How can a company get ISO 13485 Certification in UAE?
- ISO Certification
- Jun 3, 2025
- 3 min read
What is ISO 13485?
ISO 13485 Certification in UAE is a globally accepted standard created to help anyone working with medical equipment. It offers rules for the advancement of the creation of a Quality Management System (QMS), which ensures that the item and administrations meet the requests of the clients as well as the directions all through the whole lifecycle that the thing is in utilize. Unlike generic quality standards, ISO 13485 focuses heavily on risk management, traceability, sterile environments, and regulatory documentation–making it essential for companies dealing with healthcare products.
Why ISO 13485 Certification is Crucial in the UAE
The UAE healthcare industry is growing because of Vision 2031 and increased government investment. With this increase comes greater regulation and scrutiny. Ministries such as MOHAP, DHA, and SEHA need strict compliance when it comes to the importation, manufacturing, distribution, or manufacturing of medical devices. Here’s why ISO 13485 certification is crucial to the UAE:
The requirement registration is required for MOHAP the registration of medical devices
You can be sure that your products are worldwide.
Facilitates exports to EU, GCC, and North America
Increases safety for patients and the trust of brands
Reduces the chance of product recalls and legal sanctions
Benefits of ISO 13485 Certification in UAE
Regulative Adjustment: ensure compliance in accordance with UAE laws on health and aid in product registration.
Market expansion: ISO 13485 is typically the minimum requirement for selling on international markets.
Risk Reduced: Better processes reduce recalls, errors and non-compliance concerns.
Trust in the Customer: Healthcare facilities, clinics, and institutions of government trust ISO-certified suppliers.
Operational Control: Standardized processes improve efficiency and reduce the amount of waste.
Audit Ready: Easy to be able to pass audits of MOHAP or other foreign regulatory bodies (e.g., CE, FDA).
Industries That Require ISO 13485 Certification in UAE
Manufacturers of medical devices
Services for sterilization
Medical device importers/distributors
Software for monitoring health
Production or contract research companies
Diagnostic and surgical equipment kit suppliers
No matter if you’re based in Dubai, Abu Dhabi, or Sharjah, ISO 13485 consultants in UAE applies when you work with medical equipment or other technology.
How ISO 13485 Certification in UAE Supports MOHAP Registration?
To be able to register a medical device to the UAE through the Ministry of Health and Prevention (MOHAP), the company must submit:
Current ISO 13485 certificate
CE Marking or FDA Approval
Technical file for the product
Data on performance and safety
ISO 13485 lays the foundation for the documentation MOHAP needs, ensuring quicker approvals and fewer compliance issues.
Maintaining ISO 13485 Certification in UAE
After getting the certification:
You are required to undergo regular surveillance audits
Maintain up-to-date documentation
Conduct regular internal audits and management reviews.
The certificate lasts and is valid for three years, following which renewal is required.
Cost of ISO 13485 Certification in UAE
The cost is based on:
The size of the company and the number of employees
Scope of the QMS
A certification body has been selected
Consulting and documentation needs
The cost will vary between AED 15,000 to 50k+. The cost of consulting may be distinct.
How to Get ISO 13485 Certification in UAE
1. Gap Analysis: Find out what your current processes do not meet in comparison to ISO 13485 Consultants in UAE standards.
2. Planning and team setup: Define your responsibilities, define deadlines, and establish your objectives for certification.
3. QMS documentation: Develop Quality Manual SOPs, SOPs, risk plans and compliance documentation.
4. Application: Use the QMS for the design, production and delivery of products.
5. Instruction: Inform personnel of ISO 13485 requirements, documentation and procedures.
6. Internal Audit: Verify that your system functions. Resolve any nonconformities by taking corrective action.
7. Management Review: High-level meeting to discuss audit results and overall performance of the system.
8. Stage 1 Audit: The certification body reviews your documentation for compliance.
9. Stage 2 Audit: Audits on site to ensure the proper that the QMS is being implemented. QMS.
10. Certificate The certificate was issued: You will receive an ISO 13485 certificate (valid for 3 years and yearly audits).
Why Factocert for ISO 13485 Certification in UAE
We provide the best ISO 13485 Certification in UAE who are knowledgeable and provide the best solutions. Kindly contact us at contact@factocert.com. ISO 13485 Certification consultants in UAE and ISO 13485 auditors in UAE work according to ISO standards and help organizations implement ISO 13485 certification consultants in UAE with proper documentation.
For more information, visit ISO 13485 Certification in UAE.
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