Abstract

ASEAN MEDICAL DEVICE REGULATIONS: IMPORTS AND EXPORTS WITH RELATED RECALLS AND WARNING LETTERS

D. Satya Phanindra*, M. V. Nagabhushanam, G. Ramakrishna, Sk Sanjuda and M. Beena Devi

Abstract

The ASEAN Medical Device Regulations aim to harmonize standards across the region's 10 member states, ensuring the safety, efficacy, and quality of medical devices while facilitating regional trade. These regulations, guided by the ASEAN Medical Device Directive (AMDD), outline processes for device classification, pre-market approval, and post-market surveillance. In terms of imports and exports, manufacturers and distributors must comply with national regulatory requirements, including product registration and adherence to labeling and safety standards. Mutual Recognition Agreements (MRAs) streamline cross-border trade, reducing regulatory redundancies. Recalls are managed through post-market surveillance systems, addressing safety concerns or non-compliance. Manufacturers and distributors are obligated to report adverse events and execute corrective actions in coordination with regulatory authorities. Warning letters serve as enforcement tools for addressing regulatory violations, such as unauthorized claims, safety lapses, or mislabeling. While ASEAN’s harmonized approach facilitates trade and strengthens regulatory oversight, varying levels of implementation across member states present challenges, requiring manufacturers to navigate both regional and national requirements effectively.

Keywords: ASEAN Medical Device Regulations, ASEAN Medical Device Directive (AMDD), Warning letters, Recalls.