Singapore’s UDI system is fully aligned with international standards and allows direct reuse of compliance credentials obtained from the US and Europe, making it a highly cost-effective market that enables "one-time coding for global multi-market rollout". The Health Sciences Authority (HSA) of Singapore serves as the regulatory authority overseeing the UDI framework, which follows the global harmonisation principles laid down by the International Medical Device Regulators Forum (IMDRF) to reduce manufacturers’ compliance costs. Codes complying with UDI requirements of the US FDA or EU may be applied directly for sales in Singapore without the need for localised dedicated UDI coding. Singapore implements UDI regulations based on risk stratification: mandatory UDI requirements apply only to medium- and high-risk medical devices, while compliance remains voluntary for low-risk products. All UDI data is integrated into the Singapore Medical Device Register (SMDR), enabling streamlined one-stop processing for device registration and UDI submission. HSA adopts a phased rollout strategy, enforcing UDI obligations for one risk classification tier every two years.

This article provides a detailed analysis of the two core licences for medical device registration in Canada: MDEL and MDL. The MDEL, short for Medical Device Establishment Licence, is an establishment access licence. It is mandatory for importers and distributors of all classes of medical devices, as well as manufacturers of Class I medical devices. The MDL, namely Medical Device Licence, serves as a product marketing licence, which is required for manufacturers of high-risk Class II and above medical devices. This paper further elaborates on the required application documents and fee policies for MDEL, and clarifies the licensing obligations and quality management procedures applicable to different market stakeholders.

Boasting a stable regulatory framework and continuously expanding medical demand, Peru’s medical device market has become a key overseas expansion destination for domestic Chinese medical device manufacturers. The core prerequisite to access the Peruvian market is completing official sanitary registration. Peru enforces risk-tiered supervision for medical devices, grouping products into four risk classes ranging from Class I (lowest risk) to Class IV (highest critical risk). Documentation submission requirements vary by risk category. Core mandatory files include the Certificate of Free Sale (CFS), product instructions and labeling, technical & test documentation, and quality management system (QMS) certificates. Post-registration modifications fall into two categories: minor changes and major changes, each subject to distinct handling timelines and compliance requirements.

As a key growth engine of the Southeast Asian medical device market, Indonesia has attracted a large number of Chinese enterprises. Nevertheless, the primary hurdle to entering the Indonesian market lies in its exclusive distributor system. Pursuant to regulations issued by the Indonesian Ministry of Health, overseas medical device manufacturers are obligated to conduct product registration through an exclusive distributor, which serves as a statutory prerequisite for initiating AKL registration. The core rules governing the exclusive distributor system cover three aspects: a sole eligible registration entity, exclusive authorization by product category, and synchronized validity periods for registration certificates and distribution authorizations. This regulatory framework is designed to eliminate cutthroat price competition, standardize unified market strategies and service benchmarks, streamline regulatory communications, and mitigate compliance risks.