To apply for Class A medical device registration in Malaysia, you need to submit your application through the Medical Device Authority (MDA), specifically using the Medical Device Centralized Online Application System (MeDC@St). This is Malaysia's official online portal for medical device registration.

Application Fee: The MDA charges a registration fee, which varies depending on the device type and the applicant’s location (local vs. foreign). Generally, the fees for Class A devices are lower than those for higher-risk categories.

The manufacturer must have a valid ISO 13485 certification, which demonstrates compliance with quality management standards specific to medical devices.

The registration process for a Class A (low-risk) medical device with the Medical Device Authority (MDA) in Malaysia involves several steps to ensure compliance with the Medical Device Act 2012 and the Medical Device Regulations 2012.

Class A medical device registration with the Medical Device Authority (MDA) in Malaysia is the regulatory process required to legally market and distribute low-risk medical devices in Malaysia. Class A devices, considered the lowest risk category under Malaysia’s Medical Device Act 2012, include items such as bandages, non-sterile surgical instruments, and basic diagnostic equipment. The registration ensures these devices meet the standards for quality, safety, and efficacy.

Verify that your product qualifies as a Class A device according to Malaysia's Medical Device Regulation 2012. Class A devices are typically low-risk devices (e.g., surgical instruments, bandages, thermometers).

The typical time to obtain Class I medical device registration with Brazil ANVISA is relatively short compared to higher-risk devices, due to the simplified registration process for low-risk devices.

Class I device registration is generally valid for five years from the date of approval by ANVISA.