Regulatory Support

Establishment License

Section 15(1) of the Malaysian Medical Device Act 2012 (ACT 737) requires a manufacturer, an authorized representative (of a foreign manufacturer), an importer, or a distributor to apply for an Establishment License before it can import, export, or place on the market any registered medical device.

We assist manufacturer, authorized representative, importer or distributor in applying for Establishment License.

Device Registration

Section 5(1) of the Malaysian Medical Device Act 2012 (ACT 737) requires a medical device to be registered with the Medical Device Authority (MDA) before it can be imported, exported, or place on the market.

The manufacturer or authorized representative (of a foreign manufacturer) shall be responsible for registering a medical device through the web-based Medical Device Centerized Online Application System (MeDc@st)

We provide Medical Device Registration on behalf of the manufacturer or authorized representative.

Post Market Support

Section 40 of the Malaysian Medical Device Act 2012 (ACT 737) and Regulation 5 of the Medical Device (Duties & Obligation of Establishments) Regulations 2019 requires an establishment to submit a mandatory problem report to the Medical Device Authority (MDA) when incident relating to the medical device occurred, carry out an investigation to determine the root cause of the incident, and carry out corrective and preventive actions to eliminate or reduce the risk of recurrence.

We provide regulatory support in mandatory problem reporting and field corrective action.

Second-Party Audit

A second-party audit is a valuable tool for strengthening the supply chain through verification if your suppliers/distributors meet or exceed pre-determined requirements. We can conduct a second-party audit on your behalf to ensure the supplier/distributor meeting the quality management system and applicable regulatory requirements.