Malaysia Updates Enforcement Date for Medical Device Import Permit

On 1 December 2025, the Medical Device Authority (MDA) of Malaysia announced an update to the enforcement timeline for the country’s Medical Device Import Permit requirement.

The enforcement, originally scheduled to take effect on January 2, 2026, has now been postponed to July 1, 2027.

This extension gives industry stakeholders additional time to prepare for full compliance with the new import control framework under the Customs (Prohibition of Import) Order 2023.

The Medical Device Import Permit regime aims to strengthen Malaysia’s regulatory oversight of medical devices entering the country. Under the Customs Order, medical devices are subject to import permit requirements, and the MDA is the designated Other Government Agency (OGA) responsible for issuing these permits.

Until 1 July 2027, importers will continue to follow the existing customs declaration procedures when bringing medical devices into Malaysia. The postponement is intended to support a smooth transition and help affected parties adjust internal processes and systems to meet the requirements of the forthcoming permit regime.

To facilitate early preparation, the MDA also highlighted that from 1 June 2026, stakeholders may voluntarily submit Verification Slip applications for non-medical devices that fall under medical device tariff codes via the ePermit online system.

This voluntary step allows importers to familiarise themselves with the permit platform and submission process well ahead of mandatory enforcement.

The decision to postpone the enforcement date reflects a recognition of the complexities involved in implementing a new national import control mechanism. Many businesses will need time to register users, adapt standard operating procedures (SOPs), and integrate permit applications into their customs workflows without disrupting supply chain operations.

For regulatory and compliance teams, this change underscores the importance of proactive planning. Importers should use the extended timeline to review product portfolios, determine which tariff codes apply, and ensure they are ready to transition to the import permit system by the new enforcement date.

In addition, organisations may consider building internal training programmes to familiarise logistics personnel and regulatory affairs teams with the ePermit system, verification slip procedures, and any associated documentation requirements.

The extended enforcement date also provides an opportunity for distributors and authorised representatives to align their compliance strategies with broader regulatory developments in Malaysia’s medical device regulatory framework. With the enforcement now set for mid-2027, companies can phase in changes gradually while maintaining uninterrupted import operations.

Overall, the MDA’s update on the enforcement timeline offers the industry valuable breathing space to prepare for one of the most significant changes in Malaysia’s medical device import regulation in recent years. Monitoring ongoing updates and preparing for full compliance should remain a priority for all affected stakeholders.

Source: Medical Device Authority (MDA), Ministry of Health Malaysia.