This article systematically introduces the key regulatory points for medical device market access in Peru, covering the regulator DIGEMID and its legal framework (including Ley 29459, DS-016-2011-SA, etc.), as well as the four-tier risk classification system aligned with IMDRF. There is no equivalence-based simplified pathway, and standard technical review is mandatory for all risk classes. Registration types include New Registration (Inscripción), Renewal (Reinscripción) and Exceptional Import (Autorización Excepcional). Notably, Peru charges the lowest official fees among the three Latin American jurisdictions: Peru, Colombia and Mexico. It also clarifies that overseas manufacturers must appoint a local Peruvian Droguería or Laboratorio as the registration holder, and highlights practical details such as electronic submission via the VUCE system, 5-year validity of sanitary registration certificates, and exemption from clinical reports for Class III / IV devices during renewal.

This article systematically analyzes the regulatory framework for medical device market access in Mexico, covering the competent authority (COFEPRIS), primary legislation and supporting standards (LGS, RIS and NOM series). It highlights the key 2026 reform that extends the registration validity period from 5 years to 10 years upon renewal. It introduces Mexico’s distinctive three-tier risk classification system (Class I / II / III; IVDs are not classified independently, while high-risk IVDs are directly assigned to Class III), clarifies that not all Class I devices are exempt from registration, and describes the transition period starting in 2025 under which certain previously exempt products become subject to mandatory registration. It elaborates on the three registration pathways: the conventional standard pathway, the RELIANCE equivalence review pathway (which accepts approvals from IMDRF member jurisdictions including FDA, CE and China NMPA, though full compliance with Mexican local requirements is mandatory), and the simplified pathway for low-risk devices. It also addresses core requirements including local representation, technical documentation, change management and post-market surveillance, aiming to deliver practical guidance for Chinese enterprises seeking efficient access to the Mexican market.

This article systematically sorts out key practical points for medical device market access in Colombia. It focuses on the INVIMA regulatory framework, the four-tier risk classification system aligned with IMDRF, and the dual-track pathways of automatic registration and technical review. Automatic registration applies to Class I/IIa medical devices and Class I/II IVD products. Approval can be granted within 2 working days, yet this pathway is not exempt from review; post-hoc verification and supplementary document requests may be issued afterward. High-risk products (Class IIb/III and Class III IVDs) must undergo review by the specialized technical committee. The statutory review period is 90 working days, with only one round of supplementary submissions allowed, leaving extremely limited room for error. The article also covers full life-cycle requirements including regulatory basis, classification rules, document checklists, variation and renewal procedures, plus post-market surveillance. It aims to help Chinese medical device manufacturers enter this core Latin American market efficiently and in full compliance.

This article, based on content from the CMEF open class, systematically analyzes the key procedures and common risk points for the registration of high-risk medical devices (Class III/IV) in Japan. It covers Japan’s four-tier medical device risk classification rules, the requirement that overseas enterprises must appoint a Japanese MAH or D‑MAH as the legal marketing authorization holder, Foreign Manufacturer Registration (FMR), and the prerequisite of ISO 13485 quality system compliance. It also highlights the impact of accurate classification determination on the application pathway, document preparation and project timeline. It notes that some Class II products also require PMDA approval instead of only third‑party certification, and all high-risk products are subject to multiple rounds of formal PMDA consultations and technical reviews.