Supporting medical devices from classification through registration, TECOLAB ensures regulatory compliance for successful market placement across key global markets, including the EU MDR, US FDA, MDA (Malaysia) and HSA (Singapore). We provide end-to-end support for a broad range of medical devices, including regulatory strategy, technical documentation preparation, and conformity assessment assistance to guide your products through the entire approval process.
Examples of medical devices we support include:Â
Surface disinfectants
Instrument disinfectants
Wound care products
Surgical instruments & accessories
Diagnostic & IVD devices
Providing regulatory support for pharmaceutical products, TECOLAB ensures compliance with key frameworks such as NPRA in Malaysia. We guide your products through dossier preparation, registration, and technical documentation, supporting smooth and compliant approval for a wide range of pharmaceutical products
Examples of pharmaceutical products we support include:
Prescription medicines
Over-the-counter (OTC) products
Antiseptic & therapeutic solutions
TECOLAB provides regulatory support to ensure cosmetic products comply with applicable regulations, helping you with registration in Malaysia and launch with confidence. We assist with product classification, dossier preparation, labeling compliance, and technical documentation for a wide range of cosmetic products.
Examples of cosmetic products we support include:
Hand sanitizers & Hand wash
Skincare products
Perfumes
Other cosmetic products