Malaysia’s MDA Unveils Guidance on Conformity Declaration Requirements

Malaysia’s Medical Device Authority has revamped the conformity declaration requirements for registering medical devices in the country.

As part of the requirements, manufacturers must attest that their devices comply with the essential principles for safety and performance. Devicemakers also must submit a declaration of conformity, which will be reviewed and confirmed by an assessment body, according to guidance issued last month.

The DoC should contain basic information, such as the manufacturer’s name and address, the device’s name, model, country of origin and risk-based classification, and the name, position and signature of the person who is authorized to complete the document.

The guidance also explains who should sign the DoC. For local manufacturers, the signatory is top management or the responsible person, such as proprietor, president, vice president, director, CEO, managing director or general manager. For foreign manufacturers, it is “any person in the top management category.”

Late last year, the MDA issued draft guidance on conformity assessment procedure for devices that have been approved by recognized foreign regulatory authorities or notified bodies. It explains the requirements to perform a verification process and how the MDA approves conformity assessment certificates (IDDM, Nov. 25, 2015).

The guidance on declaration of conformity follows the release of a document earlier this year on good refurbishment practices for medical devices.

The document names the steps to take when considering refurbishing a medical device, such as its type, configuration, condition, age, upgradeability and phase in its life cycle. The document provides a description of the activities needed to select what medical devices should be refurbished, as well as the information and resources involved in each step.

In addition, the document details the activities and resources needed for dismantling, packaging and transporting these medical devices.

The document notes that some countries have banned the import of used medical equipment, because a number of devices have not been maintained per the requirements of the OEM. “These bans usually fail to distinguish between high-quality refurbishment to the original manufacturer’s specifications and second-hand equipment of undefined quality, with the effect that patients may be denied access to the safe and economical medical device they need,” according to the document.

Read the good refurbishment practice guidance here www.fdanews.com/03-16-MDBGRPMD.pdf and the declaration of conformity guidance here: www.fdanews.com/03-16-MDBDOC.pdf. — Elizabeth Hollis and Jonathon Shacat