Regulatory Update | Medical Devices | October 2026 Medical devices are increasingly designed to evolve. Software gets updated, AI models are refined, performance improves, and new capabilities emerge after a device is already on the market. For manufacturers, that raises a critical regulatory question: When does a planned modification require a new submission to the U.S. Food and Drug Administration (FDA)? The FDA is continuing to develop an approach that lets certain anticip

Regulatory Update | Medical Devices | October 2026 Medical-device shortages create serious challenges for healthcare systems, manufacturers, importers, and patients. To strengthen Canada's ability to respond, Health Canada has updated its regulatory framework for device shortages and discontinuations, including new guidance for regulated parties. The update follows amendments to Canada's Medical Devices Regulations published on 17 June 2026; on 16 October 2026, Health Canada

Regulatory Update | In Vitro Diagnostic Medical Devices | October 2026 The European Commission has published a revised version of its guidance on the classification of in vitro diagnostic medical devices (IVDs) under the EU's In Vitro Diagnostic Medical Devices Regulation (IVDR). Published on 9 September 2026, MDCG 2020-16 rev.5 – Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 gives manufacturers and other stakeholders

Regulatory Update | Medical Devices | October 2026 Medical-device market access doesn't end when a product reaches the market. For manufacturers and economic operators, ongoing monitoring of device safety and performance is a core part of the regulatory lifecycle. In Ireland, the Health Products Regulatory Authority (HPRA) continues to oversee this through Field Safety Notices (FSNs), safety communications, and other post-market surveillance activities. On 14 October 2026, th

Regulatory Update | Medical Devices & MedTech | October 2026 The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has set out its regulatory direction for the next five years, with a clear focus on modernising healthcare regulation while supporting innovation and faster access to new technologies. Published on 14 October 2026, the MHRA Strategy 2030 outlines how the regulator plans to respond to rapid advances in science, technology, and global healthcare. For

Regulatory Update | Medical Devices | October 2026 Malaysia's Medical Device Authority (MDA) has introduced further changes to its Product Classification Application System (PCAS) and issued an important update on the validity of Product Classification Letters. Published on 30 September 2026, the announcement confirms that several PCAS enhancements take effect from 1 October 2026. If your company needs to determine whether a product falls within Malaysia's medical-device fram

Regulatory Update | Medical Devices & IVDs | September 2026 Australia's Therapeutic Goods Administration (TGA) has updated its clinical evidence guidance for medical devices and IVDs with a new section addressing computational modelling and simulation (CM&S). Published on 11 September 2026, the update clarifies how manufacturers and sponsors can use in silico methods as part of a device evidence package. It's not a new standalone requirement rather, it's clearer guidance on h

Regulatory Update | October 2026 Singapore is moving toward a more integrated health-regulatory system one that could reshape how healthcare companies, medical-device manufacturers, and other industry stakeholders interact with regulators. On 9 September 2026, Singapore's Health Sciences Authority (HSA) announced that the Health Sciences Authority (Amendment) and Other Matters Bill had been tabled for Second Reading in Parliament. The bill would consolidate health-regulatory

Thailand is reviewing proposed changes to how medical devices are assessed during the authorisation process. On 13 August 2026, the Thai Food and Drug Administration (Thai FDA), through its Medical Device Control Division, published a draft announcement on the criteria, procedures, and conditions for assessing technical documents, analytical testing, establishment inspections, and other examinations used when considering medical-device authorisation. The proposal is part of T

Regulatory Update | September 2026 Indonesia is approaching a major milestone in its halal regulatory framework. From 18 October 2026, mandatory halal certification expands to additional product categories entering and circulating in Indonesia including Class A medical devices. For foreign medical-device manufacturers, this adds a new compliance layer on top of existing registration and market-authorization requirements. What's Changing? Indonesia's halal certification framew

Regulatory Update | August 2026 Malaysia's Medical Device Authority (MDA) has announced a new hologram security label for medical devices adding an extra layer of product identification and security to the country's medical-device regulatory framework. Published on 6 August 2026 via an official press release, Implementation of the Hologram Security Label for Medical Devices, the announcement comes as MDA continues to strengthen oversight across registration, product classific

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