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Medical Device Regulatory Compliance

Aesthetic & Designated Medical Device Registration

Are you importing, supplying or distributing aesthetic devices in Malaysia?

From 1 June 2026, certain aesthetic devices fall under Malaysia's Designated Medical Device regulatory requirements.

New Regulatory Requirement Effective from 1 June 2026
Aesthetic Medical Device Regulatory Compliance
Aesthetic Medical Devices Regulatory assessment, documentation & registration support
Product Assessment

Is Your Aesthetic Device Affected?

Certain aesthetic equipment may fall under the Designated Medical Device requirements depending on its technology, intended use and application.

Hair Removal
Skin Rejuvenation
Pigmentation Treatment
Wrinkle Reduction
Body Contouring / Slimming
Other Aesthetic Applications
  Not sure whether your device is affected? We can assess your product before you proceed.
Regulatory Support

What Do You Need?

Depending on your company's activities and the device, you may require the following regulatory support.

01

GDPMD Certification

GDPMD (Good Distribution Practice for Medical Devices) is a quality management requirement applicable to certain establishments involved in the medical device supply chain.

Documentation & Audit Preparation
02

MDA Establishment Licence

Companies acting as an Authorized Representative, Importer and/or Distributor may require the appropriate Establishment Licence.

Application & Supporting Documents
03

Designated Medical Device Registration

Your designated medical device may need to be registered with the Medical Device Authority (MDA). We support document assessment, preparation and submission.

CSDT & Technical Documentation
Special Promotional Package

Complete Regulatory Support for Aesthetic & Designated Medical Devices

One package to help you get your company and product ready for Malaysian regulatory compliance.

GDPMD Consultation & Documentation
GDPMD Audit Preparation
Establishment Licence Application Support
1 Designated Medical Device Registration
CSDT Preparation & Technical Documentation Review
MDA Submission Support
Promotional Package RM12,000
Medical Device Regulatory Consulting
End-to-End Support

Medical Device Regulatory & Compliance Services

From regulatory assessment and GDPMD documentation to establishment licensing and product registration — we guide you throughout the process.

Ready to Assess Your Medical Device?

Contact us today for an initial assessment of your Aesthetic or Designated Medical Device.

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Terms and conditions apply. Package eligibility is subject to product and company assessment. Government, CAB, certification, testing and other third-party fees are excluded unless specifically stated in the quotation.