Standards, testing & ancillary approvals by country

For medical devices not registered in Armenia, Annex 2 requires a copy of marketing authorisation (state registration or free sale authorisation) from the manufacturer’s country or an IMDRF member country, or the specified substantiated alternative including conformity declarations and registry information. A batch quality certificate is required where applicable. For used or refurbished devices, the manufacturer or authorised repair provider must additionally document the work performed and provide the post work safety, quality and effectiveness conclusion, such as a certificate, declaration or final test report.

Armenian law requires that medical device manufacture in Armenia is carried out according to ISO 13485, that the manufacturer implements and maintains a quality management system with assessment, and that manufacturers of class 2a (sterile), 2b and 3 devices undergo an expert inspection every three years.

Medical devices manufactured in Azerbaijan or imported into the country are certified, in the manner established by legislation, by the accredited conformity assessment body of the relevant executive authority or by other accredited conformity assessment bodies. Accreditation of those bodies is carried out under the Law on Accreditation in the Field of Conformity Assessment.

Among the powers of the relevant executive authority under the Law on Medicinal Products is to prepare, and approve within its competence, technical normative legal acts and state standards relating to medical devices (Art. 4.2.8). The Law defines the certificate of a medical device as the document confirming the device's conformity with the requirements of the relevant technical normative legal acts (Art. 1.0.13), and device quality as conformity with those acts and with the manufacturer's documents issued under them (Art. 1.0.14).

Where the documents submitted for state registration of a device made from natural or synthetic substances and their compounds in a dosed pharmaceutical form contain information about a medicinal substance, the device must, before state registration, be examined by the Analytical Expertise Centre to establish the quality, efficacy and safety of the medicinal substances it contains; the expertise is carried out under the Rules approved by Cabinet Decision No. 502 of 25 December 2019.

Before state registration of a device made from natural or synthetic substances and their compounds in a dosed pharmaceutical form, the Analytical Expertise Centre carries out an expertise of the documents and laboratory analyses of product samples to establish the quality, efficacy and safety of the medicinal substance it contains. The applicant must submit with the application the packaging artwork, the instructions for use with a notarised Azerbaijani translation, the manufacturer's composition document with quantities and a notarised translation, the device's certificate of analysis for each batch including the analytical methods, proof of registration in any country (except for devices made in Azerbaijan) and three samples of the device.

For sterile medical devices the dossier must include a notarially certified Azerbaijani translation of a manufacturer's document reflecting: the methods of conducting tests and the validation of packaging; test results for microbiological content (degree of bioburden), pyrogenicity and sterility; and data on process validation. The manufacturer's biological safety information is required for every device that contacts the intended user's body (waived for non contacting devices).

NHRA registration dossiers must include an ISO 13485 quality management system certificate for the physical manufacturer (address matching the relationship letter) and a quality assurance certificate — CE under Directives 93/42/EEC or 98/79/EC or Regulations (EU) 2017/745 or 2017/746 or an FDA Certificate to Foreign Government — for the legal manufacturer, both with verification evidence. Class III devices and class D IVDs additionally require an EC Design Examination certificate or FDA CFG, and class I non sterile and Class A/others IVD are exempt from the QAC.

Part B of the ALMBIH registry entry document checklist lists ISO 9001:2015 and ISO 13485:2016 under quality system certificates, with an exemption for Class I medical devices. Part C separately specifies EC conformity assessment certificates by device category, and the Declaration of Conformity must identify the device class.

Appendix B of BoMRA's Essential Principles guideline is a table of 'Relevant Standards' per essential principle, described as general, non exhaustive guidance: for 5.1 (general) ISO 13485, ISO 14971, ISO 23640, ISO 24971 and CLSI EP25; for 5.2 (clinical evaluation) ISO 14155; for 5.3 (chemical, physical and biological properties) ISO 10993, IEC 60601 and IEC 61010; for 5.4 (sterilisation and microbial contamination) ISO 11135, 11137, 11138, 11140, 11607, 10993, 11737, 13408, 14644, 14937, 14698, 17664 and 17665; and for 5.5 (environment and conditions of use) IEC 60601, IEC 61010, IEC 62366 1, IEC/TR 62366 2, IEC 80001 and ISO 80369.

In the registration dossier's 'Certificate of Compliance with Recognized Standards' section the applicant should submit the applicable product certificate, a TSE/BSE risk free attestation letter, the standards used for sterilisation (such as ISO 11135, ISO 11137, ISO 17665, ISO 13408) with information on the sterilisation method(s), and a certificate of conformity in line with the declaration of conformity. For IVDs the same section additionally asks for the applicable certificate of GMP.

Evidence of conformity to the Essential Principles of Safety and Performance must be provided by completing BoMRA's Essential Principles checklist. Where national, international or other standards are used to demonstrate conformity, the full title of the standard, its identifying number, its date and the organisation that created it must be given.

BoMRA's registration guideline defines Recognized Standards as national or international standards deemed to offer the presumption of conformity to specific essential principles of safety and performance. The clinical evaluation guidance uses the same definition. BoMRA publishes no closed list; the applicant names the standards applied in the Essential Principles checklist.

Where a device contacts the patient, biocompatibility of all potentially patient contacting materials is required. Tests should be run on samples from the final product after all manufacturing and processing, including sterilisation; deviations must be justified and generic raw material supplier claims are generally insufficient. Reports must give, for each test, the predefined acceptance criteria and results. ISO 10993 standards are taken as the gold standard; if testing was not done to a currently recognised standard, the validated alternative method and a justification (for example for nanotechnology devices) must be provided, and deviations from a standard method specified.

Donated medical devices must obtain port clearance from BoMRA and be accompanied by a valid import certificate, packing list, proforma invoice, airway bill or bill of lading, a certificate of refurbishment for used devices (issued by the manufacturer or a certified company), and a certificate of analysis for sterile medical devices. Donated X ray equipment must be calibrated and inspected by a qualified medical physicist or certified by an approved radiation body.

The only standards provision in Brunei health product law is s. 35 of the Medicines Act, which requires a medicinal product sold under a monograph name to comply with the monograph in the British, European or United States Pharmacopoeia or other named publications. No Brunei instrument recognises ISO, IEC or other standards for medical devices, and no device testing or certificate is required by the Ministry of Health.

Article 6 of Prakas 1258 lists the visa registration dossier for devices in classes B, C and D: the application (on the model form), a GMP certificate or an international standard (ISO) certificate (original or certified copy), the original free sale certificate from the country of origin, registration certificates from other countries (if any), the analysis bulletin issued by the manufacturing establishment, the technical documents of Annex 2, and two samples or catalogues. Article 5 lists the class A dossier without the analysis bulletin, the technical file or foreign registration certificates.

The DDF sample application letters for device/reagent registration, renewal and visa list among the mandatory attachments a quality analysis bulletin issued by the National Health Product Quality Control Centre (ព្រឹត្តិបត្រវិភាគគុណភាពចេញដោយមជ្ឈមណ្ឌលជាតិពិសោធន៍សុខាភិបាល) for disinfectants, and a Declaration of Conformity (DoC) together with the Certificate of ISO/GMP.

Under the UEMOA guidelines applied by AIRP, a 'certificat de conformité' is the written attestation issued by a conformity assessment body recognised by the competent authority stating that the manufacturer correctly applies the essential requirements for medical devices, whereas a 'déclaration de conformité' is the manufacturer's own written attestation that it has applied the conformity assessment elements matching the device's class. A conformity assessment body (OEC) is a body other than a regulatory authority charged with determining whether the relevant requirements of regulations or technical standards are met.

The electronic technical dossier for an Autorisation de Commercialisation must include documentation comprising a checklist demonstrating the device's conformity with the essential requirements of quality, safety and performance together with the corresponding standards and the reference to the internal documents used, and, where necessary, documentation indicating the requirements that do not apply to the device concerned.

The device declaration form annexed to the UEMOA guidelines, on which the AIRP listing declaration is based, requires that a copy of the certificate of conformity issued by a recognised authority be attached for devices of class B, C or D; class A devices are declared without such a certificate.

Loi n° 2017 541 requires AIRP, for the quality control of pharmaceutical products, to use the Laboratoire national de la Santé publique and all other competent structures of the ministry in charge of health, and allows it, where needed, to contract with any other competent quality control laboratory that complies with the rules and standards of good laboratory practice in force. The opening and operation of any quality control laboratory for pharmaceutical products is subject to an authorisation issued by AIRP.

The UEMOA guidelines provide that the commissioning of certain high risk devices, notably those of classes C and D, may require a technical evaluation before the device is put into operation. A document certifying the device's conformity is attached to the applicant's commissioning request to the national regulator, and where necessary the commissioning may be carried out by the regulator at the applicant's expense.

The application must include three samples of the definitive sale model presented in French, with at least twelve months of remaining validity, accompanied by certificates of analysis. On the opinion of the expert committee an additional technical evaluation may be required, in which case the evaluation fees are set according to the evaluation protocol required and are borne by the applicant.

Devices in conformity with the relevant harmonised standards, or the relevant parts of them, whose references have been published in the Official Journal of the European Union are presumed to conform to the requirements of Regulation (EU) 2017/745 covered by those standards. The presumption also covers system or process requirements on economic operators or sponsors, including quality management, risk management, post market surveillance, clinical investigations, clinical evaluation and post market clinical follow up. The Croatian implementing act contains no standards provision, so this directly applicable Union rule is the operative one.

CYMDA states that the conformity of a product with the relevant legislation may be presumed to a degree where the product corresponds to the relevant harmonised European standards, giving EN ISO 13485:2016 as an example, and it links to the list of harmonised standards.

Devices with a measuring function must be operated (and serviced, § 44(2)) in compliance with the metrology legislation — Act No. 505/1990 Sb. on metrology and Vyhláška No. 345/2002 Sb. on measuring instruments subject to mandatory verification (e.g. eye tonometers, blood pressure monitors, audiometers, scales, electric clinical thermometers); verification of such instruments is performed by the Czech Metrology Institute (ČMI) or an authorised metrology centre.

Denmark applies the EU RoHS restriction on hazardous substances in electrical and electronic equipment through BEK nr 1369 af 02/12/2024 (issued under the chemicals act), which covers EEE in the Annex 1 product categories — including medical devices (the regulation itself defines active implantable medical devices by reference to MDR). DKMA lists this regulation in its medical device legislation overview.

Resolución 000011 (25 July 2017) defines sanitary notification as a sworn declaration procedure to update a valid registration and lists among eligible updates the quality control method and finished product specifications for medicines, cosmetics, hygiene products, productos sanitarios, natural products and foods, provided the approved guarantees of identification, quality, purity and stability are not modified; DIGEMAPS denies notifications not accompanied by the required documents (SÉPTIMO).

Devices conforming to the relevant harmonised standards, or the relevant parts of them, whose references have been published in the Official Journal of the European Union are presumed to conform to the requirements of Regulation (EU) 2017/745 covered by those standards. The presumption also covers system or process requirements for economic operators, including quality management systems, risk management, post market surveillance, clinical investigations, clinical evaluation and PMCF.

The technical section of the registration dossier must list the standards complied with in full or in part in the design and manufacture of the device, giving at minimum the standards organisation, number, title, year/version and whether compliance is full or partial; for partial compliance the applicant lists the sections not applicable, adapted or deviated from, with a discussion. Conformity with the Essential Principles may be demonstrated by conformity with recognised or other standards, industry test methods, in house test methods, pre clinical and clinical evidence, or comparison to a similar marketed device.

The IVD registration dossier must list the standards complied with in full or in part in the design and manufacture of the device, stating at minimum the standards organisation, number, title, year/version and whether compliance is full or partial, and for partial compliance the sections not applicable, adapted or deviated from, with an accompanying discussion.

An application is rejected at screening or evaluation if the device is found not to fulfil the critical safety or performance parameters required in a relevant recognised standard, or if actual product samples requested for laboratory testing are not provided within six months of the request. EFDA may therefore request physical samples for laboratory testing as part of the review.

Use of harmonised standards is voluntary: devices in conformity with relevant harmonised standards (or parts) whose references are published in the OJEU are presumed to conform with the MDR requirements they cover; this also applies to system/process requirements for economic operators (QMS, risk management, PMS, clinical evaluation/PMCF) (Art. 8(1) MDR). Equivalent rule for IVDs: Art. 8 IVDR.

Radiation safety of the use of devices producing ionizing radiation (radiation devices, radioactive substances and radiation practices) is additionally governed by the Radiation Act (859/2018); devices producing non ionizing radiation and devices equated with them by operating principle are also covered insofar as they cause population exposure to radiation.

Clinical investigations of medical devices, including all measures relating to the protection of investigation subjects, must be conducted in accordance with the provisions of the Helsinki Declaration (adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964) as subsequently amended, and with the International Conference on Harmonisation (ICH) guideline for Good Clinical Practice (GCP) and the International Organization for Standardization guideline 'Clinical investigation of medical devices for human subjects' (ISO 14155:2020) as subsequently amended. The clinical investigation plan and protocol must be drawn up to the GCP standard, and the investigation rules must conform to the ethical principles of the final version of the Helsinki Declaration.

After registration, any imported condom consignment is detained, sampled and analysed on a batch to batch basis and released only if it passes quality evaluation at the FDA Medical Devices Laboratory.

Devices in conformity with the relevant harmonised standards, or the relevant parts of them, whose references have been published in the Official Journal of the European Union are presumed to conform to the requirements of Regulation (EU) 2017/745 covered by those standards. The presumption also covers system or process requirements on economic operators or sponsors, including quality management, risk management, post market surveillance, clinical investigations, clinical evaluation and post market clinical follow up. Act No. 132/2020 contains no Icelandic standards provision, so this Union rule is the operative one.

COSQC examines samples of imported goods referred by the General Customs Authority, the Ministry of Health and other ministries; it operates a pre shipment inspection and testing program before supply in the country of origin or export, and runs a dedicated conformity assessment department for imported goods (قسم تقويم المطابقة للسلع المستوردة).

A medical device in use must undergo, once a year, the electrical safety and functional tests listed in Annex 2 of Regulation No. 461 if at least one of three conditions holds: the active class IIa, IIb or III device is not CE marked; no manufacturer documentation is available on the electrical safety or functional tests to be performed or their intervals; or the services of the manufacturer, its authorised representative or its representative (distributor) are not available in Latvia. Annex 2 Table 1 lists the parameters (protective conductor resistance, protective conductor leakage current, enclosure leakage current, patient leakage current for CF and BF types) and the measurement conditions; Part II adds functional tests for devices generating electrical energy for nerve, muscle or cardiac stimulation.

statement: Devices that conform to the relevant harmonised standards, or parts of them, whose references have been published in the Official Journal of the European Union, are presumed to conform to the requirements of Regulation (EU) 2017/745 covered by those standards. The same presumption applies to system or process requirements, including those relating to quality management systems, risk management, post market surveillance, clinical investigations and clinical evaluation. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: No

Under Decision No. 455/1 the Industrial Research Institute (معهد البحوث الصناعية) is the body accredited to issue all the conformity certificates required by Article One for imported medical equipment, instruments and supplies, conformity being verified through the mechanism of Decree No. 5305 of 28 October 2010 (Article Three); it is also the issuing body for conformity to Lebanese or reference international specifications for national products and for products imported from countries outside the reference list (Article Six).

The Lebanese Standards Institution (LIBNOR) has for some years adopted European standards relating to medical devices as national standards and is working to make them mandatory through publication of the corresponding decrees. In evaluating a registration dossier, the health technology unit forms its own decision taking into account the standards adopted by international and local institutions (LIBNOR, etc.) concerning the device in question, where applicable.

Under Decision No. 455/1 of 16 April 2013, Article One, a conformity certificate is imposed on all imported medical equipment, instruments and supplies; mandatory Lebanese standards are adopted where they exist, and where they do not exist the non mandatory Lebanese standards or the requirements issued by the European Union or by the United States of America, Canada, Japan or Australia are adopted. The November 2013 national procedure (§6.3 provision 24) restates the rule: the device must also satisfy the requirements of Lebanese standards where they exist.

Lithuania maintains a national 'technical condition inspection' regime for in use devices: a mandatory inspection of the device, including verification of all parameters and safety tests, carried out within the time limits and procedure set by device usage legal acts and the manufacturer; VASPVT issues the permits entitling persons to perform such inspections (Art. 75(2)(8)).

Under HSL Art. 59 2(4 1) (added 2024 06 21), failure to adopt a decision on issuing or refusing the permit entitling a person to perform medical device technical condition inspection within the time limit set in Art. 59 2(4) is not deemed to be issuance of the permit.

Because the MDR and IVDR apply directly in Malta and S.L. 458.59 has no standards annex or national standardisation schedule, the conformity presumption is the Union one: devices in conformity with the relevant harmonised standards, or the relevant parts of them, whose references have been published in the Official Journal of the European Union, are presumed to conform to the requirements of the Regulation covered by those standards. The same presumption applies to system or process requirements imposed on economic operators or sponsors, including those relating to quality management systems, risk management, post market surveillance, clinical investigations, clinical evaluation and post market clinical follow up.

Products, equipment, devices or apparatus intended for telecommunications or broadcasting that can be connected to a network or use the radioelectric spectrum must be homologated under applicable NOMs or Technical Provisions (LFTR Art. 289); the obligation is not limited to public networks. The IFT homologation lineamientos provide a Tipo A registry applicable to scientific, medical or industrial equipment, subject to non interference conditions.

Medicines, medical devices and other health supplies are governed by the Farmacopea de los Estados Unidos Mexicanos (LGS Art. 195, paragraph reformed DOF 10 05 2023), which the Secretaría keeps permanently updated; device registrations require laboratory tests verifying product specifications (RIS Art. 179 VII).

AMDM publishes the definitions that govern standards in the device field. A "standard" is a document established by consensus and approved by a recognised body, providing for common and repeated use rules, guidelines and characteristics for activities or their results, aimed at achieving an optimal degree of order in a given context; the application of a standard is voluntary. A "harmonised standard" means a European standard as defined in art. 2 of Legea nr. 20 din 04.03.2016 cu privire la standardizarea națională. An "international standard" is a standard adopted by an international standardisation organisation and made available to the public, and a "European standard" is one adopted by a European standardisation organisation and made available to the public.

For laboratory diagnostic devices, Order A/206 requires a manufacturer certified copy of the ISO 13485 quality management system certificate, quality assurance documents including stability data and, where necessary, accredited laboratory test results.

A device is deemed to meet essential requirements when it conforms to Montenegrin standards adopting the corresponding harmonised European or international standards, whose list is published in the Official Gazette of Montenegro. Article 22 includes the relevant national pharmacopoeia monographs and current European Pharmacopoeia monographs, particularly those concerning surgical sutures.

Article 3 of arrêté 2856 15 provides that the rules of good practice for the manufacture, transport, storage, distribution and performance evaluation of medical devices (required by article 11 of loi 84 12) are those set out in the Moroccan standard NM ISO 13485 in force.

Article 19 of loi 84 12 requires devices emitting ionising radiation to have satisfied, before their registration, the conditions laid down by the legislation and regulations on protection against ionising radiation. Article 4 of arrêté 2855 15 makes their registration subject to presentation of a document evidencing satisfaction of those conditions.

For a locally manufactured device the registration dossier must contain technical documentation comprising a checklist demonstrating the device's conformity to the essential requirements of quality, safety and performance, indicating those not applicable, together with the corresponding standards and the reference to the internal documents used. For an imported device the same documentation may be called for during the evaluation of the clinical data.

Medical devices are deemed safe if they are manufactured in accordance with the national standards published in the List of Standards for Medical Devices. The Director of the Agency publishes that List in the Official Gazette of the Republic of Macedonia, which makes the standards list an instrument of the Agency rather than a fixed annex to the Law.

Rule 68 provides that the standards for testing of medical devices shall be in accordance with the international standards; the rules do not name a mandatory local standard, and conformity evidence accepted elsewhere in the rules consists of ISO 13485, CE marking by NANDO notified CABs, WHO prequalification and free sale certificates.

DNDM has issued product specific rules: Resolución 066/2021 (Laboratorio Central de Referencia for IVDs), Resolución 037/2022 (waives diagnostic evaluation for self applied SARS CoV 2 antigen tests within registration), Resolución 694/2023 (classification of dressings with active ingredient), Resoluciones 004/2023 and 003/2024 (latex condom importation), Resolución 001/2021 (storage and distribution guidelines) and Resolución 001/2023 (good storage practices).

For an imported device, compliance with quality standards in production is evidenced either by a BPF/GMP document issued by the competent sanitary authority in the country of origin or by an ISO 13485, CE, UL, FDA, TUV or MDSAP certificate, or another equivalent certificate issued by a certifying body. For a national product, the same item is a BPF/GMP document issued by DINAVISA or an ISO 13485 or equivalent certificate.

Article 29 lets DINAVISA order at any time the review, inspection, sampling and ex officio analysis of any medical device to verify functionality, efficacy, quality and safety for user, patient and environment, and to verify health establishments and device trading companies under Art. 9 of Ley 4659/2012; the tests, studies, trials or analyses ordered are at the cost of the product holder, or of the importer or manufacturer for devices without registration or NSO.

An imported device application must include a quality control certificate for the finished product covering all tests guaranteeing functionality, quality and safety under the applicable norms, or a product conformity certificate issued by a Notified Body.

DINAVISA's application guide requires, for class III and IV devices, a technical summary of efficacy and safety supported by manufacturer documents such as the clinical evaluation, and states that the MERCOSUR Technical Regulation 'Requisitos Esenciales de Seguridad y Eficacia de los productos médicos' (Resolución GMC N° 72/98) and its updates must be taken into account.

For both national and imported products, Article 6 of Resolución DINAVISA 226/2024 requires medical devices that emit radiation to hold the Licencia de Protección contra las radiaciones for use and application in human medicine, or an equivalent document, issued by the competent Autoridad Reguladora Radiológica y Nuclear (ARRN) under Paraguayan rules.

Health units must ensure periodic verification of medical devices in use as required by law (Legea 95/2006 art. 933(1)(h)); Ordin 2219/2022 sets the devices subject to control and verification periodicity in its annex 1, requires a responsible person and register of devices in use (art. 20), and prohibits use of devices that fail the tests (art. 21(1)).

Second hand medical devices may be used only following performance evaluation by ANMDMR and its aviz, and must bear CE marking (Legea 95/2006 art. 931(1)).

For Class A non sterile, non active, non measuring devices submitted by notification, Rwanda FDA requires a valid manufacturer certificate of compliance with ISO 13485 or its equivalent, a Declaration of Conformity and the other notification documents. Instructions for use and a sample in commercial packaging are requested where applicable.

Rwanda FDA’s registration guideline requires a QMS audit certificate or proof of application for a QMS audit for Class C and D medical devices and IVDs. The QMS audit section permits equivalent QMS certification by another regulatory authority, including ISO 13485 certification.

A 'certificat de conformité' is a written attestation issued by a conformity assessment body recognised by the competent authority stating that the manufacturer correctly applies the essential requirements; a 'déclaration de conformité' is the manufacturer's own written attestation that it applied the conformity assessment elements for the device's class; an 'organisme d'évaluation de la conformité (OEC)' is a body other than a regulator charged with determining whether the relevant regulatory requirements or technical standards are met.

Devices on the homologation list may be placed on the market only after a conformity evaluation against the essential safety, quality and performance requirements, sanctioned by a marketing authorisation; the homologation dossier undergoes an administrative evaluation by ARP, a technical evaluation by an expert committee and validation by a national commission, whose creation, composition and functioning are fixed by ministerial order.

Article 26 provides that the essential requirements on quality, safety and performance of medical devices are defined in Annexe 1 of the decree, titled 'Les exigences essentielles relatives à la sécurité et à la performance des dispositifs médicaux', which opens with general requirements (A) on risk acceptability, state of the art design and intended performance, followed by design and manufacturing requirements (B) up to B14 clinical evaluation. No harmonised or recognised standards list is published; conformity is assessed against these essential requirements.

In market surveillance of medicines and other health products, ARP may found its decisions on the analytical results and regulatory decisions of other national regulatory authorities of at least WHO maturity level 3 or equivalent, or of control authorities with which it has a recognition agreement; test results from laboratories accredited and/or prequalified by WHO are also recognised.

Authorities may delegate device testing wholly or partly to qualified bodies. Delegates need testing capability for the items, premises, facilities and equipment, plus documented testing procedures and a quality assurance plan. The delegation contract must state the delegated items, schedule, the delegator's supervision and audit rights, confidentiality, termination and dispute mechanics. Test reports must record report numbers, delegate and delegator identity, sample description with photographs, receipt/testing dates, methods and results, the device's brand/model/serial or batch, manufacturer, licence number and shelf life, and the signatory's signature or seal.

Institutions seeking accreditation for medical device testing must run a dedicated laboratory with the necessary equipment, premises and quality system, staffed with a laboratory head, report signatories, technical head, quality head and testing personnel holding relevant degrees plus three years of testing experience (a master's degree offsets one year, a doctorate two). Applications attach proof of the conditions, capability evidence, the quality manual, testing SOPs, measurement uncertainty evaluations for quantitative items, method validation reports and the report format with signatories' signatures. The central authority reviews documents and conducts an on site assessment; deficiencies require an improvement report within 60 days for re evaluation.

The accreditation certificate is valid for three years; extension is applied for between 8 and 6 months before expiry, each extension capped at three years, with unchanged documents not re submitted. Address, method, scope or signatory changes must be filed within 30 90 days; a relocation requires a 15 day advance relocation plan. The authority conducts periodic and unannounced audits and can order proficiency testing; failing proficiency testing triggers a 15 day improvement plus retest. False data or refusal of oversight can suspend or revoke accreditation, with a one year re application ban after revocation.

For medical devices of animal origin (collagen, bone, …) the file must contain an attestation of conformity to the ISO 22442 standard and/or an attestation of conformity to Regulation (EU) 722/2012, drawn up by the manufacturer.

Item k (Biocompatibilité) of the avis technique dossier requires: (1) an attestation of conformity to ISO 10993 1 for all devices, drawn up by the manufacturer; (2) an attestation of conformity to ISO 10993 7 for products sterilised with ethylene oxide, drawn up by the manufacturer; and (3) an attestation of conformity to ISO 10993 11 for apyrogenic products, drawn up by the manufacturer.

The manufacturer's declaration of conformity required in every device file must state, among its minimum contents, the reference to the standards (ISO, EN) to which the device is declared conformant. Where a device is placed in the 'analyse' control track, the dated and signed lot analysis bulletin must include the tests performed, the acceptance intervals of the specifications and the normative reference associated with each test, together with a detailed description of the analytical methods; if end of shelf life specifications differ from release specifications they must also be supplied.

For sterile devices the file must contain a sterility attestation stating the lot numbers and expiry dates of each article, the normative reference of the sterilisation process, and the date and visa of the responsible person. The guide notes that the result of a sterility test stated on an analysis bulletin may be accepted.

The registration guideline defines Recognized Standards as national or international standards deemed to offer the presumption of conformity to specific essential principles of safety and performance; the guideline does not publish a list of recognised standards.

For appliances without certification to any of the quality system standards in Table 3, the application must contain the manufacturer's Declaration of Conformity to the IMDRF Essential Principles of Safety and Performance (or the checklist in Appendix II), summary information on pre clinical design verification and validation, product and manufacturer details, evidence of repeat sales in the country of manufacture, product samples where practicable and the submission checklist.

Imported drugs must be accompanied by the certificate of analysis issued in the country of manufacture and the certificate of conformity or test report for the specific batch or lot; on arrival NDA inspects the consignment to confirm compliance with approved specifications and that each batch has a certificate of analysis.

MHRA publishes designated standards lists in support of the Medical Devices Regulations 2002 (as amended), with a consolidated list (version 2, dated 17 January 2026) available for reference by businesses; conformity with a relevant designated standard supports compliance with the essential requirements.

Where the measuring and test means or test conditions required for device sample testing do not exist in Uzbekistan, the tests may be conducted at the foreign manufacturer's testing laboratory or at other foreign laboratories with the participation of the Centre's specialists.

statement: Where necessary, samples of a non in vitro medical device may be analysed by the National Drug Quality Control Laboratory (NDQCL) against the manufacturer's claimed specifications in accordance with available local standards or other quality specifications such as those prescribed by the International Organization for Standardization and any other internationally recognised standards. For IVDs, the Authority's NDQCL or an appropriate laboratory recognised by the Authority may test sample devices, with the number of samples determined and requested by the NDQCL, and the laboratory's test report forms part of the evaluation process. 'Recognised standards' are defined in the guidelines as national or international standards accepted to offer conformity to specific essential principles of safety and performance. The dossier requires two certificates of analysis for each device.

No condom may be approved unless it meets the standards in the Second Schedule or as specified by the Authority in guidelines. The Second Schedule fixes batch size/sample size/non complier tables (dimensions, package seal, air inflation, water pinhole) in Part I and, in Part II, performance requirements (burst volume and burst pressure before and after oven conditioning, freedom from holes, visible defects) verified by laboratory testing under ISO 2859 1 inspection level G 1 with AQL 1.5, plus dimensional and lubricant requirements at level S 2/S 3.

statement: Approval depends on the product meeting the standards in the Second Schedule to the relevant regulations, or standards the Authority specifies from time to time in guidelines, and the testing is performed by MCAZ's Medical Devices Laboratory. The laboratory is ISO 17025 accredited by SADCAS in condom testing methods, and quality conformity assessment is performed 'in accordance with international standards and WHO guidelines and specifications'. Condoms are tested for bursting volume and pressure, freedom from holes and visible defects, package seal integrity, dimensional testing (length, width and thickness) and total lubricant content; gloves are tested for dimensions, watertightness and tensile strength and elongation at break before and after accelerated ageing, with sampling in accordance with ISO 2589 1 and specified inspection levels and AQLs. Costs of testing are borne by the importer, manufacturer or wholesaler.