Pure Global Editorial Team

Two early FDA Warning Letters from post-effective QMSR inspections directly cite incorporated ISO 13485:2016 clauses. The cases connect risk management to design changes, intended use, suppliers, complaints, rework, CAPA, environmental controls, and software validation—and give manufacturers a concrete evidence map for inspection readiness.

Two EU delegated regulations expand separate MDR exemptions for specified well-established technologies. The changes affect clinical-investigation decisions for listed implantable and Class III devices and per-device technical-documentation assessment for listed Class IIb implants, without removing broader MDR evidence or conformity-assessment duties.

Final IMDRF N90 defines five principles and three connected elements for medical device software PCCPs. It creates a common design framework, not automatic authorization: manufacturers must still verify acceptance, scope, and implementation requirements in every market.

The Malaysian Ministry of Health (MOH) and Medical Device Authority (MDA) announced the phased implementation of a Hologram Security Label for registered medical devices. The initiative aims to strengthen post-market surveillance, improve product traceability and help medical device and IVD manufacturers, healthcare professionals and consumers identify registered products and combat counterfeit and unregistered medical devices.

MDCG 2026-4 sets out the transition from notified-body to manufacturer uploads of SSCPs and SSPs in EUDAMED, including interim responsibilities, planned system milestones, and a 27 February 2027 date for pre-mandatory-use devices.

FDA's FY 2027 medical device fees apply from October 1, 2026 through September 30, 2027. Most submission fees rise about 9.9%, while annual establishment registration rises 20.7% to $13,785. This update compares every FY 2027 standard and small-business rate with FY 2026 and shows the impact on common filing budgets.

India's CDSCO has issued a 62-page Medical Device Software guidance under MDR 2017. It maps intended-use classification, portals, licensing authorities, dossier evidence, QMS and software-lifecycle controls, cybersecurity, AI change planning, and post-market obligations while expressly stating that it does not create a new regulatory control.

Sri Lanka's NMRA has classified specified aesthetic implants, fillers, invasive fat-removal products, energy-based platforms, and microneedling devices as Class IIa, IIb, or III. The notice grants a registration grace period until July 23, 2027 and requires manufacturers to segment portfolios by technology rather than use one blanket aesthetic-device class.

Pure Global COO DJ Fang explains how AI streamlines medical device compliance, accelerates regulatory documentation, and supports global market access.

The European Commission updated its consolidated list of links to Notified Body standard-fee schedules on 13 July 2026. The list helps medical device and IVD manufacturers access published certification fee information for budgeting and Notified Body selection.

MDCG 2026-5 confirms that UDI-DIs must remain linked to the manufacturer in private-label and distributor-brand arrangements. Manufacturers retain legal responsibility for UDI assignment, maintenance, and EUDAMED registration, even when practical activities are delegated.

The World Health Organization recognized Brazil’s ANVISA as a Transitional WHO Listed Authority for Medical Devices (tWLAs-MD) on 1 July 2026, acknowledging its regulatory oversight of medical devices and IVDs. The designation supports WHO’s transition to the WHO Listed Authorities framework, promoting international regulatory reliance and confidence in ANVISA’s decisions.

The Malaysia Medical Device Authority (MDA) announced that Product Classification Applications will transition to a fully online submission process effective 1 August 2026. The new Product Classification Application System is intended to streamline classification requests, improve regulatory efficiency, and support Malaysia’s digital transformation of medical device regulatory services.

ANVISA hosted a technical exchange with Chile’s ISP in July 2026 to strengthen medical device regulatory cooperation. The initiative covered Brazil’s regulatory framework, including registration, GMP certification, inspections, import controls, and post-market surveillance, supporting regulatory convergence and best practice sharing across Latin America.

Mexico has published the COFEPRIS Medical Device Registration Guidance 2026, providing the first comprehensive instructions for preparing registration dossiers under the Equivalence Agreements and Abbreviated Regulatory Pathway. The guidance clarifies expectations for administrative, quality, technical, clinical, and post-market surveillance documentation, with a strong emphasis on document consistency, manufacturing traceability, Spanish-language compliance, and risk-based evidence.

MDA's MeDC@St 2.0+ Automated Re-Registration Route allows eligible medical device registration holders to renew registrations through an automated process. Applications must be submitted within one year before expiry, as expired registrations require a new registration under the Medical Device Act 2012 (Act 737).

Malaysia's MDA and China's NMPA have launched Pilot Phase 2 of the Malaysia-China Joint Evaluation Pilot Programme, open from 1 July to 30 September 2026. The programme enables simultaneous evaluation of eligible medical devices under the GHWP CERP framework to reduce duplicative review and support faster access to both markets.

The Philippine Department of Health has extended the suspension of higher medical device registration fees for another 120 working days from 2 June 2026, keeping CMDR applications under the current lower government fee schedule while Administrative Order No. 2024-0016 remains suspended.