Clinical investigation & performance by country

Confirmation of conformity under normal conditions of use and assessment of undesirable side effects must be supported by clinical data, particularly for implantable and class III devices; clinical data may be based on existing scientific literature (demonstrating equivalence of the device), a critical evaluation of all clinical investigations carried out, or a combined critical assessment of both.

Clinical investigations require authorization by the minister responsible for health, granted to the manufacturer or its representative that has registered activity in Albania, based on complete documentation and approval of the ethics committee; the minister grants or refuses within 60 days of receipt of the request and documentation; silence within the 60 day period counts as authorization granted; the ethics committee may propose to the minister revocation, suspension/termination of the investigation, or modification of any of its aspects.

For devices requiring clinical studies, clinical data must appear in the homologation dossier, unless use of existing clinical data can be justified through available scientific documentation where the applicant demonstrates proven equivalence of the device with the device to which those data relate.

ANMAT is the body responsible for authorizing and controlling experimental clinical investigations in medicines, food and medical products, and for issuing the governing regulation; approval verifies scientific and ethical standards, licensed (matriculated) professionals and habilitated sites, with ANMAT inspection powers.

Devices intended for research or clinical trials are exempt from registration, provided the legal provisions of the competent health authority for such activities are met; commercialization and any other use are prohibited.

The authorisation to carry out a clinical investigation of a medical device and of an interventional clinical laboratory study assessing the effectiveness of an in vitro diagnostic medical device is granted by the authorised body (Ministry of Health), which approves the investigation programme and the attached documents on the basis of a positive expert conclusion of the Expert Organisation and a positive conclusion of the clinical investigation ethics committee. For clinical investigations of in vitro diagnostic medical devices (other than interventional studies assessing their effectiveness) and of software medical devices, the authorised body is notified at least 10 days in advance in the procedure established by legislation. The ethics committee is a body operating on a voluntary basis whose membership selection procedure, individual composition and working rules are established by the authorised body; its members are independent and subject only to the Constitution and the laws. Experts examining clinical investigation materials and ethics committee members must sign a declaration on conflict of interest and confidentiality for each investigation, and refusal to sign ends their powers and bars them from that examination. Only medical organisations included in the list kept by the authorised body may conduct clinical and clinical laboratory investigations of medical devices.

Clinical evidence is required to substantiate a kind of medical device's compliance with the Essential Principles (Schedule 1 and Part 8 of Schedule 3 of the MD Regulations); clinical evaluation procedures must be applied to the device under reg 3.11(1), and TGA's Clinical evidence guidelines for medical devices set out how to compile and present the evidence.

Applications, notifications, reports and other documents in clinical investigation and performance study procedures must be submitted to BASG mandatorily and exclusively in electronic form on the basis of § 2 Abs. 3 of the Elektronische Einreichverordnung (EEVO) 2011.

An application to BASG for a clinical investigation or performance study (initial application or amendment) must contain the final positive ethics committee vote; a provisional vote or a processing notice does not count as a final vote; documents must match the versions approved by the ethics committee; submission to BASG while the ethics procedure is still running is expressly not recommended and typically leads to rejection of the application.

Under article 6.5.4 of the Law on Medicinal Products, products intended for the conduct of scientific research, preclinical research and clinical trials are among the products that are not subject to state registration, and the use of those products is permitted only where there is a decision of the relevant executive authority. Medical devices are equated to medicinal products for the purposes of article 6.5.4: the device equivalence clause in article 1 1 excludes articles 6.5.2 and 6.5.8 from the deeming but not article 6.5.4. The rules for conducting scientific research, preclinical research and clinical trials of medicinal products are established by the relevant executive authority (article 6.9); those rules are the Rules approved by Cabinet Decision No. 83 of 30 April 2010, under which a clinical trial is carried out on the basis of an authorisation of the Ministry of Health (article 1.5) and in medical prophylactic institutions designated by the Ministry and accredited (article 4.1); all clinical trials must be conducted in accordance with the ethical principles of the Helsinki Declaration (1964) and the Ministry's rules on protection of trial subjects, and only where the expected benefit outweighs the risk (article 4.2); trials on a human being may be conducted only with that person's written informed consent and under a contract between the person and the sponsor, and after positive results have been obtained in scientific and preclinical research on animals (article 4.3); supervision of compliance with legal and ethical norms during preclinical research is exercised by the Ministry of Health or a body it authorises (article 1.2). Trials are prohibited on minors (article 4.5.1), pregnant women (article 4.5.2), persons in military service (article 4.5.3), convicted and detained persons (article 4.5.4) and persons declared incapacitated by a court (article 4.5.5), subject in the cases of minors, pregnant women and psychiatric patients to an exception where the medical technology under trial is specifically designated for the treatment of that population.

The 2024 checklist requires for Phase II–III: cover letter, application form, signed dated protocol, Investigator's Brochure, sample ICF and CRF, clinical trial insurance policy with corporate indemnity and malpractice clauses, CVs of investigators, sponsors, CROs and monitors, investigators' licences, IMPD or CMC, sample investigational product labelling and packaging, GMP certificate of the manufacturing facility, letter of authorisation to manufacture, certificate of analysis and quality, authorisation for a Bahrain registered CRO, IREC approval letter and the clinical trial agreement. Phase IV applications omit the IB, insurance, IMPD/CMC, labelling, GMP, manufacturing authorisation and analysis certificates, but a Summary of Product Characteristics or Instructions for Use is required to show the product is used per its registration conditions.

All research involving human beings must be reviewed by an Institutional Independent Research Ethics Committee (IREC) or, for private hospitals, the NHRA Ethics Committee for Private Hospitals, and sponsors must obtain such approval from each institution where the trial will run; local IRB/IREC approval letters are required before commencing any clinical trial or research activity in the Kingdom. For Phase II and III trials, the sponsor submits a cover letter and signed application form to the office of the NHRA Chief Executive Officer with two hard copies and one electronic copy of the package, organised in four parts (administrative; protocol and related documents; investigational product manufacturing and labelling; agreements, financial disclosures, investigator statement and proforma invoices).

NHRA states that it will withdraw or suspend a clinical trial authorisation, as a whole or in part, if the sponsor and/or applicant fail to comply with any relevant NHRA regulatory requirement.

The NHRA guide defines a clinical trial as any investigation or experiment in human subjects of an investigational product, expressly including medical devices, and defines an investigational product to include a medical device, a product already holding a marketing authorisation but used differently from the authorised form, or one used for unapproved indications.

Within 10 business days of receipt NHRA, on the recommendation of its Clinical Trial Committee, either accepts the application and starts review, issues a letter of deficiency and puts the application on hold until the deficiencies are completed, or refuses it for incompleteness, an unqualified applicant or invalid documents. The applicant must address deficiencies within 30 days before review begins. NHRA then issues a no objection or authorisation letter.

No amendment to an approved protocol may be implemented without IREC/NHRA ECPH approval. NHRA treats any change that is not non substantial as substantial, so the sponsor must await NHRA re authorisation before implementing it, submitting a cover letter, summary of the amendment, list of modified documents with versions and dates, tracked changes, signatures and the IREC approval letter. Minor amendments may be implemented once the IREC confirms they are non substantial, and that confirmation is submitted to NHRA with the yearly progress report.

Pre clinical, clinical, field or performance trials and biocompatibility or bioequivalence studies on drugs, vaccines and medical devices are conducted by Contract Research Organizations; they require the Licensing Authority's approval plus separate protocol approval, without which no such study may be conducted on any medical product used in the treatment of humans or animals.

Clinical trials of medical products are conducted only in state healthcare organizations, after laboratory and other tests confirming safety; participation is voluntary with written informed consent; trials on pregnant women and minors are allowed only where the device is intended exclusively for them; trials are prohibited on orphans, military personnel, detainees/convicts, legally incapacitated persons and persons under forensic examination.

Minimum/maximum clinical trial durations: class 1 — at least 10 and at most 30 calendar days; class 2a — 35 to 70 calendar days; classes 2b and 3 — a period sufficient to establish the corrective effect (implantable devices: at least 70 calendar days). Classification follows the EAEU rules approved by EEC Board Decision № 173 of 22.12.2015.

FAMHP is responsible for validation of clinical investigation authorisation applications evaluated at national level and under the coordinated procedure; it consolidates its own assessment and the ethics committee opinion into a single report (with national and coordinated parts under MDR Article 78).

Application dossiers and post market clinical follow up (PMCF) notifications may be submitted in one of the three national languages or in English; documents addressed to participants must be provided in the language(s) of the participants.

Belgium has implemented a synchronized procedure to support sponsors in the submission of combined studies that fall under both the Medicines for Human Use Regulation (CTR) and the MDR/IVDR; FAMHP guidance (version 1.0) gives sponsor specific guidance for this synchronized procedure.

statement: For products classified as moderate high risk and high risk, particularly for new products, clinical studies on use must be presented to demonstrate the safety and efficacy of the product (numeral 2.4.8). The manual sets out no device specific clinical investigation authorisation procedure, but its legal table (numeral 1.3.6, row 28) lists the 'Norma para Estudios Clínicos' approved by Resolución Ministerial N° 0834 of 23 November 2004 among the norms of the registration framework; that norm was not read and its device reach is not asserted here. · article: Numeral 2.4.8

Before clinical investigation of a medical device begins on the territory of BiH, the intended investigation must be registered with the Agency. The applicant may be the sponsor of the investigation or, on its behalf, the principal investigator. If the applicant does not receive a negative response from the Agency within 30 days of receipt of the registration, it is considered that the clinical investigation may begin. The Agency must, no later than 30 days after receipt of a complete registration, inform the applicant of the reasons for rejection by a decision that is final in the administrative procedure, against which no appeal is permitted but an administrative dispute may be brought before the competent court. The period stops running on the day the Agency requests additional data or explanations and resumes when the request is met.

Clinical evaluation is part of the conformity assessment procedure for a medical device and is governed by BoMRA's dedicated guidance (BOMRA/ER/MED/P04/G02), which sets out the general principle, the sources of clinical data, appraisal and analysis of clinical data, and the clinical evaluation report. The summary technical documentation for a Class B, C or D device must include pre clinical studies where applicable and the clinical evaluation report summarised per the current IMDRF guidance documents.

The Dossiê de Investigação Clínica de Dispositivo Médico (DICD) must be submitted to ANVISA before conducting a clinical investigation involving a class III or IV device.

Section 23(1) of the Medicines Act prohibits conducting any clinical trial in Brunei Darussalam without prior written approval from the Brunei Darussalam Medicines Control Authority. The Act's s. 2(1) defines a 'clinical trial' as investigations on persons to determine 'the safety, effectiveness and other effects of any product', and 'product' is not defined, so the approval requirement is not on its face limited to medicinal products. No rules under s. 23(2) prescribing trial conditions, and no device specific investigation guidance, have been published.

Within 90 days after completion of the clinical investigation, the sponsor must submit to BDA a final report on the investigation.

Clinical investigations of class III, implantable and long term invasive class IIa/IIb devices and active implantable devices may start only after a permit from the Executive Director of ИАЛ (BDA), issued upon receipt of a positive opinion of the Ethics Committee for Clinical Trials; other investigations require notification only.

In the common submission dossier, clinical evidence of effectiveness may comprise medical device related investigations conducted domestically or in other countries, and may be derived from relevant publications in peer reviewed scientific literature, with the submitted evidence documenting objectives, methodology and results in context. Foreign clinical evidence is therefore accepted; the instrument states no requirement for a local investigation as a condition of registration.

For medical devices intended for clinical investigation, the Regulatory Authority of the Member State may require the product owner, its authorised representative or the sponsor of the clinical investigation to follow the Annex 8 clinical investigation procedure and to register with the Regulatory Authority of the Member State in which the investigations are to be conducted. The authority may also require the investigation report to be submitted or made available on request, and must be notified of the end of the investigation with justification where it was suspended or terminated early.

No person may import or sell a medical device for investigational testing involving human subjects unless, for Class II, III and IV devices, the manufacturer or importer holds an authorization under s.83(1) and keeps the records required by s.81; for Class I devices only the s.81 records are required.

For Class II devices and Class III or IV in vitro diagnostic devices that are not for near patient use, the investigational testing application need only contain the reduced information set (the s.81 items in paragraphs (a), (b) and (h) to (j)) rather than the full application content.

Devices (elementos de uso médico) used in scientific research in humans require a special authorization for provisional use granted by ISP — required both for unregistered devices and for registered devices intended to be used differently from their registration. The application (after approval under Article 10 of Law N°20.120) includes the investigation protocol, informed consent form, insurance policy and other regulatory documents; the authorization may not exceed 1 year, renewable for equal successive periods; ISP keeps a public registry of authorized studies.

The authorization holder, sponsoring entity, principal investigator and the study center are responsible for notifying ISP and the corresponding Scientific Ethics Committee of adverse reactions and adverse events occurring during the study, within the time and form set by the respective regulation, and for complying with pharmacovigilance/tecnovigilance rules.

Registration/filing requires clinical evaluation unless a Decree Art. 24 exemption applies; evaluation may be satisfied either by a clinical trial or by analysis of clinical literature and data of equivalent (same variety) devices. Clinical trials must follow medical device GCP at qualified trial institutions, with filing to the provincial drug regulatory department.

Clinical trials of Class III devices presenting high risk to the human body require prior NMPA approval before the trial may proceed; the approval application is decided within 60 days with silence deemed consent.

Prototype medical devices and controlled technology biomedical equipment (national or imported) may be authorized only for research and experimentation purposes and may never be used in healthcare delivery; importing prototypes requires a technical opinion (concepto técnico) from INVIMA under the health research rules in force.

For classes IIb and III, the technical evaluation dossier must include clinical studies (estudios clínicos); for classes IIa, IIb and III it must include scientific information and risk analysis.

Serious adverse events occurring in clinical studies with medical devices must be notified to INVIMA using the official form 'FORMATO PARA NOTIFICACION AL INVIMA DE EVENTOS ADVERSOS SERIOS PRESENTADOS EN ESTUDIOS CLINICOS CON DISPOSITIVOS MEDICOS' (code ASS RSA FM171).

Class 3 and 4 registrations require clinical evidence composed of the manufacturer's clinical evaluation document, preclinical studies where applicable, human clinical studies (or, for well established technology, third party studies on the product or a similar product with a manufacturer equivalence declaration and supporting evidence), software validation study where applicable, bibliographic studies, and a risk analysis/evaluation summary; class 4 additionally requires published post market reports.

For IVDs, comparative investigative performance tests performed on the EMB using human samples representative of intended users under conditions similar to expected use may be submitted as clinical evidence, accompanied by a declaration by the product holder attesting to the truthfulness of results.

For all medical devices, the demonstration of conformity with the essential principles includes a clinical evaluation carried out in accordance with the competent authority's guidelines. The clinical evaluation is to examine clinical data in the form of clinical investigation reports and/or reports or reviews of the literature and clinical experience, in order to establish that a favourable benefit/risk ratio exists for the device. Clinical investigations on human subjects are to be conducted in the spirit of the Declaration of Helsinki, from the identification of the need and justification for the study through to publication of the results, and certain countries may have specific regulatory requirements for protocol review before the study or for informed consent.

In Croatia the approval for conducting a clinical investigation of a medical device or a performance study of an in vitro diagnostic medical device is granted by the Ministry of Health, not by HALMED. A positive opinion of the Central Ethics Committee is an integral part of the approval procedure. The approval is granted or refused by decision against which no appeal lies, but an administrative dispute may be initiated. The Ministry also monitors and supervises the conduct of clinical investigations and performance studies and takes corrective measures.

Resolución CECMED No. 138/2015 (approved 31/08/2015, in force 31/10/2015) approved Regulación E 79 15 Edición 3, 'Presentación de evidencias clínicas para el Registro Sanitario de equipos y dispositivos médicos', which governs the clinical evidence presented with registration applications; it derogated Regulación ER 6 (requirements for clinical trials of medical equipment) and Guía GT 4a (protocols and final reports). CECMED grants the authorizations for executing clinical investigations involving devices (E 132 25, epígrafe 3.44).

A clinical investigation of a medical device or a performance study of an in vitro diagnostic medical device conducted in Cyprus requires a licence from CYMDA, provided that the Cyprus National Bioethics Committee has not issued a negative opinion. Clinical investigations are designed, authorised, conducted, recorded and reported under Article 62 and Articles 63 to 80 of Regulation (EU) 2017/745 and the acts adopted under its Article 81, and under Annex XV; performance studies are conducted under Articles 56 to 57 and 59 to 77 of Regulation (EU) 2017/746, the acts adopted under its Article 107, and Annexes XII and XIV.

For clinical trials of medical devices in Cyprus, the provisions of Articles 61 to 80 of Regulation (EU) 2017/745 apply.

Until the EUDAMED clinical trials module is fully functional, applications for clinical investigation authorisation under MDR Art. 62 and Art. 74(1) (2) are submitted through the Register of Medical Devices (RZPRO) established by former Act 268/2014 Sb.; IVDR performance study applications under Art. 66/70 likewise use RZPRO (§ 74(4)).

The sponsor of an MDR Art. 82 other clinical trial must file with SÚKL via ISZP, 60 days before starting, a notification of intent including Annex XV chapter II documentation (points 1, 2, 3, 4.2, 4.4) and the ethics committee opinion; the trial may start after 60 days from the notification, at the latest within 1 year, unless SÚKL decides otherwise.

A healthcare provider notifies SÚKL via ISZP of the establishment, dissolution and change in composition of its ethics committee, without undue delay and at the latest within 30 days; dissolution must also be announced to all sponsors whose trials the committee oversees within 5 working days. The notification contains the committee name, contacts, members and their specialisations, chair and dates.

The sponsor is liable for injury suffered by a trial subject due to participation in a clinical investigation or performance study conducted in the Czech Republic, and must arrange, before the start and for the whole duration and full extent of this liability, insurance covering injury caused in connection with the investigation/study; scope and limit must correspond to the risks.

Clinical investigations under MDR Article 62(1) may only start after authorisation from the Danish Medicines Agency; the application under MDR Article 70 is submitted by the sponsor or the sponsor's representative to DKMA. The sponsor must immediately report serious adverse events and device deficiencies under MDR Article 80(2) (3) to DKMA, notify DKMA of the end of the investigation (Art 77(3)), and send the clinical investigation report and summary (Art 77(5)) to DKMA; suspensions/terminations must be communicated per Art 77(1).

Applications for performance studies within IVDR Article 66(1) are submitted by the sponsor or the sponsor's representative to the Danish Medicines Agency; DKMA cannot authorise if there is a negative opinion from a scientific ethics committee. The sponsor must immediately report serious adverse events and device deficiencies (IVDR Art 76(2) (3)) to DKMA, notify the end of the study (Art 73(3)), submit the report and summary (Art 73(5)), and inform DKMA of suspension/termination (Art 73(1)).

statement: Every clinical and biomedical investigation carried out in Dominican territory must obtain CONABIOS's prior approval and be supervised by it, the protocol having to respect the life, integrity and dignity of participants, obtain informed consent under the bioethics rules in force, guarantee participant confidentiality, present no unjustified risk with benefits proportional to the risks, and contain all requirements of CONABIOS's Manual de Normas y Procedimientos Operativos. CONABIOS monitors each approved investigation continuously and may revoke the authorisation or suspend the investigation provisionally according to the gravity of the breach; responsible investigators must send it the reports and documents it requires at the periods it sets. · article: ARTICULO 10 y Párrafos I III

Registration of class III and IV devices requires clinical studies or, for SaMD, clinical evaluation specific to the device technology (for DMI, DMA and DMDIV); biofunctionality studies based on scientific evidence and functional performance tests are required for implantable devices of classes III IV; IVDs of all risk classes require performance studies (precision/repeatability/reproducibility, sensitivity, specificity, and other applicable performance or clinical studies per internationally recognized guidelines).

Devices for human investigations used by specialist practitioners in an adequate clinical research setting, without commercialization purpose, do not require sanitary registration; the Ley Orgánica de Salud separately allows importation of unregistered devices for human clinical research purposes.

Interventional research in Egypt using new medical devices not previously used in humans and not accredited by international bodies falls under EDA clinical trial oversight (Law 214/2020). For locally manufactured devices the applicant must first obtain technical file approval and classification from the Central Administration of Medical Devices before protocol submission; imported devices (with or without international quality certification) proceed directly to protocol submission and evaluation.

Where a study is planned to be conducted only in Estonia, or only in Estonia and in a country that is not a European Union or European Economic Area member state, and the sponsor is not registered in a European Union member state, Ravimiamet may, on the sponsor's application, authorise the sponsor to designate a contact person for the study in its place, proceeding from Article 62(2) of Regulation (EU) 2017/745 or Article 58(4) of Regulation (EU) 2017/746 respectively. Ravimiamet grants that authorisation where it carries no significant risks to the safety or rights of study participants and the requirements laid down in Regulation (EU) 2017/745 or Regulation (EU) 2017/746 and in the Medical Devices Act are met. A sponsor wishing to designate a contact person in its place may submit the study application documents to Ravimiamet after it has received the authorisation to use a contact person.

A sponsor must notify Ravimiamet at least ten days before starting a study where the sponsor plans to conduct a clinical investigation referred to in Article 74 of Regulation (EU) 2017/745 that entails procedures for participants that, beyond the procedures carried out under the device's normal conditions of use, are neither invasive nor burdensome, or a performance study referred to in Article 58(2) of Regulation (EU) 2017/746 that investigates a companion diagnostic using only residual samples.

EFDA states that a proper clinical evaluation demonstrates which clinical data are necessary and can be adequately contributed to by sources such as literature searching, prior clinical investigations including clinical data generated in other jurisdictions, clinical experience, or clinical data available from comparable devices; clinical data should be generated from clinical investigations only when data are unavailable or insufficient to demonstrate conformity to the Essential Principles. For long established technologies the clinical investigation data that might be required for novel technologies may not be necessary, and available clinical data such as published literature, reports of clinical experience, post market reports and adverse event data may in principle be adequate, provided that new risks have not been identified and the intended use has not changed.

For in vitro diagnostic medical devices, all claims for the clinical performance of the product must be supported by well designed performance evaluations. EFDA accepts evaluations that have been carried out or coordinated by the manufacturer as well as evaluations carried out by bodies wholly independent of the manufacturer, and requires for each performance study submitted in the dossier a study description with record traceability, a study summary with a conclusion, and the full study protocol and report, including the site(s) where the study was performed and the geographical region of the subjects. Estimates of diagnostic or clinical sensitivity and specificity must be reported with 95% confidence intervals.

The clinical investigation authorization guideline applies to the conduct of clinical investigation on human beings in Ethiopia to assess the safety and/or performance of medical devices for regulatory purposes, and it applies to investigational devices that fulfil the medical device definition in Proclamation No. 1112/2019. The guideline states expressly that it does not apply to in vitro diagnostic medical devices, so IVD clinical performance evidence follows the IVD registration guideline instead.

Confirmation of conformity with the general safety and performance requirements must be based on clinical data providing sufficient clinical evidence, including evaluation of undesirable side effects and benefit risk acceptability; the manufacturer must specify and justify the level of clinical evidence necessary (Art. 61(1) MDR). Clinical evaluation per Annex XIV including post market clinical follow up (PMCF) is a general manufacturer obligation (Art. 10(3)).

For implantable devices and class III devices, clinical investigations must be performed, except in defined cases (e.g. modifications of a device already marketed by the same manufacturer where equivalence is demonstrated and endorsed by the notified body, and the exemptions of Art. 61(10) such as use of CS or demonstrated equivalence relying only on non clinical testing); justifications are subject to NB scrutiny (Art. 61(4), (10) MDR).

IVD conformity with the GSPR (in particular performance characteristics) must be based on scientific validity, analytical and clinical performance data providing sufficient clinical evidence, including evaluation of interferences/cross reactions and benefit risk acceptability; the manufacturer specifies and justifies the required level of clinical evidence (Art. 56(1) IVDR); performance studies are regulated in Arts. 58 77 IVDR.

Application documents under MDR Annex XV chapter II / IVDR Annex XIV chapter I may be in Finnish, Swedish or English; however, the documents under MDR Annex XV ch. II points 1.11, 3.13 and 4.4 and the corresponding IVDR points (e.g. informed consent materials) must be submitted in Finnish or Swedish.

The sponsor must ensure that insurance or other appropriate security is in force to compensate damage caused to study subjects, covering the liability of both the sponsor and the investigator.

For combined medicinal product/diagnostics performance studies under IVDR Art. 58(2) that use only samples not obtained from study subjects, or samples obtained under the Biobank Act (688/2012), the sponsor must notify Fimea at the latest 10 days before starting the study.

Where a clinical investigation or performance study is to be conducted exclusively in Finland (or in Finland plus a non EU/EEA country) and the sponsor is not established in the EU, the sponsor must appoint the legal representative referred to in MDR Art. 62(2)/IVDR Art. 58(4); Fimea may, on application, permit a contact person instead, and the application may be submitted only once that permit is legally final.

Until the EUDAMED clinical investigation module is taken into use, applications and notifications are submitted to Fimea electronically via Fimea's secure mail service (secmail.fimea.fi, max 50 MB including attachments) using the application form based on MDCG 2021 8 annex 1, or by post; by law, if the EU electronic system is not functional, the application or notification is submitted to Fimea (59 § 5 mom).

Clinical investigations to demonstrate conformity of a device (or otherwise requiring authorisation, e.g. categories 2c/d and 4 of R1125 1) may start only after both a favourable CPP opinion and the ANSM authorisation under Art. L1125 1 II CSP; investigations undergo scientific and ethical review per MDR Art. 62(3); the dedicated chapter L1125 1 to L1125 32 CSP was created by Art. 2 of Ordonnance n° 2022 582.

Clinical investigations of medical devices are conducted under the technical regulation approved by Government Decree No. 386 of 3 October 2023 and must be registered with the Agency. For class IIa, IIb and III devices the Agency registers the investigation only on the basis of a positive recommendation of the Coordination Council for Clinical Investigations of Medical Devices; for all other classes the registration certificate is issued by Agency decision. A clinical investigation is conducted for all medical devices and active implantable medical devices, and for class III devices based on technology not previously used or used only rarely, or where the scope of use of the device is being extended. Where available clinical data from the clinical evaluation are insufficient to confirm efficacy and safety, the manufacturer must also carry out a clinical investigation.

For clinical investigations, performance studies and other clinical investigations, insurance must be taken out with an insurer established in an EU/EEA state in favour of the persons affected, covering death or injury to body or health (also where no one else is liable); minimum cover is EUR 500,000 per case of death or permanent incapacity to work.

The clinical investigation authorisation required under MDR Art. 62(4)(a) must be applied for by the sponsor at the competent federal higher authority, BfArM; the application is submitted by electronic data transmission via the central DMIDS system in accordance with MDR Art. 70(1), with the documents listed in MDR Annex XV Chapter II attached.

The authorisation for a performance study required under IVDR Art. 58(1) or (2) must be applied for by the sponsor at the competent federal higher authority; the application is submitted by electronic data transmission via DMIDS in accordance with IVDR Art. 66(1), with documents per IVDR Annex XIII sections 2 and 3 and Annex XIV attached.

Serious adverse events (SAE) and device deficiencies (DD) occurring in approval or notification requiring clinical investigations must be reported to BfArM in accordance with MDR and MPDG (correspondingly for IVDR performance studies).

For clinical investigations and performance studies conducted only in Germany or in Germany plus third countries, there must be a sponsor or a legal representative of the sponsor (within the meaning of MDR Art. 62(2) subpara 1) with its seat in an EU member state or another EEA contracting state.

For clinical trials already approved by a well resourced NRA, FDA may activate a reliance pathway case by case or at the applicant's explicit request; the applicant submits the full CTA plus the full assessment reports, identical to what was submitted to and approved by the reference NRA.

A decision to defer, approve or reject a clinical trial application must be taken within 60 working days for a routine application, 30 working days for an abridged evaluation after the reliance pathway is activated, and 21 working days for trials during emergency situations.

A person shall not conduct a clinical trial of a medical device (or drug, herbal medicinal product, cosmetic or procedure) without an approved valid certificate issued by the FDA; FDA is the final body authorising trials following Ethics Committee approval.

Clinical investigations under Article 62 MDR are submitted to EOF for evaluation and approval. The dossier = cover letter (with contents list and Greek budget summary) + General Part per Annex XV Chapter II MDR (MDCG 2021 8 application form in English, searchable pdf) + Special Part with 13 numbered elements, including the Greek language application form, clinical investigation plan synopsis in Greek, patient information/consent forms in Greek (plus English originals), investigator sponsor agreement, investigator CV with ICH GCP training evidence, CE marking and declaration of fidelity (if any), National Ethics Committee (Εθνική Επιτροπή Δεοντολογίας) opinion if already issued, Greek label specimen bearing 'αποκλειστικά για κλινική έρευνα', sponsor's responsible statement on pharmaceutical substances/tissues, fee proof (EUR 1,000), insurance contract in Greek, and Greek study budget.

Clinical investigations under Article 74(1) MDR require notification to EOF at least 30 days before the start of the clinical investigation in Greece (dossier: cover letter with justification of Art. 74(1) classification + General Part per Annex XV Ch. II, MDCG form in English). No fee is charged for the initial notification or notification of modifications of Art. 74(1) studies; substantial modifications must be notified at least 30 days before implementation in Greece.

Clinical investigations under Article 82 MDR (devices for performance evaluation etc. not meeting Art. 82(1)(a) conditions context) are not submitted to EOF for approval; per the guidance, the provisions of Art. 62(2) first sentence, 62(3), 62(4)(b),(c),(d),(f),(h),(l) and 62(6) apply.

IVD performance studies under Regulation (EU) 2017/746 are handled by EOF with dedicated national guidance ('Εφαρμογή του Κανονισμού (ΕΕ) 2017/746 στις μελέτες κλινικών επιδόσεων In Vitro Διαγνωστικών', V.1.2, 28.11.2024) and Greek forms (DFME E4800 1 initial / E4800 2 amendment, Special Part); with the application of IVDR, EOF Circular 42353/09.06.2011 on IVD studies is fully repealed.

A clinical investigation of a medical device in Guatemala requires the research protocol to be authorised by the DRCPFA under Acuerdo Ministerial 206 2021. For a device trial the sponsor, investigator, CRO or SMO must file a device specific dossier: general information (generic name, trade name, components and their detailed description, dimensional plan or design, additional substances, applicable national and foreign standards, international marketing evidence, sterility conditions, manufacturing/processing/packaging methods and controls, expiry or useful life, and any further information the nature of the equipment requires); information on the materials (manufacturer of each component, physical and chemical tests on raw materials, applicable standards, and functioning information including the mechanism of action, energy delivery to the patient, organs and tissues involved, area and mode of application, and interaction with other devices in contact with the patient); a copy of the device's Good Manufacturing Practice certificate issued in the country of origin with the corresponding legal formalities and a sworn translation where applicable; preclinical information; in vitro tests showing the absence of carcinogenic, teratogenic or other degenerative or adverse effects, with material characterisation, degradation products and exposure conditions; in vivo tests in experimental models; the consent letter signed by the directors of the health establishments; and a copy of the trial's insurance policy. The Department verifies within five calendar days that the application meets the requirements and notifies the applicant of its acceptance.

Clinical evaluation following defined processes (identify Essential Principles needing clinical data, identify/appraise/generate clinical data, draw conclusions) must be documented in a clinical evaluation report; the clinical evaluation plan may be requested to substantiate the methodology.

There is currently no specific Hong Kong legislation regulating clinical trials of medical devices; local clinical study data is not a standing requirement for MDACS listing.

A supporting opinion of the ETT TUKEB (ethics committee) must be attached to the clinical investigation application; it is a condition for issuing the investigation authorization.

IVDs intended for performance evaluation are subject to notification to the authority but may not be placed on the market.

Clinical investigations of medical devices in Hungary may be conducted only on the basis of an NNGYK authorizing decision, under the conditions specified in that decision and the approved investigation plan, per 33/2009. (X. 20.) EüM rendelet 1. § (3) and 16. § (1).

A clinical investigation of a medical device may only be carried out with the permit of Lyfjastofnun and of vísindasiðanefnd (the national bioethics committee). The application is sent to Lyfjastofnun under Chapter VI of the Regulations; the agency and the ethics committee assess it together, and they supervise compliance. Detailed rules on informed consent, recording of adverse events and the coordinated assessment procedure in clinical investigations follow Chapter VI of the Regulations, and the fee for assessing a clinical investigation application for all classes is ISK 1,161,450.

Import or manufacture of a device without a predicate requires prior permission after clinical investigation (application Form MD 26, permission Form MD 27, decision within 120 days extendable by 30, fee INR 50,000). The CLA may abbreviate, defer or omit data for life threatening or special relevance indications; Class A investigational devices may not need investigation data; and clinical investigation results may be omitted where the device is approved in the UK, USA, Australia, Canada or Japan, has been marketed there at least two years, no Indian population difference is expected, and the applicant undertakes post marketing clinical investigation.

No sponsor may conduct a clinical investigation of an investigational device in human participants except under CLA permission (application Form MD 22 with Seventh Schedule data; permission Form MD 23; decision within 90 days per rule 52(ii)); academic clinical studies on licensed devices need no permission where the Ethics Committee approves and the data will not be used for a marketing application.

Clinical evidence is required for class C and D devices and for new devices impacting human safety and health; it may take the form of a systematic literature study, clinical evidence on similar devices, or a clinical investigation. A clinical investigation is required where the manufacturer has no clinical evidence. Preclinical results (biocompatibility/biological evaluation) are required only for class C and D devices.

Clinical investigations of health supplies must comply with Cara Uji Klinik yang Baik (CUKB, device GCP) and obtain a clinical trial approval letter (surat persetujuan pelaksanaan uji klinik); trial organisers must register the trial. The CUKB for devices is set by the Minister.

Diagnostic laboratory (IVD) kits undergo the directorate's evaluation protocols — both qualitative (پروتکل ارزیابی کیفی کیت‌های تشخیص آزمایشگاهی) and quantitative (پروتکل ارزیابی کمی) — as part of the licensing dossier.

A sponsor must not start a clinical investigation of the Article 62 type in Ireland until HPRA has notified the sponsor of its authorisation within the period referred to in MDR Article 70(7)(b).

All clinical investigations in Ireland must receive ethics approval from the National Research Ethics Committee for Medical Devices (NREC MD) before starting; the NREC MD review is independent of the HPRA review and a copy of the opinion goes to HPRA (S.I. 261 of 2021 reg. 11).

For clinical investigations outside Articles 62 and 74 (Article 82 type), the sponsor must notify HPRA in writing at least 30 days before commencement; HPRA confirms the investigation may start at least 30 calendar days after notification, provided NREC MD ethical approval is also in place.

IVDR Article 58(1) performance studies (surgically invasive sample taking only for the study, interventional clinical performance studies, additional invasive procedures or risks, or companion diagnostics) require HPRA application and authorisation for all IVD classes A D; Article 58(2) companion diagnostic leftover sample studies and Article 70(1) in intended purpose studies with additional invasive/burdensome procedures require notification (Article 70(1): at least 30 days before commencement); Article 70(2) studies require the full Article 58 77 application.

During medical device clinical investigations, SAEs and device deficiencies are reported to HPRA at devices@hpra.ie using MDCG 2020 10 forms; for IVD performance studies, reports go to devicesafety@hpra.ie until EUDAMED PS modules are functional. Safety ground halts/terminations must be notified within 24 hours, other endings within 15 days; the end of study report is due within one year (three months if halted or terminated early).

A one time import approval for clinical evaluation samples is available only if a registration application for the product has already been filed in the register; the import application must state explicitly that the purpose is clinical evaluation. Without a filed registration application, no further one time approval is given.

The national clinical investigation application (for non CE devices and CE devices under MDR Art. 74(2)) must include the favourable opinion of the competent ethics committee; the national rules on ethics committee composition and functioning apply, including the single national opinion regime, without prejudice to MDR Arts. 62 80 and 82 (Art. 16(4)).

No clinical investigation may be started without sending a suitable communication to the Ministry of Health and without the conditions for starting the investigation being fulfilled; national administrative modalities for applications (non CE devices and CE devices under MDR Art. 74(2)) are set by Ministerial decree (Art. 16(2)), and sponsor communications under MDR Art. 74(1), 75, 77 are likewise regulated nationally (Art. 16(3)).

Device approval requires clinical trial results or MHLW accepted substitute evidence, explicitly including documentation created by analyzing information on individuals' physical/mental conditions obtained from medical care (real world data); clinical trials must satisfy device GCP Ordinance No. 36/2005.

Clinical investigations of devices are conducted per Good Clinical Practice rules of RK and/or the EAEU; the state body issues the permission to conduct an interventional clinical investigation of a medical device.

Clinical evaluations are required for all medical devices; if a pre market clinical investigation has been conducted the documentation should be provided, and supporting evidence must be provided for any claims made in labelling or marketing literature.

For devices registered via the Immediate Class B Registration (IBR) route whose labelled use goes beyond the inherent performance of the device, additional clinical data may be requested post registration to substantiate the proposed labelled use.

statement: The State Agency of Medicines issues authorisations for the performance of clinical investigations of medical devices; this is one of the device tasks assigned to the agency by its statute, alongside issuing authorisations for placing specially supplied medical devices on the market and carrying out medical device vigilance. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

Among the label indications the registration dossier must show, the procedure requires, for a device intended for clinical investigations, the mention 'exclusively for clinical investigations'.

A clinical investigation per MDR Art. 2(45) may only start once the ethics commission designated by the Government has delivered a favourable opinion and the Amt für Gesundheit has authorised it; the same applies to MDR Art. 70(7)(a) cases. For MDR Art. 74(1) investigations, the ethics opinion plus information to the Amt für Gesundheit at least 30 days before start is required.

The Government designates the ethics commission responsible for clinical trials (Art. 57(4) Swiss HMG) and is empowered to transfer this function to a Swiss cantonal ethics commission by administrative agreement.

Compensation for damage to participants in IVD performance studies (IVDR Art. 2(42)) must be secured by insurance or guarantee with minimum coverage of CHF 250,000 per person, CHF 20,000 for property damage and CHF 3 million per study; for interventional studies under IVDR Art. 58(1)(b)/(2) and Art. 70(2), or studies with products whose placing on the market, putting into service or use is prohibited in Liechtenstein, the minimums are CHF 1 million / 50,000 / 10 million. Coverage must include damage up to ten years after study completion.

Compensation for damage to trial participants must be secured by insurance or guarantee with minimum coverage of CHF 1 million per person, CHF 50,000 for property damage and CHF 10 million per clinical investigation; for MDR Art. 74(1) investigations the minimums are CHF 250,000 / 20,000 / 3 million. Coverage must include damage occurring up to ten years after completion of the investigation.

For clinical trials under customs treaty law (KlinV/KlinV Mep, Art. 54 HMG): submissions (authorisation applications and notifications) go to the Amt für Gesundheit; Swissmedic reviews on request of the Amt für Gesundheit, which grants the authorisation; Swissmedic forms apply. Per government decision, the Zurich ethics commission is the responsible ethics commission in Liechtenstein. Swissmedic conducts pre and post market trial inspections in Liechtenstein on behalf of the Amt für Gesundheit.

VASPVT issues permits to conduct clinical investigations with a medical device and permits for substantial modifications of a clinical investigation with a medical device.

temporaryInterruptionForSafety: notify within 24 hours; report within 3 months · earlyTerminationForOtherReason: notify within 15 days; report within 3 months · endOfInvestigation: notify within 15 days; summary and report within 1 year (Commission Guideline 2023/C 163/06 template)

In Luxembourg, every clinical investigation application and every substantial modification of a clinical investigation is additionally subject to prior authorisation by the Minister, based on the scientific and ethical opinions of the Direction de la santé and the Comité national d'éthique de recherche (CNER), pursuant to Art. 27 of the Loi du 8 mars 2018 relative aux établissements hospitaliers et à la planification hospitalière.

Until the EUDAMED Clinical Investigation module is operational, the applicant submits the clinical investigation application using the application form in Annex I of MDCG 2021 08, by email to recherchebiomedicale@ms.etat.lu and meddevices@ms.etat.lu (Ministry of Health and Social Security). The application dossier may be written in German, French, Luxembourgish or English; proof of insurance covering the project, the number of participants and the whole study duration is mandatory; participant facing documents (informed consent, questionnaires, recruitment material) must be provided in French and German.

For a substantial modification of a clinical investigation, within one week the applicant informs the ministry of the reasons and nature of the modification and submits the request using the form in Annex I of MDCG 2021 28 to recherchebiomedicale@ms.etat.lu and meddevices@ms.etat.lu, attaching an updated version of the relevant Annex XV Chapter II MDR documentation with the changes clearly visible.

The registration dossier must include clinical evaluation data (and non clinical evaluation data); safety data from expanded access use of trial devices in life threatening conditions without effective treatment can be used to support the registration application.

Conducting a clinical trial of a medical device in Macau requires prior ISAF authorization; before deciding, the ISAF President must obtain a binding opinion of the Life Sciences Ethics Committee.

Unregistered devices imported for clinical research or performance evaluation are exempt from registration under section 5, subject to an exemption application/notification to the Authority: a Device Study (DS) notification (with Clinical Investigational Plan per ISO 14155, Clinical Performance Study Protocol and Investigational Brochure) or a Clinical Research Use (CRU) notification, submitted through the MeDCAst system.

Clinical investigations under the MDR and performance studies under the IVDR are authorised and overseen nationally by the Malta Medicines Authority. The Authority charges EUR 5,000 for an application/notification for a clinical investigation under Articles 62 and 74(1) of Regulation (EU) 2017/745 and EUR 5,000 for a performance study under Regulation (EU) 2017/746; EUR 1,000 for an application/notification under Article 82 of the MDR; EUR 1,000 for a pre submission meeting request; and EUR 500 to modify a clinical investigation or performance study. The Authority also publishes GL MDC01 on reporting adverse events in clinical investigations and performance studies, and runs initial inspections at EUR 1,500 and follow up inspections at EUR 500.

The Secretaría may grant import permits for raw materials or finished products WITHOUT sanitary registration only for: (I) contingency; (II) health policy needs; (III) scientific research, registration purposes or personal use; (IV) laboratory testing.

Human subject research that includes administering a medicine/biological or using a medical device requires prior COFEPRIS authorization of the investigation protocol (trámite COFEPRIS 04 010, Modalidad C 'Nuevos Recursos' covers materials, grafts, transplants, prostheses and physical, chemical or surgical procedures). The dossier includes the registered ethics committee recognition, protocol, investigator and sponsor formats, and investigational product GMP evidence; filed on DIGIPRIS; response time 30 natural days; 2026 fee MXN 8,196.

The evaluation of a dossier for the authorisation of clinical studies with medical devices is charged at 26,054 lei per dossier under AMDM's published tariff list.

Where the manufacturer intends to carry out clinical investigations it may delegate, wholly or partly, to the authorised representative the duties relating to that process, and this must be provided for in the representation agreement. Where the manufacturer plans clinical performance evaluation for in vitro diagnostics, that must also be provided for expressly in the agreement. Where duties are delegated in clinical investigations, the authorised representative must communicate reportable adverse effects.

Clinical evaluation and study results are a mandatory item of the IVD registration dossier. For amendments, clinical evaluation may be required as supporting evidence. No separate clinical investigation authorisation procedure for medical devices was located in the instruments retrieved for this round.

The Agency may carry out a control of a clinical investigation and also at the sponsor's request, and it may accept a control of the clinical investigation carried out, in accordance with good clinical practice guidelines, by an EU member state or another state with the same requirements for conducting clinical investigations as Montenegro.

The Agency issues an approval for a clinical investigation within 40 days of receiving a complete application with documentation, including a positive opinion of the Ethics Committee. If the application is incomplete, the Agency notifies the applicant within ten days of receipt that the application must be supplemented, at the latest within 20 days of receipt of the notification. The 40 day and 10 day clocks do not run until the additional documentation is supplied or the additional explanations requested by the Agency are given. If the applicant does not supplement the application within the 20 day period, the Agency rejects the application as incomplete.

A clinical investigation is carried out in accordance with the guidelines of good clinical practice in clinical investigation, that is, the World Standards Organization standard for clinical investigations of medical devices (ISO 14155). The safety and performance of an in vitro diagnostic medical device are assessed on the basis of clinical performance studies. The good clinical practice guidelines are published on the website of the Ministry and of the Agency.

A sponsor must notify the Agency of the conduct of a post market non interventional clinical investigation. For such an investigation no approval of the Agency is required; the Agency issues a confirmation of receipt of the notification within 15 days of its receipt.

A clinical investigation may be carried out by a sponsor that holds the Agency's approval, and must be carried out in a healthcare institution at the sponsor's expense. A sponsor that has no seat, residence or habitual residence in Montenegro must have a representative in Montenegro who is responsible for the sponsor's affairs in the approval and conduct of the clinical investigation in Montenegro.

The registration certificate may be issued only if the device has first been the subject of either a clinical investigation carried out under the legislation in force, or an evaluation of clinical data through the available scientific literature where the applicant proves a demonstrated equivalence between the device applied for and the device to which those data relate. The investigation or evaluation must allow the device's performance under normal conditions of use to be assessed, the benefit risk ratio to be evaluated and adverse effects determined, and conformity with the essential requirements to be confirmed. The results must appear in the registration dossier.

A clinical evaluation report is required in Class C and Class D import recommendation applications; it is not listed in the Class A or Class B document requirements.

The Central Committee on Research Involving Human Subjects (CCMO) is the (sole) competent authority in the Netherlands for clinical investigations with medical devices and performance studies with IVDs and processes the notifications for these studies; the IGJ supervises compliance with the rules. IVDR performance studies must in many cases be notified to the CCMO (situation changed per 26 May 2022).

A positive WMO opinion issued before 26 May 2021 for a clinical investigation under the old directives is treated as a positive opinion for scientific research with medical devices under the new regime, provided execution of the investigation had already commenced.

Medsafe does not regulate or approve clinical trials for medical devices in New Zealand, but requests that it be informed of them before commencement; trials require ethics committee approval, ISO 14155:2011 good clinical practice is expected, and trial devices are exempt from WAND notification under Schedule 1(h). Serious unexpected adverse events during trials should be reported under Medsafe's voluntary adverse event reporting scheme.

NAFDAC's conformity assessment framework incorporates GHTF SG5 clinical evidence documents: N1R8:2007 Clinical Evidence Key Definitions, N2R8:2007 Clinical Evaluation, N3:2010 Clinical Investigations, and N4:2010 Post Market Clinical Follow Up Studies; class based conformity assessment may require more clinical evidence for higher risk devices.

A clinical investigation of a medical device may be conducted only by a legal entity that meets the prescribed conditions as to premises, equipment and staff and the requirements of good clinical practice, and that is authorised by the Director of the Agency. The investigation must be conducted in accordance with the Declaration of Helsinki, the subject must give written informed consent which may be revoked at any time, and the subjects must be insured for the investigation.

Before a clinical investigation begins the sponsor must notify the Agency, and the notification must contain the data on the medical device under investigation, the results of the safety and performance analysis, the investigation protocol, the ethics committee's opinion, the informed consent form and the information sheet for subjects.

An application to DMP is required for clinical investigations of devices that are not CE marked, or CE marked devices investigated outside the manufacturer's stated intended purpose; this covers both conformity assessment purposes (MDR Article 62(1)) and other purposes (MDR Article 82).

National special requirement: clinical investigations conducted for purposes other than future conformity assessment and CE marking (MDR Article 82) must fulfil all requirements of MDR Article 62; investigations of CE marked devices used within their intended purpose are exempt.

Performance studies of IVDs covered by IVDR Article 58 or 70 require an application or notification to the Norwegian Medical Products Agency (NOMA); performance studies may also require an application to the Norwegian ethics committees (REK KULMU).

The same day the application is emailed to DMP, it must also be submitted to the ethics committee REK KULMU via the REK portal; documents sent to both bodies must be identical, and a negative REK KULMU opinion prevents the investigation from starting.

The general summary of a clinical investigation (MDR Annex XV No. 3.1.5) must be provided in both Norwegian and English (the two versions must be identical per CA guidance).

IVD Class C&D registration requires clinical performance and analytical performance documentation plus stability testing, shelf life testing and software validation.

Class C&D registration requires clinical evidence comprising a clinical evaluation report, stability testing, shelf life testing and software validation where applicable; the evidence is submitted as part of the origin jurisdiction dossier.

Under rule 22(1), an application for an import permit for a small quantity of medical devices, components or raw materials for the purpose of clinical investigation, examination, test or analysis, or a sample for evaluation, is made to the Director, Medical Devices and Medicated Cosmetics on Form 9 with the rule 63 fee; the permit is issued on Form 10 (rule 22(2)).

Pending draft reglamento (NOT in force): for the technical evaluation of Class B, C and D in vitro diagnostic devices the applicant must file the manufacturer's factory insert containing, among the method data, the specific performance characteristics for the qualitative or quantitative method for each sample type and analyte separately, 'including the studies supporting sensitivity, specificity and compatibility with equipment, as applicable'. The IVD performance evidence is therefore the manufacturer's own analytical validation documentation; no performance study conducted in Panama is required by the draft.

Pending draft reglamento (NOT in force): a Class C registration file must contain, on top of all Class B requirements, the manufacturer's clinical evaluation report on the safety and effectiveness of the device ('Informe de evaluación clínica de seguridad y efectividad del fabricante'), plus a description of the manufacturing materials process and of the packaging process. The draft defines a clinical evaluation report as a document issued by the manufacturer describing the process, progress or results of the evaluation and analysis of clinical data on the device, in order to verify clinical safety and performance when used as intended — i.e. the clinical evidence is the manufacturer's own file, not a Panamanian study.

Pending draft reglamento (NOT in force): a Class D registration file must contain, on top of all Class C requirements, a risk management evaluation report based on ISO 14971, the manufacturer's traceability protocol, and 'clinical studies on the satisfactory use of the medical device published in indexed scientific journals or open source type databases'. Foreign clinical evidence is therefore accepted in the form of published literature rather than a Panamanian trial. DNDM may, on stated technical justification, request additional information to evaluate safety and effectiveness.

DINAVISA must authorise or deny requests for amendments to the research protocol and/or informed consent and assent, and additions or changes of investigator and/or research centres, within no more than fifteen (15) business days, or object, in which case the period is suspended by the evaluation report.

Among DINAVISA's responsibilities, Article 18(b) requires it to authorise or deny clinical trial applications within no more than sixty (60) business days, or to object, in which case the period is suspended by the issue of the evaluation report. Under Article 18(a) an application is treated as withdrawn if the sponsor does not answer.

Resolución DINAVISA N° 238/2024 brings within its scope, and subjects to prior authorisation by DINAVISA, clinical trials for medicines, vaccines, medical devices and in vitro diagnostic products conducted with a registration purpose in Paraguay, as well as trials on already registered products studying new indications, routes, concentrations, dosage forms, posologies, combinations or any post registration change requiring registrable clinical data.

The basic accreditation of a research ethics committee (CEIS) is granted by the Ministry of Health and suffices for committees that do not review clinical trials of medicines, vaccines, devices or IVDs; committees that review such trials also need a complementary accreditation granted by DINAVISA and must follow Good Clinical Practice. DINAVISA keeps an updated list of complementary accredited CEIS on its website (Art. 18 g).

In addition to the final reports required by Resolución 238/2024, the sponsor or its legal representative in Paraguay must submit to DINAVISA the global study reports within no more than twelve (12) months from the end of the clinical trial, structured according to the ICH E3 Clinical Study Reports guideline; non compliance is sanctionable.

Resolución DINAVISA N° 056/2026 supplements Resolución 238/2024: the information requested in the Investigator's Manual must comply with the ICH E6(R3) Good Clinical Practice guideline, including its documentary requirements, and failure to comply is a ground for rejection of the clinical trial authorisation application.

Article 34 lists the sponsor's general responsibilities: to request DINAVISA authorisation of the trial before it starts, to request authorisation of substantial amendments before implementing them, and to respond to DINAVISA's objections within no more than thirty (30) business days.

Article 30 of Ley N° 1119/97 requires all clinical trials to be previously authorised by the national health authority under conditions regulated in line with Good Clinical Practice, to respect fundamental rights and the ethical postulates of the Declaration of Helsinki, allows the authority to restrict complex trials to designated hospitals or research centres, and empowers it to order the precautionary interruption of a trial.

Class III and Class IV registration dossiers must include item 9 'Informe de evaluación clínica' (clinical evaluation report), alongside the ISO specific risk management report.

Clinical investigations in humans for conformity with the essential principles must be conducted in accordance with the Declaration of Helsinki, from first consideration of need and justification through publication of results.

National or imported prototype devices and controlled technology biomedical equipment may be authorized exclusively for research and experimentation and may never be used in healthcare delivery; import requires ANM authorization under health research rules.

Devices strictly for research or clinical trial are exempt from notification/registration but require a Certificate of Medical Device Listing, applied for before importation; Class B/C/D technical requirements follow the CSDT template (which structures clinical evidence within the dossier).

Clinical investigation applications (MDR Art. 70(1)) and related notifications to URPL are made in Polish or English, except participant facing information and documents and the investigation summary, which must be in Polish; URPL's service page confirms use of the MDCG 2021 08 application documents and acceptance by e Doręczenia, post or in person.

A URPL clinical investigation permit may be issued only after a positive opinion of a bioethics committee (or the Appeal Bioethics Committee); the committee must issue its opinion within 45 days of a complete application; in multi centre studies the committee competent for the coordinating investigator's site covers all sites, and other committees have 14 days to object; an appeal from the opinion lies to the Appeal Bioethics Committee.

A sponsor intending to conduct a post market clinical follow up investigation in Poland (MDR Art. 82(1)) must apply to the President of URPL for a permit; the application follows the MDR Art. 70 procedure and omits Annex XV sections 1.5, 1.15 and 3.1.1.

IVDR performance studies follow the same national procedure as clinical investigations: a bioethics opinion (45 days) is required first; URPL decides within 45 days of validation, extendable by 20 days for expert consultation (substantial modifications: 38 days, extendable by 7); the application is in Polish or English with participant documents in Polish; a fee applies; a sponsor conducting a performance study other than under Art. 39 must notify URPL within 7 days of starting it.

INFARMED is responsible for decisions on clinical investigation applications and notifications; the CEIC (Comissão de Ética para a Investigação Clínica) is the ethics committee competent for the ethics assessment under MDR Chapter VI and IVDR Chapter VI, and its opinion is binding and incorporated in the decision.

Clinical investigations of devices without CE marking, or CE marked devices used outside the intended purpose, follow the MDR Art. 62 authorization regime; investigations of CE marked devices within the intended purpose (participant inclusion not fixed by protocol, per Art. 40(2)) follow the MDR Art. 74 notification regime.

Clinical investigation applications/notifications are submitted through the EU electronic system of MDR Art. 73 or, for the national routes of Lei 71/2025 Art. 5, through INFARMED's national electronic system, with the full Annex XV Chapter II documentation; IVD performance study applications go through the IVDR Art. 69 system.

Clinical trials in Qatar may only be conducted through a licensed research institution, and a licence from the Ministry of Public Health's competent administrative unit (الإدارة), based on the approval of the National Committee for the Ethics of Health Research, is required for any of the following: a clinical trial of a medical product not registered in the State; a clinical trial of a medical product registered in the State that is examined in a manner inconsistent with the registered standards, for example through a new route or dose; a clinical trial of a combination of registered pharmaceutical preparations; and a medical procedure not used in the health facility in which the trial is conducted. Being granted the status of principal investigator for those trials likewise requires a licence from the Administration on the National Committee's approval, and health research generally may not be conducted except through a research institution and after the approval of one or more human, animal or laboratory research review committees.

ANMDMR approves clinical investigation applications only if accompanied by the ethics opinion of the National Bioethics Commission for Medicines and Medical Devices (CNBMDM), whose composition and rules are approved by Order of the Minister of Health no. 80/2023.

The clinical investigation application is registered only if accompanied by proof of payment of the tariff under OMS 3467/2022 (Annex 1 point 3).

National conformity assessment is performed in the form of technical tests, toxicological studies and clinical trials per Minzdrav Order No. 885н of 30.08.2021; trials are conducted at organizations meeting the requirements of Minzdrav Order No. 300н of 16.05.2013; time for clinical trials is excluded from the review clock.

Registration of a medical device in Rwanda requires an overall clinical evidence submission. ToC section 4.02 ('Overall Clinical Evidence Summary') requires a brief one to two page summary of the available clinical evidence presented in support of the submission, listing the evidence presented and its characteristics (RCT, case study, literature review, post market data from another jurisdiction or from a marketed device) with a discussion of how it is considered sufficient to support the marketing request for the requested indications; a tabular listing of clinical studies may be included; where any study device differs from the device to be marketed, including a competitor's device, the applicant must describe those differences and their impact on the validity of the evidence, which may include a detailed comparison of the clinical, technical and biological characteristics of the two devices; and human factors testing that includes patients is filed here. Section 4.02.01 ('Clinical Evaluation Report') requires a clinical evaluation report reviewed and signed by an expert in the relevant field containing an objective critical evaluation of all clinical data submitted in relation to the device, together with a complete curriculum vitae or similar documentation justifying the manufacturer's choice of clinical expert. Section 4.02.02 ('Device Specific Clinical Trials') requires clinical trial information grouped by trial, beginning with trial description, protocol number and date of initiation, followed by a clinical trial summary and clinical trial report; raw data may be requested by the Authority (4.02.02.01.03). Section 2.07 ('Post Market Study Plans') requires the applicant to provide post market study plans, which may include clinical or non clinical study plans, on study objectives, study design, subjects and sites, endpoints (primary and secondary), summary of the data analysis plan, and length and frequency of follow up, excluding final reports and analysis. Investigations on human subjects are regulated through the separate clinical trial framework: art. 35 of TRG/002 provides that 'these regulations shall not apply to devices intended to be used in research and development studies, without prejudice to the provisions of the regulations on clinical trials in force', and the import/export guideline allows a special import authorisation for unregistered devices to be used in a clinical trial, on production of a clinical trial approval certificate or ethical committee approval/certificate (or, for veterinary research, approval from government institutions), with an application form FDISM/FDIEC/FOM/003.

The MDMA technical documentation must include the clinical evaluation report, its updates and the clinical evaluation plan per Annex 6 (with PMCF plan/evaluation report where applicable). Local clinical trials or IVD performance studies require prior SFDA approval based on an approved Clinical Investigation Plan and IRB/Ethics Committee approval, appointment of a full time Saudi national responsible for clinical trials (bachelor's degree and 3+ years experience), and an SFDA import permit for trial devices; completion, major deviations and safety/rights occurrences must be notified within 5 days.

Décret n° 2023 2419 makes clinical evidence an element of the essential requirements for every medical device. Annexe 1 (the essential requirements, made an integral part of the decree by art. 44) provides at B14.1 that for all medical devices 'la démonstration de la conformité aux principes essentiels comprend une évaluation clinique conforme aux directives de l'autorité compétente' (demonstration of conformity with the essential principles includes a clinical evaluation in accordance with the directives of the competent authority), and that the clinical evaluation should examine clinical data in the form of clinical investigation reports and of literature reviews and clinical experience, in order to establish that the device presents a favourable benefit/risk ratio. B14.2 governs investigations on human subjects: they 'devrait être réalisée conformément à l'esprit de la Déclaration d'Helsinki', covering every stage from consideration of the need for and justification of the study through to publication of the results, with the further caveat that some countries may have specific regulatory requirements for protocol review before the study or for informed consent. The labelling requirements of the same annex require devices intended for clinical investigations to carry the mark 'exclusivement pour investigations cliniques' (B13.1, item h). The clinical trial decree of the same date, Décret n° 2023 2422, is not the instrument for device investigations: its Article 2 defines 'essai clinique' as 'étude systématique des produits pharmaceutiques sur des sujets humains' (a systematic study of pharmaceutical products on human subjects). Performance data and validation requirements sit in sections B1 to B13 of the same annex, and the technical documentation that must underpin the evaluation is required by art. 34 to be drawn up 'dans la langue officielle nationale'.

A clinical investigation of a medical device may be conducted only if the benefit exceeds the potential risk to subjects, ALIMS has approved the conduct, and the Ethics Committee of Serbia has given a positive opinion (given in a parallel procedure); informed consent (written, signed, dated) is required, and the trial may be performed only at a healthcare institution contracted with the sponsor, by employed healthcare professionals, with records kept at least five years after trial end.

ALIMS must approve a clinical investigation within 40 days of receipt; if the application is incomplete ALIMS notifies within 5 days and the applicant completes within 20 days; the 40 day clock stops while supplementation is requested. The Ethics Committee of Serbia gives its opinion in a parallel procedure within 30 days (15 day supplementation, stop clock). Approvals are published on the ALIMS website within 7 days.

In clinical investigations, the sponsor reports to ALIMS a serious adverse event requiring prompt corrective measures for other subjects/users, and new findings on such an event, within 2 calendar days of awareness; other reportable events within 7 calendar days. The investigator reports events to the sponsor per the approved protocol, at the latest 3 calendar days from awareness. Post market non interventional studies fall under the vigilance system.

After the scope is defined, a clinical evaluation has three stages: identification of pertinent standards and clinical data; appraisal of each data set for relevance, applicability, quality and clinical significance; and analysis of those data sets to reach conclusions about performance, safety and presentational aspects (labelling, patient information and IFU). A report is then prepared and combined with the other technical documentation.

Sponsors must ensure devices in clinical research are used only for the clinical purpose and, where the research requires institutional review board approval, with that approval; unused devices must be disposed of or exported within 6 months after the conclusion or termination of the research unless the Authority allows otherwise; offences up to $20,000/12 months.

Unregistered devices may be supplied where the planned use is a clinical purpose in clinical research (reg 10A), with prior notice to the Authority under reg 51 from the manufacturer; such devices may only be supplied or used for that clinical purpose or another purpose the Authority has allowed, on pain of fine up to $20,000 and/or 12 months' imprisonment (regs 13A, 36A).

ŠÚKL will not issue the clinical investigation authorisation decision without a positive ethics committee opinion, and a clinical investigation may not start without it; the opinion is submitted as soon as available. Until the EUDAMED clinical investigation module is fully functional, applicants use local ethics committees in Slovakia.

A clinical investigation of a medical device, or a performance study of an IVD, conducted in Slovakia requires prior authorisation from ŠÚKL: application on form TL SZP 021 (clinical investigation) or TL SZP 066 (IVD performance study) per ŠÚKL methodological guideline MP 147/2024. The investigation may start only after the authorisation decision (Rozhodnutie) becomes final; if the application is refused the 500 € administrative fee is not returned.

The sponsor and the researcher must insure their liability for any damage a participant may suffer due to participation, before a clinical investigation or performance study conducted in Slovenia begins; no minimum coverage amounts are prescribed.

JAZMP is the authority approving clinical investigations under Art. 70 MDR; after validating scope (Art. 62) and completeness (Annex XV ch. II), JAZMP and the Medical Ethics Commission (KME) jointly assess applications under Art. 71 MDR; KME delivers its opinion to the sponsor and JAZMP within 30 days of the validation date; point (a) investigations may start immediately after validation, point (b) after JAZMP approval notice, provided KME gave no negative opinion.

For IVDR Art. 58 performance studies, JAZMP verifies scope and completeness (Annex XIV ch. I) and informs the sponsor per Art. 66(1); for point (b) studies JAZMP and KME assess jointly under Art. 67 IVDR; KME delivers its opinion within 30 days of validation; point (a) studies may start only after 30 days from validation, point (b) after JAZMP approval notice, in both cases absent a negative KME opinion.

A person may not conduct a clinical investigation, clinical trial or clinical performance assessment for an IVD without Council authorisation; the investigator must be appropriately qualified, approved by the Council and resident in the Republic, the study must follow good clinical practice guidelines determined by the Council, progress reports are due every six months and 30 days after completion or termination, and adverse event reports immediately or as soon as practically possible; investigational devices must be labelled 'for investigational use only'.

Devices that are not substantially equivalent, or for which clinical trial data submission is required, need approval (even in Class 1 2) with clinical data; e Medis shows the approval clock for clinical data cases at 80 days versus 65 days for technical document only cases.

Clinical trials of medical devices run under an MFDS approved clinical trial plan (임상시험계획 승인); investigational devices must be manufactured in facilities meeting Prime Ministerial Decree standards (or imported correspondingly).

The sponsor applies to AEMPS for clinical investigation authorization (application, investigator's brochure, plan, informed consent and investigational device labelling/instructions at least in Spanish); investigational products may only be made available to practitioners if the investigation has the favourable opinion of an accredited CEIm ethics committee, whose single binding opinion can be obtained in parallel but must reach AEMPS before authorization and within the 45 day period.

Investigations with CE marked devices within their intended purpose involving additional invasive or burdensome procedures (MDR art. 74(1)) are notified, not authorized, in Spain via the AEMPS NEOPS database; investigations with CE marked devices outside their intended purpose (MDR art. 74(2)) follow the same procedure, documentation and timelines as full applications; CE marked device investigations without such additional procedures require neither AEMPS authorization nor notification.

The sponsor of a clinical investigation must take out insurance or a financial guarantee covering the liability of investigators and sponsor; the minimum coverage is EUR 250,000 per subject in the investigation, with a maximum of EUR 2,500,000 per investigation and per year. IVD performance studies carry the same minimums under RD 942/2025 arts. 26 27.

IVD performance study authorization is requested from AEMPS with timelines per Article 66 of Regulation (EU) 2017/746; the single binding ethics opinion comes from one CEIm in Spain (multicentre studies); study devices must be provided free of charge by the sponsor; and the sponsor needs insurance/guarantee of at least EUR 250,000 per subject (up to EUR 2,500,000 per study and year).

End user evaluation is waived for applications processed under the Reliance Pathway, and low risk devices (listed, non sterile/non active/non measuring Class I and Class A IVD) are exempt from end user performance evaluation; non reliance applications otherwise require samples via the Sample Import Licence upon NMRA request.

NMRA decided to use the regulatory reliance principle and exempt performance evaluation (clinical evaluation/sample evaluation) to expedite registration: one year provisional registration for IVD new applications approved by WHO or WHO reference regulatory authorities (FDA USA, TGA Australia, Health Canada, HSA Singapore, MHLW Japan); one year conditional provisional registration with pending performance evaluation for COVID 19 essential non IVD devices approved by an NMRA reference country; renewal applications for registered devices without complaints or quality issues are also exempt.

A fee must be paid by anyone applying to conduct a clinical investigation of a medical device or a performance study of an IVD with Läkemedelsverket, and by applicants for other device related decisions (annual fees, export certificates); amounts are set in förordning (2021:988).

Applications and notifications for clinical investigations of devices (MDR) and performance studies of IVDs (IVDR) in Sweden are sent to Läkemedelsverket, which forwards them to Etikprövningsmyndigheten (Swedish Ethics Review Authority); the Ethics Review Authority always performs an ethics review of the application or notification.

Demonstration of compliance with the general safety and performance requirements includes a clinical evaluation in accordance with Art. 61 EU MDR (incorporated by reference into the MedDO).

Clinical investigations with medical devices are categorised under KlinV Mep: category A (subcategories A1/A2) — CE marked device used per its instructions for use and not banned in Switzerland; category C — CE marked off label use (C1), non CE device (C2), banned device (C3). Category A investigations are exempt from the Swissmedic approval requirement under TPA Art. 54(1); for category C, the reports and notifications under Arts. 35 37 KlinV Mep must also be submitted to Swissmedic.

Sponsors must define, execute and manage the clinical trial and ensure data integrity and subject rights, safety and welfare (GCP Regulations Art. 5; investigator initiated trials are subject to the same sponsor rules, Art. 24). For multicentre trials the sponsor must appoint a lead principal investigator and allocate responsibilities in writing (Art. 12).

Sponsors or trial institutions must obtain central authority approval before starting a medical device clinical trial; announced non significant risk device trials are exempt from prior approval. The trial plan must also be approved by the institutional review board: the sponsor prepares the clinical trial plan, which may only be executed after approval by the review committee (審查會) and the central authority.

During clinical trials, where a device defect could cause a serious adverse reaction, the sponsor must notify the central authority within 7 days of learning the facts and submit detailed investigation data within 15 days; investigators must immediately notify the trial institution, sponsor and review committee with a written report. For trial subject serious adverse events (death, life threatening, disability, congenital malformation, hospitalisation), reports are due within 7 days with detailed data within 15 days (Act Art. 38).

A clinical trial application must be in the prescribed form, signed, accompanied by the prescribed fee, an Ethical Clearance Certificate issued by an approved institute for medical research, and relevant information per the clinical trial guidelines.

Where proof of clinical performance is required, clinical evidence must be submitted as part of the registration dossier; a clinical evaluation considers available relevant clinical data from published sources or device related investigations, and additional clinical data may need to be generated for certain devices.

No person may conduct a clinical trial of any medical device without the written authorisation of the Director General of TMDA.

Clinical investigations of medical devices in Thailand must follow ISO 14155:2020 or ISO 20916:2019, as applicable.

Devices whose clinical data are insufficient to demonstrate compliance with the essential principles of clinical safety and performance require clinical investigation data for the clinical evaluation supporting a licence or detailed notification application; such studies are conducted under IDE permission.

ANMPS is the body charged with framing and issuing the authorisations needed to conduct clinical trials on medicines, medical devices and other health products. Sponsors, investigators and clinical research organisations must submit a complete dossier containing the study protocol, information on the product studied and the documents relating to patient safety; a rigorous evaluation is carried out before any approval, in collaboration with experts in ethics and clinical methodology. The documented decision chain is: online filing of the dossier; validation of the contract by all the entities concerned; opinion of the president of the CPP (personal protection committee) or of the ethics committee for non medicinal products; opinion of the president of the INPDP; opinion of ANMPS and external experts; validation of the clinical trial registration or rejection of the application; notification of the applicant and the stakeholders.

After receiving an application, the Kurum notifies the sponsor within 10 days whether the clinical investigation falls within the Regulation's scope and whether the application file is complete per Annex XV Section II; the sponsor may object through the Kurum's objection procedure.

Clinical investigations are reviewed by an ethics committee from the list established with Kurum approval and published on the Kurum website; at least one lay member serves in the ethical review.

Uganda routes clinical requirements through the IMDRF Essential Principles checklist that DAR/GDL/028 Appendix II adopts. Essential Principle 7.0 provides that every medical appliance requires clinical evidence, appropriate for the use and classification of the appliance, demonstrating that the appliance complies with the applicable provisions of the essential principles, and that a clinical evaluation should be conducted. Essential Principle 18.1 provides that clinical investigations on human subjects should be carried out in accordance with the spirit of the Helsinki Declaration, which includes every step in the clinical investigation from first consideration of the need and justification of the study to publication of the results. Operationally, DAR/GDL/028 s. 4.3.2(i) lists 'Performance & Safety clinical studies (where applicable, upon request)' among the registration requirements for high risk surgical instruments and appliances, and s. 4.12.3(c) requires a Track 3 applicant to file 'Summary information on pre clinical design verification and validation' as Appendix I item 2 part p. NDA's classification page points to the UNBS webstore for the surgical instrument standards it applies.

The manufacturer or its authorized representative must notify Держлікслужба about the completion of clinical investigations (with justification where they were terminated early) and keep the report per Annex 10 point 9, giving market surveillance authorities access on request.

Conformity with the essential requirements must necessarily include clinical evaluation in accordance with Annex 10 to TR 753; for the relevant procedure the manufacturer applies the Annex 10 procedure and notifies Держлікслужба by a statement per Annex 10 point 2.

Clinical trials require prior non clinical studies to initially confirm the safety and effectiveness of the intended intervention. Article 25(2) excepts compassionate use subject to Executive Regulation controls. Clinical research follows the terms, controls and procedures issued by the Cabinet.

The manufacturer must notify the Secretary of State of the end of the clinical investigation and justify any premature termination; sponsors must notify MHRA of early termination with justification, temporary halts must be notified, and the end of study report is emailed to MHRA's clinical investigation applications mailbox.

Devices already UK marked (CE marked for the Northern Ireland version) do not require clinical investigation notification unless the aim of the intended investigation is to determine whether the device may be used for a purpose other than that for which it was marked.

Great Britain operates a 60 day notification (not approval) regime for clinical investigations: the manufacturer or UK responsible person gives at least 60 days prior written notice to the Secretary of State, including the Annex VIII statement and an undertaking to keep the Section 3.2 documentation available for at least five years; the Secretary of State may within 60 days notify that the device should not be made available on public health or public policy grounds, or issue a (possibly conditional, withdrawable) permit; investigations must be conducted in accordance with Annex X.

Clinical data submitted in a 510(k) must meet 21 CFR 807.87(j); for clinical investigations conducted outside the United States, the submission must include the investigator and study site information required by 21 CFR 812.28 (21 CFR 807.87(j)(2)).

PMA clinical investigations (21 CFR 814.20(b)(6)) must comply with 21 CFR parts 50 (informed consent), 56 (IRBs), and 812 (IDE); investigations conducted outside the United States must include the information required by 21 CFR 812.28, and financial interests of investigators must be disclosed under 21 CFR part 54.

The dossier must describe the safety and efficacy (essential requirements) of the product; where this description does not demonstrate safety and efficacy, the sanitary authority may require clinical investigation at the charge of the importer or manufacturer.

Devices are registered based on the positive results of clinical studies (PF 137); the Regulation exempts from clinical studies: class I devices; WHO prequalified IVDs registered in cooperation with WHO; devices whose clinical studies were previously conducted in Uzbekistan; and recognition route devices. The dossier for classes IIa, IIb and III must contain a clinical efficacy and safety report; the Centre determines study types and clinical bases, evaluates programs/protocols and sends a binding instruction via the information system. For class I, clinical efficacy documentation is not required except for sterile, measuring and invasive devices.

Clinical investigations of medical devices operate under an MOH approval regime: dossiers for approval and for amendments to approved trials (phê duyệt thay đổi thử nghiệm lâm sàng) are prescribed; scope/timelines not extracted.

statement: The non IVD dossier contains a dedicated Chapter 4 on Clinical Evidence, and the guideline's Annex I form requires the applicant to declare whether there have been previous recalls, reportable adverse incidents, banning in other countries or post market surveillance studies, attaching relevant documentation. The Essential Principles of Safety and Performance of Medical Devices (ZAMRA/MA/GUD/0001) is published by ZAMRA as the conformity standard against which safety and performance are assessed, and the dossier also requires an Essential Principles checklist and a declaration of conformity. IVD grant of marketing authorisation requires the Authority to be satisfied that the product conforms with the Essential Principles of Safety and Performance.

A condom is defined in Zimbabwean law as a medical device intended to be worn on the penis during sexual activity for the purposes of contraception and to prevent the spread of sexually transmitted infections. MCAZ may not approve a condom unless it meets the standards set out in the Second Schedule to the Condom Regulations, or as specified by the Authority in guidelines from time to time. The Second Schedule's performance requirements are burst volume and burst pressure before and after oven conditioning, freedom from holes, and visible defects, in each case verified by laboratory testing against ISO 2859 1 sampling plans with stated acceptance quality limits (AQL 1.5 for burst volume and burst pressure, AQL 0.25 for freedom from holes, AQL 0.4 and AQL 2.5 for visible defects). Approval is granted for a type and brand, and each batch must separately be approved for distribution before it may be sold.

MCAZ's clinical trial guideline (MCAZ/PVCT/GL 04 Rev 2, August 2024) describes MASCA as defining a clinical trial as a systematic study done in human beings or animals in order to establish the efficacy of, or to discover or verify the effects or adverse reactions of, medicines or medical products, and as requiring the Authority's prior written authorisation, granted with the approval of the Secretary for Health and Child Care, before any clinical trial of a medical product. The consolidated Act itself is narrower in its wording: s.2 defines 'clinical trial' by reference to 'medicines' and s.16(1) prohibits conducting a clinical trial 'of any medicine' without the Authority's prior written authorization granted with the approval of the Secretary. Review and approval is expected to take up to 60 working days from receipt of a complete application package by MCAZ's Pharmacovigilance and Clinical Trials Division, excluding the time the applicant spends answering queries; for clinical trials for emergency preparedness the expedited timeline may be reduced to 15 30 working days, subject to early submission of a complete application. Applications are submitted through the Electronic Clinical Trials Registry System at https://e ctr.mcaz.co.zw/, and after approval the principal investigator reports adverse events, AEFIs and serious adverse events through the Electronic Pharmacovigilance system at https://e pv.mcaz.co.zw/.