
- Single-entity combination products – a single product containing drug and device components
- Co-packaged combination products – multiple components packaged together
- Cross-labeled combination products – separate components that are labeled for combined use
Common examples: prefilled syringes, topical applicators, inhalers, and injection systems.
Design & Development Requirements for Combination Products in Oman
Proper design control is critical for regulatory compliance. Improper design is a leading cause of FDA Form 483 observations, audit non-conformities, and product recalls.
Manufacturers must comply with:
- ISO 13485:2016 – Quality Management System for medical devices
- 21 CFR Part 820 – Device QSR
- 21 CFR Parts 210 & 211 – Drug GMP
Operon Strategist helps implement robust design control systems, ensuring:
- Safety and efficacy demonstration
- Regulatory audit readiness
- Compliance with FDA, CE, and ISO standards
Combination Product Development Process & Design Control
Drug-device combination products require integration of pharmaceutical and device regulations:
- 21 CFR Parts 210 & 211 – Drug GMP compliance
- 21 CFR Part 820 – Device Quality System Regulation
- 21 CFR Part 4 – Combination Product regulations
Key Documentation Requirements:
- Design History File (DHF) – compiled during design phases
- Device Master Record (DMR) – extracted from DHF for production
- Device History Record (DHR) – records routine manufacturing compliance
- Medical Device File (ISO 13485) – overall regulatory documentation
The complexity of design controls depends on:
- Product complexity
- Intended use
- Risk classification
Our Oman-based regulatory experts ensure full QMS implementation, audit readiness, and faster regulatory approval.
Drug-Device Combination Products as per EU MDR (CE Marking)
Under Regulation (EU) 2017/745 (MDR), integral drug-device combination products fall under Article 1(8) and Article 1(9).
Common Examples of Integral DDCs:
- Single-dose prefilled syringes, pens, and injectors
- Drug-releasing intra-uterine devices
- Dry powder inhalers (non-refillable)
- Implants releasing medicinal substances
- Non-reusable applicators for vaginal or topical use
Non-Integral Medical Devices (Used with Medicinal Products):
- Oral dosing cups and syringes
- Injection needles and filter needles
- Refillable pens and injectors
- Reusable inhalers and spacers
- Drug-delivery pumps
Operon Strategist supports CE Marking for drug device combination products, including Notified Body coordination and technical documentation.
CAPA Management for Drug Device Combination Products
CAPA (Corrective and Preventive Action) management is critical for maintaining compliance of drug device combination products.
CAPA Objectives Include:
- Meeting user needs and intended use
- Ensuring regulatory pathway compliance
- Maintaining reproducible and reliable manufacturing
- Managing post-market risks and complaints
Design Control & CAPA Activities:
- Establish documented design control procedures
- Define design inputs and performance specifications
- Conduct design verification and validation
- Control design changes
- Maintain complete DHF documentation
If your combination product approval is delayed in Oman, request expert review now.
Why Choose Operon Strategist for Drug Device Combination Products in Oman?
- Expertise in FDA 21 CFR Part 820, 4, 210/211, and ISO 13485
- Deep understanding of CE Marking & EU MDR compliance
- Proven success in design control, CAPA, and QMS implementation
- End-to-end support from design to market approval
Accelerate your combination product compliance and market entry with Operon Strategist.
FAQs
What are drug-device combination products?
Therapeutic or diagnostic items combining drugs, devices, or biologics. Examples: prefilled syringes, drug-eluting stents, inhalers.
What regulations apply in Oman?
Manufacturers must comply with DGPA requirements, and globally recognized standards such as FDA 21 CFR Part 4, 820, 210/211, and ISO 13485:2016.
Are combination products subject to CE marking?
Yes, EU MDR Articles 1(8) and 1(9) apply. CE marking is mandatory for integral device components.
What is design control?
A process ensuring products meet user needs and regulatory requirements. Includes inputs, outputs, verification, validation, and DHF maintenance.
Can Operon Strategist assist with registration in Oman?
Yes, we provide regulatory documentation support, QMS implementation, and registration assistance for Omani and international authorities.