Mozambique medical device regulations

Implementation circular signed on 20 August 2025 announcing implementation on 5 January 2026 of the device/IVD marketing-authorisation manual, with registration for priority-list products and notification for other products. The priority-list annex is referenced separately from this one-page notice.

Official Gazette decree approving security requirements for Category 1–3 radioactive material, including teletherapy, gamma-knife and high- or medium-dose brachytherapy sources listed in Annex II. Covers notification and authorisation, maintenance and replacement, transfers and transport, incident reporting, inspection and the regulator’s powers over authorisations. The regulation and its four annexes retain the source’s specific industrial and worker-security provisions. Decree Article 3 provides for commencement on publication on 26 December 2023. Later amendments and current applicability remain under review.

Approves radiation-source and radioactive-installation licensing and inspection rules, expressly covering medical uses, radiotherapy, diagnostic and interventional radiography, and nuclear medicine. The regulation addresses registration and licences for activities including import, use and transport; licence conditions, modification, renewal, facility classes, inspections, fees and seven annexes. Licence modification is tied to changes in the conditions listed in Article 10. The 15- or 30-working-day licensing periods apply to a duly completed application, depending on whether inspection is required. Annex VII states inspection frequencies per year, with an explanatory footnote. These are specialised ionising-radiation controls, rather than a general MD/IVD marketing-authorisation procedure. The decree takes effect on publication on 15 August 2023; its printed Council approval date is 6 December 2022. Later amendments and currentness remain unverified.

Decree and incorporated Regulation governing marketing authorisation and subsequent changes for health products, explicitly including medical devices and IVDs. Includes the glossary annex and the provisions on variations, renewals, labelling, fees and implementing instructions.

Original Gazette decree approving the Regulation on Radiation Protection and seven annexes. It directly covers medical radiological equipment, radiation sources and associated software, including justification and optimisation of medical exposure, calibration, acceptance and commissioning, quality assurance after important maintenance or software changes, accidental exposure investigation and patient-discharge controls. The complete regulation also provides the necessary source-notification and authorisation, safety-assessment, inventory, supplier, transfer, inspection and enforcement context. Industrial, occupational, consumer-product and emergency provisions retain their own stated scope; this is not a general MD/IVD marketing-authorisation regulation. Approved on 10 July 2018 and published on 21 August 2018; decree Article 3 starts the Regulation on publication. Source printing anomalies in the glossary and numerical annexes are retained literally with page-image evidence rather than corrected from external standards. Annex VII contains penalties, while the final page shows the Gazette copy price. Later amendments, updated penalty amounts and current applicability remain unverified.

Official Gazette decree fixing radiation licensing and service fees, with complete Annexes I and II. Medical rows cover radiotherapy, diagnostic and dental X-ray, CT, nuclear medicine and unsealed radioactive sources, including specified installation registration, use, import, export and inspection charges in Meticais. The Validade column records licence validity; the 30-day period in Article 2 is a payment deadline after a favourable licence notification. Article 3 exempts activities and practices of the National Health Service. Article 5 authorises later fee updates by a joint ministerial diploma for Finance and Atomic Energy. Industrial, security and mineral rows are retained as annex context and keep their own scope. Approved on 3 April 2018, published on 24 April 2018, and commenced on publication under Article 6. These radiation charges do not establish general medical-device or IVD marketing authorisation or variation fees. Subsequent rate amendments and present applicability remain unverified.

Atomic Energy Law establishing the framework for peaceful uses of nuclear energy and ionising radiation. Its express scope includes sources for medical purposes, radiation-producing devices and mobile radiography equipment. It creates the national regulator and covers prior licensing, changes to licensed activities, source inventories and transfers, renewable licences of up to five years, inspection and enforcement, medical practices and patient protection, radioactive-source imports and exports, loss and accident notification, waste management and emergency planning. The complete 77 articles and incorporated glossary are retained, including their nuclear-security and civil-liability context. Its medical relevance concerns regulated radiation practices and equipment; it does not establish general medical-device or IVD marketing-authorisation procedures. Approved on 9 May 2017, promulgated and published on 21 July 2017. Article 77 provides commencement 90 days after publication. Later amendments, implementation and current applicability remain unverified.

General MD AIM dossier checklist:administrative, product description, nonclinical, clinical, labelling andQMS chapters. Mandatory markings, blank cells and endnotes are preserved together. Finalnotes exempt Chapter4 presentation for source-defined generic devices and state Chapters4and6submission is not mandatory for ClassB; these do not establish exemption from every underlying safety/evidence obligation. ManualAnnexIII row parity, standalone version authority and current amendments remain unresolved.

MD/IVD collaborative/recognition dossier checklist:Chapters1,2and5, with X, X se aplicável and ellipsis legend preserved. Requires the same TechnicalFile/STED submitted to the recognized reference entity, plus WHO collaborative appendices where relevant. Blank table cells are not inferred to be optional. Printed blank2025signature fields do not establish issuance or commencement; standalone/manual version authority remains open.

Official-linked ANARME-branded English template covering device/IVD safety and performance, evidence, clinical evaluation, labels, implants and software. Preserve conflicting source clauses:13.1(3),13A.4 and13B require English;13.4(2) uses ClassI/ClassIIa/Class1IVD, unlike the local Portuguese/A–D framework. Exact template text is retained for consultation; this is not an established override of Decree19/2023 Article10 or proof of locally applicable classifications. Incorporation, current version and these conflicts remain unresolved.

Complete four-page rendered standalone Office renewal checklist for MD/IVD AIM. Its31coded requirements correspond to manualAnnexVpages148–151; it adds product/applicant and signature fields. It is an alternate source expression, not31new obligations or a separately enacted regulation. Source spellings and the chapter jump2to5 remain unchanged. Printed blank2025signature fields are template content, not an issue/effective date. Standalone/manual authority, later versions and currentness remain unverified.

Complete 158-page authority manual for medical-device and IVD marketing authorisation, including classification, applicants, dossier submission, post-authorisation acts, labelling, fees and timelines, forms and technical annexes. The original document identifies version 00. No publication or effective date is inferred from the download URL.

Simplified MD/IVD reception/validation checklist with administrative, product, labels/IFU, chemical, performance, risk and safety/effectiveness sections. Body cites Decree19/2023. Whether this is an older, alternative or superseded expression relative to the158page manual and longer standalone checklists is unresolved. No supersession, publication or commencement is inferred from filename, document properties, upload path or retrieval date.

IVD AIM dossier checklist covering analytical/clinical performance, specimens, traceability, stability, software, labels andQMS. Source-specific mandatory, conditional and optional markings and blankcells are retained. Finalnotes exempt Chapter4presentation for source-defined generic devices and state Chapters4and6submission is not mandatory for ClassBIVDs; no blanket underlying safety/evidence exemption is inferred. ManualAnnexIV parity, standalone version authority and current amendments remain open.

ANEA guide for licensing and operation of providers of external individual and area radiation monitoring, including services for hospitals and clinics. It implements the authorised dosimetry-provider requirement cited from Decree 49/2018 Article 29(3). The complete guide covers domestic and foreign providers, the licensing dossier, a two-year licence, renewal requested at least 90 days before expiry, licensing-file characteristic changes reported within 30 days, cessation and dose-record handover, facilities, staff, quality assurance, monitoring and readout intervals, dose reporting, confidentiality, calibration and the dosimetry annex. These are occupational radiation-monitoring provider requirements, not general medical-device or IVD product authorisation or variation rules. Proposed provider honorários are not government tariff rates. The approval page is signed and dated 14 November 2025; the 2026/06 upload path is not a legal adoption or commencement date. Source numbering, index discrepancies and literal unit/formula anomalies are retained. Later revisions and present applicability remain unverified.

ANEA request-letter template for a company to join its laboratory external individual dosimetry service for occupationally exposed workers. The complete one-page template retains company, address, NUIT, date, signatory and position placeholders and lists the application form and worker identification and curriculum vitae attachments. Its scope includes occupational monitoring in medical radiation practices through the accompanying application form; it is not a medical-device product approval or dosimetry-provider licence. The template prints no formal instrument number, legal issue date, monetary fee or processing deadline and does not cite the 2025 provider-licensing guide. The upload path is not an adoption date. Present applicability and later revisions remain unverified.

ANEA laboratory application form for its individual occupational radiation-monitoring service. Its practice table explicitly includes radiotherapy, nuclear medicine and diagnostic radiology, alongside industrial and other practices. It requests institution, radiation-protection officer, exposed-worker and radiation-source details, dosimeter use and storage arrangements, emergency contacts and a legal representative declaration. The four-page form lists supporting documents and contractual service conditions, including 30-day dosimeter use, return and exchange. It mentions a service fee without an amount. These are service enrolment conditions, not medical-device product authorisation, provider-licensing rules or a national processing deadline. No formal form number or legal issue date is printed; upload-path dates do not establish adoption. Present applicability and later revisions remain unverified.

ANEA request-letter template for adding occupationally exposed workers to an existing external individual dosimetry service contract. It retains the company, address, NUIT, contract-number, date and signatory placeholders and lists the service application form and worker identification and curriculum vitae attachments. Its medical relevance follows the accompanying application form that includes medical radiation practices. This is worker administration for a monitoring service, not a medical-device product variation or provider-licensing application. No formal instrument number, legal issue date, monetary fee or national processing deadline is printed, and the template does not cite the 2025 provider-licensing guide. Upload-path dates do not establish adoption. Present applicability and later revisions remain unverified.