Medical Devices

Cisema offers regulatory insight and market access strategy for medical devices in Thailand, Indonesia, and the Philippines.

Learn how Malaysia classifies drug–medical device combination products and how the PMOA determines pathways and compliance responsibilities.

Learn about China's Unique Device Identification (UDI) system and how to navigate China’s evolving medical device market.

Learn about license validity and renewal rules for medical devices in Southeast Asia.

Explore fast-track medical device registration in Southeast Asia, cut timelines by 6–12 months, and accelerate market entry with Cisema.

Learn about Malaysia’s conformity assessment bodies — including CAB evaluation routes, risk classifications, and MDA registration steps.

A complete guide to China hyaluronic acid registration, covering classification, NMPA requirements, and compliance steps for manufacturers.

Learn all about HSA medical device registration in Singapore with timelines, fees, and AR requirements in this step-by-step guide.

Learn how to fast-track medical device registration in ASEAN: timelines, costs, and license options in Malaysia, Singapore, and Vietnam.

This guide explains Singapore’s HSA regulatory system and why it is a strategic first step for entering Southeast Asian markets with medical devices, pharmaceuticals, and cosmetics.

Learn the Malaysia medical device registration process, covering MDA requirements, classification, CAB assessment, timelines, costs, and Authorised Representative roles.

Gain an overview of the medical device registration process in Vietnam with timelines, fees, and Authorized Representative requirements.