Medical Device Registration

🚀 Planning to Register Your Medical Device in Malaysia?

Navigating medical device regulations can be complex, but you don’t have to do it alone.

At KAYV Consulting Services, we provide professional regulatory consulting and compliance support to help manufacturers, importers, distributors, and brand owners meet Malaysian Medical Device Authority (MDA) requirements.

Our Services:
✅ Medical Device Registration (MDA)
✅ Establishment Licence (EL) Application & Renewal
✅ GDPMD Certification Support
✅ ISO 13485 Compliance & Documentation
✅ CSDT File Preparation & Review
✅ Product Classification & Regulatory Strategy
✅ Authorized Representative (AR) Support
✅ Medical Device Advertising Consultation & Compliance Review
✅ Regulatory Gap Assessment & Consultation

🌟 Trusted Regulatory Partner Since 2014
🌟 More Than 12 Years of Industry Experience
🌟 End-to-End Regulatory Support
🌟 Practical & Professional Solutions

Whether you are launching a new medical device, expanding your product portfolio, or ensuring your promotional materials comply with regulations, KAYV Consulting Services is here to support you every step of the way.

📧 [email protected]

Who can register a medical device in Malaysia?

Only companies registered locally in Malaysia with the Companies Commission (SSM) (government authority responsible for company registrations) may apply to obtain an establishment license, register a medical device and apply for an export permit.
Once registered with the SSM, a company needs to create just one account on [email protected]+ from where they apply initially for an Establishment License according to their activity:
Manufacturer’s License, Importer’s License, Distributor’s License or Authorized Representative’s License.
Only companies which have an Establishment License can register a medical device in Malaysia.