Regulatory Update | September 2026 For foreign manufacturers eyeing China's feed, feed-additive, or pet-food market, regulatory preparation needs to begin well before the first shipment. A September 2026 regulatory guide from Cisema outlines the requirements for Imported Feed and Feed Additive Registration under China's Ministry of Agriculture and Rural Affairs (MARA) covering product eligibility, technical documentation, local representation, testing, and how MARA registrat

Regulatory Update | September 2026 South Africa's medical-device regulatory landscape is continuing to evolve. The South African Health Products Regulatory Authority (SAHPRA) is advancing work on a more structured regulatory framework with two parallel developments signaling where the market is heading. In August 2026, SAHPRA called for an independent expert review of its Draft Medical Devices Regulations. Then, on 9 September 2026, the Authority published an addendum extendi

Regulatory Update | August 2026 The Egyptian Drug Authority (EDA) has introduced a new registration approach that allows certain medical devices with differences in composition data but the same intended use, medical purpose, classification, and basic design to be registered under a single, unified technical file. Issued by the EDA's Central Administration for Medical Devices on 13 August 2026, the notice gives manufacturers a clearer framework for grouping eligible device c

What’s Changing? Türkiye has introduced a targeted amendment to its Medical Device Sales, Advertising and Promotion Regulation, bringing new requirements for the online sale of contact lenses. Published on 3 July 2026, the amendment strengthens regulatory oversight of online contact-lens sales and clarifies the conditions under which these products may be sold to consumers through digital channels. The update is particularly relevant for: Medical-device companies operating in

What’s Changing? Taiwan’s Food and Drug Administration (TFDA) is introducing two trial measures designed to simplify administrative procedures for medical-device registration, licence changes and renewals. Announced on 25 August 2026, the measures will take effect on 1 October 2026. They focus on: Online review with original documents retained for inspection Ending the issuance of paper-approved copies of medical-device labels, instructions for use and packaging The changes a

What’s Changing? Australia's Therapeutic Goods Administration (TGA) is consulting on proposed changes that would allow it to share more information with the public about medical devices following post-market reviews or investigations. The consultation was published on 13 August 2026 and will remain open until 2 October 2026. The proposal focuses on improving the TGA's ability to communicate information relating to the safety, quality, performance and use of medical devices, p

What’s Changing? Thailand's Food and Drug Administration (Thai FDA) is proposing an update to the rules governing how medical-device authorization applications are assessed. On 13 August 2026, the Thai FDA's Medical Device Control Division published a draft notification concerning the criteria, procedures and conditions for the assessment of technical documents, testing, establishment inspections, and examinations used when considering authorization of medical devices. The dr

What Changed? Hong Kong has updated two key guidance documents governing the listing of medical devices under its Medical Device Administrative Control System (MDACS). On 31 July 2026, Hong Kong's Department of Health, through its Medical Device Division (MDD), updated: GN-02 — Guidance Notes for Listing Class II/III/IV General Medical Devices GN-06 — Guidance Notes for Listing Class B/C/D In Vitro Diagnostic (IVD) Medical Devices The updated guidance took effect on the same

What's Changed? Taiwan is strengthening its regulatory framework for medical devices, with a particular focus on quality management, manufacturing oversight, and distribution practices. On 3 June 2026, Taiwan's Food and Drug Administration (TFDA) published a series of updated medical-device regulations, including regulations covering: Good Distribution Practice (GDP) for medical devices Licensing of medical-device distributors Medical-device quality management systems Inspect

What's Changed? Tanzania is strengthening the use of regulatory reliance as part of its approach to the marketing authorisation of human medicinal products. On 30 June 2026, the Tanzania Medicines and Medical Devices Authority (TMDA) issued a public notice outlining its Regulatory Reliance Pathways for Marketing Authorisation of Human Medicinal Products. The notice was published by TMDA on 3 July 2026. Regulatory reliance allows a national regulatory authority to consider and

In May 2026, the World Health Organisation (WHO) and the African Medicines Agency (AMA) signed a landmark Framework Agreement for Collaboration, establishing a structured partnership to strengthen regulatory systems, promote regulatory reliance and harmonisation, and improve access to safe, effective, and quality-assured health products across the continent. At the same time, the AMA continues to expand its operational role as more African Union Member States ratify the AMA T

What's Changed? On 1 July 2026, Singapore's Health Sciences Authority (HSA) launched a stakeholder consultation on a proposed regulatory framework for Complementary Health Products (CHP) under the Health Products Act. The consultation is open from 1 July to 29 July 2026, inviting industry stakeholders and other interested parties to provide feedback on the proposed regulatory controls. The proposed framework covers a broad range of products, including health supplements, trad

What's Changed? Malaysia's Medical Device Authority (MDA) has introduced a new Automated Re-Registration Route within the MeDC@St 2.0+ platform, marking an important step toward simplifying the renewal of medical device registrations. The MDA announced the new route on 10 July 2026, with the streamlined process becoming effective for eligible applications submitted from 13 July 2026. Applications submitted before this date continue to follow the normal evaluation route. The n

What's Changed? In July 2026, France's National Agency for the Safety of Medicines and Health Products (ANSM) reinforced its expectations regarding medical device vigilance and post-market surveillance, publishing updated guidance to help manufacturers, importers, and economic operators comply with the European Union Medical Device Regulation (EU MDR). The updated guidance highlights manufacturers' responsibilities for reporting serious incidents, monitoring device performanc

What's Changed? In May 2026, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) published the draft Medical Devices (Amendment) Regulations 2026, marking one of the most significant proposed reforms to Great Britain's medical device regulatory framework since Brexit. The draft regulations introduce updated pre-market requirements for medical devices and in vitro diagnostic (IVD) devices, with proposals designed to strengthen patient safety while improving acc

What's Changed? On 1 July 2026, Australia's Therapeutic Goods Administration (TGA) commenced the mandatory implementation of Unique Device Identification (UDI) requirements for higher-risk medical devices, beginning with Class IIb and Class III devices. The new requirements are designed to improve the identification and traceability of medical devices throughout their lifecycle, supporting stronger post-market surveillance, faster safety actions, and greater transparency acro

What's Changed? On 17 June 2026, Health Canada announced Phase 2 of its Medical Device Establishment Licence (MDEL) modernisation, introducing updated regulations and revised guidance aimed at strengthening Canada's medical device regulatory framework. The amendments, which will take effect on 14 December 2026, are intended to reduce unnecessary regulatory burden while improving regulatory clarity, transparency, and oversight. Among the key changes are revised licensing requi

What's Changed? On 19 May 2026, Mexico's Federal Commission for the Protection against Sanitary Risks (COFEPRIS) published the final version of NOM-137-SSA1-2025, the country's updated labelling standard for medical devices. The new standard introduces important revisions to labelling and Instructions for Use (IFU) requirements, updates key regulatory definitions, clarifies manufacturer responsibilities, and aligns several provisions more closely with internationally recognis

What's Changed? On 12 June 2026, Brazil's National Health Surveillance Agency (ANVISA) announced additional support measures as the country transitions to the Declaração Única de Importação (DUIMP), Brazil's new Single Import Declaration system. Since 27 April 2026, DUIMP has become mandatory for many import operations requiring ANVISA authorisation, replacing the previous Import Licence (LI) and Import Declaration (DI) processes. The new model centralises customs, fiscal, co

Regulatory Update The Philippine Food and Drug Administration (FDA) continues advancing its digital transformation agenda through the expansion of its FDA eServices Portal, reinforcing its commitment to improving the efficiency, accessibility, and transparency of regulatory services. By encouraging regulated companies to submit applications and manage regulatory transactions through digital platforms, the FDA aims to streamline interactions with industry while supporting a mo