Medical Devices – Europe, South America, Asia, MENA and ROW Regulatory News – Oct 2026

Algeria

Consultation Notice No. 14-2026: Acquisition of Spare Parts for Laboratory Equipment (Oct 21st 2026)

National Agency for Pharmaceutical Products (ANPP) acts as Algeria’s regulatory authority ensuring the quality, safety, and compliance of pharmaceutical products and medical devices. The notice explicitly targets the procurement of specialized maintenance components and spare parts required to service, calibrate, and maintain the complex scientific machinery inside the agency’s quality control and testing laboratories. Bids must be submitted no later than the final submission deadline of November 3, 2026, at 12:00 PM. Bidders shall remain bound by their bids for a period of 90 days from the submission deadline.

Argentina

ANMAT establishes new guidelines for processing Good Manufacturing Practices (GMP) certificates abroad (October 6, 2026)

ANMAT has introduced new guidelines for obtaining Good Manufacturing Practice (GMP) certificates for overseas manufacturers of medical devices and in vitro diagnostic products. The new framework standardizes documentation requirements and introduces a uniform certificate format. It outlines evaluation timelines, risk-based assessments, and requirements for certification renewal and scope expansion. The measure aims to strengthen regulatory convergence, reduce duplication, and streamline certification procedures. These changes support timely access to safe, high-quality medical products in Argentina.

Austria

Round-table discussion on certificates of free sale for medical devices (October 22, 2026)

Austrian industry associations and regulatory authorities recently held a round-table discussion to streamline the application process for certificates of free sale (CFS) under EU regulations. Participants focused on improving communication, enhancing status transparency, and minimizing avoidable formal deficiencies in applications. To optimize procedures, stakeholders proposed developing practical guidance and increasing dialogue on handling extensive submissions. These insights will help refine workflows between applicants and authorities while expanding collaboration with European bodies.

Egypt

EDA Participates in “MedDevReg AfriSummit 2026” ( 01 October 2026 – 02 October 2026)

The Egyptian Drug Authority (EDA) participated in the sixth edition of MedDevReg AfriSummit 2026, held on October 1–2, 2026, to share Egypt’s experience in medical device regulation and evaluation. The Authority highlighted updates to regulatory procedures, product registration, import approvals, and digital transformation initiatives. Discussions also covered risk-based device classification, Software as a Medical Device (SaMD), and AI-based medical technologies. EDA emphasized regulatory harmonization, digital traceability, and cooperation among African regulatory authorities to strengthen post-market surveillance and reduce procedural duplication. The participation reinforces Egypt’s commitment to improving regulatory convergence and facilitating access to safe medical devices across Africa.

Public Consultation for Procedures and Rules Regulating Amendments to Registration Notification Data of Imported Medical Devices Holding International Quality Certificates (18 October 2026)

The Egyptian Drug Authority (EDA) has announced a public consultation on the fourth edition of its regulatory guideline governing amendments to registration notification data for imported medical devices holding international quality certificates. The consultation invites stakeholders to submit comments and proposals to support the refinement of regulatory procedures. Feedback can be submitted through the designated stakeholder feedback form or via email to the EDA. The consultation commenced on 19 October 2026 and will remain open for 10 working days. This initiative aims to enhance regulatory clarity and ensure efficient management of medical device registration amendments in Egypt.

Indonesia

Halal Requirements for Risk Class A Medical Devices (17 October 2026)

Indonesia’s halal certification requirements for Risk Class A medical devices take effect from 18 October 2026, following the end of the transition period on 17 October 2026. Manufacturers should assess product applicability, materials, and manufacturing processes to ensure compliance with Indonesian regulations. Devices containing non-halal materials may remain eligible for distribution, subject to applicable disclosure and marking requirements.

Kenya

Strengthening Medical Device Regulation Across Africa (October 19, 2026)

Africa is making steady progress toward harmonized medical device and IVD regulation through frameworks like the African Medicines Regulatory Harmonization (AMRH) Initiative, African Medical Devices Forum (AMDF), and the African Medicines Agency (AMA). These were highlighted by Dr. Pauline Wairimu, Head of Medical Devices at the Pharmacy and Poisons Board (PPB), at Afri Summit 2026, which was held on Oct 1, 2026. While regulatory fragmentation and post-market surveillance remain hurdles, leaders emphasize that digital expansion and local manufacturing are vital. These concerted efforts aim to strengthen continental regulatory capacity and ensure sustainable oversight. Ultimately, this collaboration is essential for improving patient access to safe, quality-assured medical technologies across africa.

Nigeria

Importing medical equipment into Nigeria: NAFDAC registration and NAPAMS (20 October 2026)

Medical devices in Nigeria cannot be imported or sold without prior registration under the National Agency for Food and Drug Administration and Control (NAFDAC) Act, applicants must use NAPAMS portal, one per product, product group or family. The maximum processing time spanning from 120 to 240 working days is different for each device class. Overseas manufacturers must secure mandatory documentation, including a notarized power of attorney and a GMP inspection letter, well in advance.

This is because registration is product-specific and entirely separate from Standards Organisation of Nigeria Conformity Assessment Programme (SONCAP) obligations, foreign suppliers must factor these extensive timelines into their planning.

Singapore

Premarket Submission Checklist for Medical Device Product Registration Submission (01 Oct 2026)

Singapore’s Health Sciences Authority (HSA) has introduced the Premarket Submission Checklist for Medical Device Product Registration Submission (MD-01 R1), effective from 1 October 2026. The checklist is mandatory for specified Class B, C, and D medical devices registration pathways and aims to improve dossier completeness and submission readiness. Applicants should ensure that all applicable administrative, technical, and supporting documents are complete before submission.

Sri Lanka

Reporting of Adverse Events related to Medical Devices including In Vitro Diagnostics (01 Oct 2026)

Sri Lanka’s National Medicines Regulatory Authority (NMRA) has issued a clarification regarding STRATLINK/ASYCUDA clearance requirements. When the actual shipper or supplier differs from the manufacturer stated on the Registration Certificate, a manufacturer-issued Letter of Authorization must be uploaded to the system to facilitate clearance and ensure regulatory compliance.

Taiwan

Application Guidelines for Clinical Trial Proposals for Medical Devices (05 Oct 2026)

Taiwan Food and Drug Administration revised its guidelines for Medical Device Clinical Trial Applications, effective from 5 October 2026, to reflect electronic submission procedures and updated application forms. The revised guidance replaces the previous 2021 version and covers clinical trial applications, amendments, progress reports, and final reports. Sponsors should review the updated documentation requirements and use the designated digital platform for submissions.

Tanzania

Payment of Annual Retention Fees for the Year 2027 (Oct 01, 2026)

The Tanzania Medicines and Medical Devices Authority (TMDA) announced that product retention proforma invoices for registered medical products, devices, and IVDs will be issued via portal accounts by October 2026. Marketing Authorization Holders (MAHs) must review these and submit their active product lists by November 1, 2026, with retention fees payable penalty-free until January 31, 2027. Payments made between February 1 and March 31, 2027, will incur regulatory penalties. Non-declared products or those with pending fees will face import permit blocks and registration suspension by April 1, 2027, leading to automatic revocation if unresolved within 12 months.

Notice on Submission of Biennial Post – Marketing Surveillance (PMS) Reports for Medical Devices and In Vitro Diagnostics (October 5, 2026)

Tanzania Medicines and Medical Devices Authority (TMDA) reminded all medical device and in vitro diagnostic (IVD) applicants and companies of their mandatory requirement to submit biennial Post-Marketing Surveillance (PMS) reports. Applicants must ensure ongoing product safety and compliance, as failure to submit these required reports will lead to strict regulatory penalties.

United Arab Emirates (UAE)

Medical device Rilefast CE Drops Registered in the UAE (12 October 2026)

Gruppo Farmaimpresa (an Italian CDMO) has announced the registration of Rilefast CE oral drops in the United Arab Emirates (UAE), marking another milestone in its international market expansion. Rilefast CE is a medical device formulated with simethicone in olive oil, intended to relieve gastrointestinal gas-related symptoms, including bloating, cramps, and colic. The product is designed for use in infants, children, and adults. This registration strengthens Gruppo Farmaimpresa’s presence in the Middle East and creates opportunities for broader market access and distribution.