ASTM Certification
What is WHO Certification?
WHO Certification generally refers to the World Health Organization (WHO) Prequalification and Certification Programs, which are designed to assess and recognize the quality, safety, efficacy, and performance of healthcare products and manufacturing facilities. Unlike CE Marking or FCC Certification, the World Health Organization does not issue a universal certification for all products. Instead, it operates specialized evaluation and prequalification programs for health-related products and services.
WHO Prequalification serves as an internationally recognized quality assurance system for products such as pharmaceuticals, vaccines, medical devices, diagnostic kits, and healthcare products. The program helps governments, procurement agencies, international organizations, and healthcare providers identify products that meet globally accepted standards.
Through rigorous assessment, product testing, documentation review, and manufacturing site inspections, WHO ensures that approved products comply with international quality, safety, and efficacy requirements. WHO recognition is particularly valuable for companies seeking access to global healthcare markets and participation in international procurement programs.
Importance of WHO Certification
Global Recognition
Quality Assurance
Market Access
Support for Developing Countries
Enhanced Credibility
Key Documents Required
WHO Certification Process
Document Required
1. Test report
2. Product Dossier
3. User manual of products
4. Factory lieance
5. ISO document of the company
Process
Step1 : Submission of Product Dossier
Step 2: Dossier Review
Step3: Independent Laboratory Testing
Step 4: Site Inspection
Step 5: Prequalification
Conclusion
WHO Certification and Prequalification Programs play a vital role in ensuring the quality, safety, and effectiveness of healthcare products worldwide. Recognition by the World Health Organization enhances product credibility, facilitates global market access, and supports participation in international healthcare procurement programs.
Tekno Engineers India helps manufacturers navigate complex regulatory requirements and achieve international compliance through professional consultancy and end-to-end support. Our expertise ensures a streamlined certification process, enabling businesses to expand confidently into global healthcare markets while maintaining the highest standards of quality and safety.