QMS, audit & inspection by country

Registration evidence includes the foreign CE or FDA certificate, with conformity routes for CE set by VKM 731 point 8 (e.g. Annex II full quality assurance for classes III and IIb, Annex VII self declaration for class I); AKBPM device inspectors inspect the manufacturer's quality assurance system and may order device tests, take samples and order proper labelling.

The dossier must include a document showing that all actors involved in manufacture and, where applicable, clinical trials of the finished product are authorized in their country for the declared activities, notably as regards compliance with good manufacturing practices (BPF), ISO standards, good laboratory practices (BPL) and good clinical practices (BPC); the renewal dossier must show these authorizations remain in force.

iso relation: local qms with iso evidence · local regime: BPF (Buenas Prácticas de Fabricación) per Disposición ANMAT 194/99 required for registration; BPF certificate and habilitación certificate must be presented together. · iso role: ISO 13485 is supporting evidence, not an automatic BPF waiver. · mdsap role: affiliate audit report and certificate use

Manufacture of medical devices in Armenia is carried out in accordance with International Organization for Standardization standard 13485 (ISO 13485). The manufacturer introduces and maintains a quality management system for medical devices and ensures its evaluation. For manufacturers of risk class 2a (sterile), 2b and 3 products, the Expert Organisation carries out professional observation at the manufacturing site once every three years in accordance with the established requirements; the costs connected with the professional observation are reimbursed by the manufacturer under a contract concluded between the parties in the procedure established by law.

iso relation: regulatory qms aligned with iso · local regime: TGA audits the manufacturer's QMS as part of Conformity Assessment against regulatory requirements and ISO 13485:2016, with on site or desktop assessments; surveillance audits continue after certificate issue · iso role: ISO 13485 certificates alone do not create ARTG inclusion; evidence of audits by comparable overseas regulators or MDSAP auditing organisations may support an abridged desktop assessment · mdsap role: rac member audit reuse

The Medizinproduktebetreiberverordnung (MPBV, BGBl. II Nr. 70/2007) imposes national operator duties on health facilities for erecting, operating, using and maintaining medical devices, including incoming inspection (Eingangsprüfung), user training (Einweisung), maintenance, recurring technical safety checks, metrological checks, a device file (Gerätedatei) and inventory records (Bestandsverzeichnis).

Active non implantable medical devices operated in health facilities must undergo recurring technical safety checks at intervals set by the manufacturer or, absent manufacturer specification, by a suitably qualified person as a rule every 6 to 36 months (6 to 24 months for Annex 1 devices); an overrun of up to six months is permitted; checks may only be performed by persons/bodies meeting Annex 3 requirements; the test protocol must be retained at least five years and devices that pass must be marked with the next due date.

The registration dossier must contain a copy of the manufacturer's quality management system certificate for the manufacture of the medical device, and the manufacturer's declaration of conformity of the device's manufacture with safety and effectiveness requirements stating the risk degree. Neither item is required for devices manufactured in Azerbaijan. The rules contain no provision for a regulator audit of the foreign manufacturing site as part of registration.

The unconditional documentation set for Bahraini registration requires a Quality Management System certificate to ISO 13485 for the physical manufacturer, whose address must match the relationship letter, together with verification evidence. Certifying bodies issuing quality assurance certificates must be recognised by the EU for CE certificates and by IAF for ISO certificates.

When registering importable drugs (including devices), DGDA may, if needed, inspect the manufacturing premises of the foreign manufacturer for GMP verification; all inspection costs are paid by the manufacturer at rates set by the Government.

For Classes B, C and D (medium to high risk), certification by a notified body with regard to the QMS is required, and for Class D also certification for the design of the device; manufacturers/importers then apply for registration with documents specified by DGDA, and DGDA issues registration based on those documents and any inspection.

Drug (including device) manufacturers and sellers must follow WHO Good Practices (GxP) guidelines in manufacture, quality control, distribution, supply and storage.

National registration is preceded by production inspection by RUP CEIZ, required when: the device is made on a first declared production site (except non sterile foreign class 1); the site was previously declared only for devices circulating in the USA/EU or for EAEU registered devices (except non sterile foreign class 1); class 1 (sterile), 2a, 2b or 3 devices are made on a site previously declared only for class 1; the site address changes; or a new site is added. The inspection is conducted under a separate contract by a commission of RUP CEIZ experts.

A QMS conformity certificate for the producer (and production site, where applicable) must be included in the registration dossier; the registration dossier must contain production inspection results confirming compliance with requirements set by the Ministry of Health.

Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effective manner and in a manner proportionate to the risk class and the type of device; the system covers design and manufacture through final inspection and is assessed by the notified body as part of conformity assessment (Annex IX Chapter I).

statement: Independently of the quality system certificate filed, the competent directorate may at any time require in situ verification of the plant or request information or reports from the regulatory authority of the country of origin on compliance with the quality system used. · article: Numeral 2.3.1, second paragraph

In carrying out inspection supervision in the field of medical devices, an Agency inspector has the right and the duty to supervise the manufacturer's quality assurance system and, where necessary, the premises of the supplier or other contracting party of the manufacturer; to order suitable testing and verification of a device to assess its conformity with the Act after it has been placed on the market or put into use; to take samples of a device and order a conformity assessment procedure; temporarily to prohibit the manufacture, testing and marketing of medical devices for failure to meet prescribed conditions or where public health is endangered; temporarily to prohibit marketing of a device marked contrary to the Act; to prohibit marketing of a device that does not meet the prescribed conditions; and temporarily to prohibit the operation of a legal person where the application of a quality system for the device is not insured.

For Class B, C and D medical devices BoMRA requires proof of a quality management system, such as an ISO 13485 certificate or equivalent, as a mandatory item of the registration dossier. The abridged pathway additionally conditions eligibility on a 'valid ISO 13485 certification or equivalent'.

CBPF (GMP certificate) certification is not available for class I and II health products; only class III/IV products are certifiable, so CBPF conditions class III/IV registrations.

Each manufacturer must establish and maintain a quality system under RDC 665/2022, which incorporates MERCOSUL GMC Resolution 20/2011 into Brazilian law and applies to manufacturers, distributors, warehousers and importers.

AITI may direct a person who operates equipment to cease operating it and may direct an importer to produce equipment for testing or inspection; the person must comply at his own expense and, at his own expense, send the equipment for certification or testing by any local or foreign body recognised by the Authority.

The only quality system control in the Medicines Act is that import, manufacturer's and wholesaler's licences for medicinal products 'shall only be issued after an inspection' (s. 15(1)), and the inspection power in s. 60(1) is limited to substances or articles appearing to be medicinal products, their containers, labels and leaflets, and plant used to manufacture medicinal products. No quality management system, ISO 13485, GMP certificate or audit requirement applies to a medical device manufacturer, importer or distributor.

For registration of Class I sterile and Class I measuring function devices (and pre use sterilisation systems/sets), BDA requires a valid manufacturer quality system certificate among the application documents; the document list also includes the declaration of conformity, a valid EC certificate where applicable, and label and IFU in Bulgarian.

The quality system limb of Cambodian device control that is readable at instrument level is the ASEAN one. Article 5(1) of the ASEAN Medical Device Directive requires a medical device that is required to be assessed by a Member State and is intended to be placed on that Member State's market to be assessed by the Regulatory Authority of that Member State, or by any appointed bodies recognised by that Member State, for conformity and compliance with at least the requirements laid down in the Directive, unless the device is exempted from registration under Article 6(2); Article 5(2) requires Member States to put in place an appropriate system for that conformity assessment. Within the ASEAN Common Submission Dossier Template, section 4.6 requires the applicant to summarise, reference or contain documentation on the manufacturing processes, including quality assurance measures, appropriate to the complexity and risk class of the device, and section 4.6.1 requires that where multiple facilities are involved in the manufacture of the device, the applicable information for each facility — given as quality assurance certificates issued by an accredited third party inspection body — must be submitted. The harmonised Declaration of Conformity elements likewise require the quality management system certificate to be identified by certification body, certificate number, issue date and expiry date, and the declaration to carry the date from which it is valid.

regulatory requirement: MDR s.32 requires a certificate to CAN/CSA ISO 13485 issued by a registrar recognized under s.32.1 · operative regime: Health Canada requires MDSAP: the transition announced December 2015 was completed in 2019 and all manufacturers holding Canadian medical device licences now participate; CMDCAS was replaced · plain iso substitute: No

For devices incorporated by Decreto Exento N°25/2026, ISP's verification of conformity is a documentary review per Título IV of D.S. N°825/1998 and the following technical norms: NCh ISO 16142 1 and NCh ISO 16142 2 (essential principles of safety and performance for DM and DMDIV), NCh ISO 13485 (quality management systems, regulatory purpose) and NCh ISO 14971 (application of risk management); product specific norms in the decree's table apply where corresponding.

The registration dossier must include the legal manufacturer's quality management system certificate for manufacturing — ISO 13485, ISO 9001 or another equivalent — consularized or apostilled.

The revised Medical Device GMP (医疗器械生产质量管理规范) takes effect 2026 11 01 and simultaneously repeals the 2014 GMP (CFDA Announcement No. 64 of 2014, in force since 2015 03 01). Until 2026 11 01 the 2014 GMP remains the manufacturing QMS standard.

During registration review, the drug regulatory department organizes a quality management system verification (registration QMS check) when it considers one necessary.

Establishments that manufacture, semi process, package or pack medical devices must comply with the device Good Manufacturing Practices (BPM) issued by the Health Ministry (Art. 8); while BPM implementation is pending, INVIMA issues a technical opinion on sanitary conditions, and per INVIMA's current FAQ national manufacturers need only the 'certificación de condiciones sanitarias'.

For dispositivos médicos considered equipos biomédicos, in post sale the manufacturer or importer must offer verification, maintenance and calibration services with the spare parts and tools needed to keep equipment within the safety ranges set by the manufacturer; responsibility for functioning is shared between the manufacturer (or its representative in Colombia for imports) and the owner/holder.

The registration dossier accepts a copy of the certification of the quality system used CCAA or BPM or its equivalent so foreign quality system certificates are accepted as equivalent; INVIMA may verify quality conditions when it considers pertinent.

The dossier must include a manufacturer GMP certificate (or its equivalent in the country of origin) issued by that country's health authority or authorized entity, covering all establishments involved in any lifecycle stage (design/development, production, storage/distribution, installation, technical support). However, Transitorio I of Decreto 43902 S suspends this requirement until a national EMB GMP regulation exists; Transitorio IV ordered the Ministry to issue that GMP regulation within 12 months of entry into force.

Pharmaceutical inspection in Côte d'Ivoire is exercised by sworn pharmacy inspectors of the AIRP, who are charged with carrying out operations of control, inspection, investigation, recording of offences and seizure. The AIRP's organisation decree also establishes a directorate responsible for inspection and market surveillance of the pharmaceutical sector, and a directorate responsible for processing applications for establishment licences and other authorisations.

The manufacturer must comply with and apply the good manufacturing practice standards for medical devices in force; must draw up the technical documentation required for conformity assessment, identification and use of the device in the official language of the member state's competent authority; must establish a declaration of conformity and affix the conformity marking once conformity with the applicable requirements has been demonstrated; and must keep the technical documentation and the declaration of conformity for the life cycle of the product concerned. The same obligations extend to any person who assembles, packages, processes, refurbishes and/or labels one or more prefabricated products, or assigns them a device destination, in order to place them on the market or put them into service under its own name.

Supervision of the implementing act is carried out by the Ministry of Health, and the Ministry's Pharmaceutical Inspection performs market surveillance of medical devices and in vitro diagnostic medical devices, of notified bodies, and of the conduct of clinical investigations and performance studies. If a pharmaceutical inspector orders testing of a device, the cost is borne by the person who placed that device on the market or into use. Legal and natural persons must enable the inspection and, on request, make available the necessary quantity of samples and provide the necessary data.

In the Proceder E registration route and in the inscription process, CECMED performs the regulatory audit of the manufacturer's quality management system against the requirements of the current ISO 13485 standard and the CECMED requirements for quality management systems for medical device manufacturing. E 129 25 applies the terms and definitions of ISO 13485:2016 and NC ISO 13485:2018 and bases inscription on systematic evaluation of QMS compliance.

CYMDA's role is to monitor the market, protect consumers and safeguard public health, and it does so by inspecting manufacturers, importers and distributors, checking their products and taking the appropriate action when non compliant products are found. The inspection is carried out by the competent authority itself; Cyprus has no separate device inspectorate.

Periodic safety technical checks (bezpečnostně technická kontrola, BTK) of devices in use are performed in the scope and frequency set by the manufacturer; if the manufacturer sets no frequency for an electrical device, the BTK must be performed at least every 2 years (at the latest in the calendar month in which the deadline expires). The BTK of an electrical device includes an electrical check per the manufacturer's procedure or, absent one, the relevant technical standard for medical electrical equipment.

The safety technical check of an active class IIa device, of class IIb and III devices, and of IVDs may be performed exclusively by a professional qualified as biomedical technician, biomedical engineer or orthotist prosthetist, or a person with specified education and practice; the provider must ensure this.

Notified bodies ('bemyndigede organer') in Denmark must notify the Danish Medicines Agency of all issued, changed, extended, suspended or withdrawn certificates and of refusals of certificate applications under the MDR/IVDR procedures; they must also inform notified bodies in other EU/EEA states of suspended/withdrawn certificates, refusals, and issued certificates on request. DKMA supervises notified bodies and may perform inspections during clinical investigations, including access to patient records at trial sites.

statement: Registration and renewal of a sanitary product require a current good manufacturing practices certificate, or a quality system certification corresponding to the product's classification, of the manufacturing/packaging laboratory — legalised or apostilled where imported. DIGEMAPS's Dirección de Vigilancia Sanitaria operates a dedicated GMP inspection service addressed to manufacturing laboratories of medicines and sanitary products in all their classifications, at RD$ 25,000 per inspection area, with a stated response time of 40 working days, on the legal basis of Ley 42 01, Decreto 246 06 and the Normas particulares para la habilitación de los establecimientos farmacéuticos (2012). · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: market oversight · localApplicationRequired: Yes · targetDecisionRetained: Yes

National device/IVD reagent manufacturers must hold a device BPM certificate or an ISO 13485 certificate issued by a conformity assessment body accredited/recognized by the SAE or designated by the MPCEI, and register that ISO 13485 certificate with ARCSA (application via Quipux, review with two 8 day cure rounds, 10 day payment window); ARCSA publishes the database of registered laboratories. Until ARCSA issues a device BPM norm, classes I IV national manufacturers rely on the accredited ISO 13485 certificate.

Every registration (all classes, all types) must include a current manufacturer quality system certificate for the manufacturing site(s): for imported products, ISO 13485 or a rigorously superior certificate; for national manufacturing, a device BPM certificate or an ISO 13485 certificate registered with ARCSA; ISO 9001 is accepted only for teats and feeding bottles (tetinas y biberones).

For the international certificate route, QMS evidence is an ISO 13485:2016 or EN ISO 13485:2016 certificate issued by an internationally accredited certification body covering the product category; an FDA CFG stating cGMP compliance replaces the ISO 13485 certificate. ISO 13485 alone qualifies a local factory for the without CE route but does not itself issue Egyptian registration; MDSAP reuse is not explicitly provided for.

Local factories must hold approvals from competent industrial authorities and meet CAMD technical requirements for manufacturing sites (site layout, ceiling height, water precautions, generator etc.); factories classified as Class Is, IIa, IIb and III are covered, while Class I non sterile factories are excluded except devices in pharmaceutical dosage form. No site modification is allowed before EDA request and actual inspection. EDA inspection committees may also travel abroad (Chairman Decree 157/2021).

State and administrative supervision over compliance with the requirements laid down in the Medical Devices Act, in legislation adopted under it, and in Regulations (EU) 2017/745 and (EU) 2017/746 is carried out by Ravimiamet; supervision over the requirements of Chapter 3 of the Act in the provision of health services is carried out by Terviseamet. For state supervision the law enforcement body may apply the special state supervision measures provided in §§ 30, 31, 32, 49 and 50 of the Law Enforcement Act, on the grounds and under the procedure set out there; the measure provided in § 50 of that Act may be applied in the presence of the person checked, its representative or its employee. Ravimiamet may involve experts in checking a device's conformity and order a conformity assessment service for a device or its parts under the regulation made under § 22(10) of the Act; the assessment service is formalised as an expert opinion describing the results of the analysis, tests and expertise. Ravimiamet pays the cost of the ordered assessment service and returns the device or compensates direct material damage where the device is found to be conformant, and where the device is not conformant the undertaking concerned reimburses Ravimiamet for the assessment service.

The Estonian act adds the national institutional layer to the Union conformity assessment route. Under § 14(2) of the Medical Devices Act the notified body, its activity, the grant of its operating licence, the suspension or revocation of that licence, and state supervision over it are subject to the Product Conformity Act, with the derogations arising from the Medical Devices Act and from Regulations (EU) 2017/745 and (EU) 2017/746. Under § 14¹(1) Ravimiamet performs the acts and issues the administrative acts of the competent authority and of the authority responsible for notified bodies provided for in the Medical Devices Act and in Regulations (EU) 2017/745 and (EU) 2017/746, unless those Regulations provide otherwise; under § 14¹(2) Ravimiamet may determine a product to be a medical device if the product meets the requirements laid down in Regulation (EU) 2017/745 or Regulation (EU) 2017/746.

The quality management system obligation that applies to a device placed on the Estonian market is the Union one. Article 10(9) MDR requires manufacturers of devices other than investigational devices to establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effective manner and in a manner proportionate to the risk class and the type of device, covering all parts and elements of the manufacturer's organisation dealing with the quality of processes, procedures and devices, and addressing at least a regulatory compliance strategy including management of modifications, identification of the applicable general safety and performance requirements, responsibility of the management, resource management including selection and control of suppliers and subcontractors, risk management under Annex I Section 3, and clinical evaluation including PMCF. Article 52 requires a manufacturer to undertake an assessment of conformity under Annexes IX to XI before placing a device on the market: class III devices under Annex IX, or Annex X coupled with Annex XI; class IIb devices under Chapters I and III of Annex IX including assessment of the technical documentation of at least one representative device per generic device group (and for class IIb implantables other than the listed exceptions, of every device), or Annex X coupled with Annex XI; class IIa devices under Chapters I and III of Annex IX with technical documentation assessment of at least one representative device per category, or the Annexes II and III documentation coupled with Section 10 or Section 18 of Annex XI; and class I devices by EU declaration of conformity after drawing up the Annex II and III technical documentation, with notified body involvement limited to sterility, measuring function or reusability where those apply.

The EFDA medical device GMP site inspection programme applies to medical devices to be registered with the Authority that are subject to GMP inspection, and it applies to both foreign and local manufacturers of such devices. Foreign facility inspection reports are distributed for review through the Authority's GMP quality assurance process, and the guideline is expressly the instrument governing both the local and the foreign inspection programme.

EFDA's conformity assessment of the manufacturer's QMS depends on the device class. Manufacturers of Class I devices and Class A IVDs must implement and maintain the basic elements of a QMS but may exclude design and development controls; the QMS of Class I and II devices and Class A and B IVDs is normally not subjected to a premarket on site audit, with the exception of sterility or measuring function assurance, though EFDA may audit those facilities if it deems it necessary. Manufacturers of Class III and IV devices and Class C and D IVDs must maintain an effective QMS including design and development controls and comply with EFDA's current medical device GMP; for those classes EFDA reviews relevant existing certification and/or regulatory audit reports and undertakes periodic on site audits of the manufacturer's facility, and may issue a GMP certificate listing the covered devices and its validity period on satisfactory findings.

For registration, the manufacturer must hold valid and genuine certificates confirming implementation of a good quality management system in the device's production process. EFDA states that one of the certificates to be considered is an ISO 13485 certificate where it is issued by another notified body or registrar, and CE full quality system certificates (QMS and Annex II.3 MDD) covering the scope of the products where issued by another notified body. For applicable high risk medical devices a copy of a valid certificate of compliance with medical device GMP must also be provided.

Manufacturers (other than of investigational devices) must establish, document, implement, maintain, keep up to date and continually improve a quality management system ensuring compliance with the MDR in the most effective manner and proportionate to risk class and device type; the QMS is assessed by the notified body under Annex IX Chapter I (Art. 10(9) MDR).

Notified bodies must randomly perform unannounced on site audits at the manufacturer's site and, where appropriate, its suppliers/subcontractors at least once every five years, which may be combined with or in addition to periodic surveillance assessment; during such audits the NB tests an adequate sample of devices or of the manufacturing process to verify conformity with the technical documentation (Annex IX Section 3.4 MDR).

Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effective manner and in a manner proportionate to the risk class and the type of device; the system covers design and manufacture through final inspection and is assessed by the notified body as part of conformity assessment (Annex IX Chapter I).

Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effective manner and in a manner proportionate to the risk class and the type of device; the system covers design and manufacture through final inspection and is assessed by the notified body as part of conformity assessment (Annex IX Chapter I).

The device clinical investigation technical regulation makes an inspection of the clinical investigation a ground on which the Agency revokes its consent to that investigation: the Agency revokes its consent to a clinical investigation if, on the basis of an inspection of the clinical investigation, it is established that there is a high risk to the health and/or life of the investigation subjects, or that ethical and legal aspects were not observed during the investigation, as a result of which the rights and safety of the clinical investigation subject would be breached. The investigation dossier must also contain a document confirming manufacture of the device to the relevant standard, which may be filed as an original, a copy, an electronic document or another publicly available form with the source of obtaining indicated, accompanied by information confirming the right to manufacture the devices used in the investigation. The Agency may also require the certificate applicant or holder and the institution to submit any additional documentation and/or information connected with the investigation.

Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effective manner and in a manner proportionate to the risk class and the type of device; the system covers design and manufacture through final inspection and is assessed by the notified body as part of conformity assessment (Annex IX Chapter I).

For an application from a new manufacturing site, FDA will inspect the facility or use other means to verify compliance with cGMP regulations/guidelines before registration; no product is registered unless the facility complies with cGMP.

For all imported condoms, a mandatory foreign inspection of the manufacturing facility is conducted by FDA to ascertain cGMP/QMS compliance; the inspection fee is set in the Fees and Charges L.I.

The manufacturer must demonstrate a functional quality management system (QMS), a system for post market surveillance, technical documentation, and a declaration of conformity, plus registration of the manufacturing facility and the devices.

EOF Board Decision 6209/2009 (ΦΕΚ Β' 199/06.02.2009) sets specifications of Good Manufacturing Practice rules for medical aids ('Προδιαγραφές Κανόνων Καλής Παραγωγής Ιατρικών Βοηθημάτων'); it is still listed by EOF as additional national legislation alongside the EU framework.

Every establishment in the device and IVD supply chain — manufacturing plants, droguerías and distributors among the twenty classes listed in AG 712 99 Art. 71 — must hold a sanitary licence and is subject to inspection by the DRCPFA, which must verify compliance with the Health Code, AG 712 99 and the technical procedures it approves. The same article extends inspection to supermarkets and shops selling over the counter pharmaceutical products.

Acceptable manufacturer QMS evidence includes: ISO 13485 (or identical national/regional adoption) from a certification body accredited by a GACI (previously IAF) member signatory; GB/T 42061 from a CNAS recognised body; NMPA Manufacturing Licence; MDSAP certificate; or KGMP, with conditional pairings to the corresponding marketing approvals.

The MDD may inspect originals or certified copies of records held by the LRP; the LRP must produce them within two weeks after receiving the notice.

Devices listed in Annex 13 of 4/2009. (III. 17.) EüM rendelet (25 device groups) must undergo periodic technical review (időszakos felülvizsgálat) at intervals of 1, 2 or 3 years depending on the group; the duty rests on the provider handing over the device and on the operator.

Periodic technical reviews may only be performed by organizations holding a valid NNGYK decision (authorization) issued under 4/2009. (III. 17.) EüM rendelet 27. § (4).

Lyfjastofnun may enter places where medical devices are located — a manufacturing site, a sales point whether wholesale or retail, or another place where devices are used. It may not enter a dwelling or comparable place for that purpose without the consent of the owner or occupier or a court order. In an inspection or investigation it may take the samples and carry out the examinations and tests it considers necessary, and it may make the necessary examinations at an operator's premises and prohibit continued use, sale and distribution and seize documents or devices where strong grounds exist to believe the Act or the Regulations have been breached.

The Fifth Schedule QMS (design, manufacture, packaging, labelling, testing, installation, servicing) applies to manufacturers; for import and Chapter IIIA registration a notarised ISO 13485 certificate is the market access evidence, while domestic manufacture remains subject to the Fifth Schedule, Notified Body audits and licensing authority inspection.

For Class A manufacture no site audit is required before grant; the registered Notified Body must audit within 120 days after grant. For Class B the Notified Body audit precedes grant: audit within 90 days of application, report to the SLA within 30 days of audit, SLA decision within 20 days of the report.

Production of health supplies must comply with Cara Pembuatan yang Baik (CPB), evidenced by a certificate issued under the applicable rules; the CPB for devices and PKRT is set by the Minister. Production facilities need full time competent responsible persons with CPB training certificates, and contract/licence manufacturing must likewise hold a CPB certificate for the product type produced.

Quality management certification bodies for medical equipment are vetted and published by the directorate; the imed.ir site maintains the list 'موسسات صدور گواهینامه سیستم مدیریت کیفیت (CB)' as a cooperating institution category.

Implementation of a quality management system evidenced by an ISO 13485 certificate is a licensing requirement for device manufacturing.

Iraq's standard bidding document for medical appliances gives the Purchaser or its representative the right to inspect and/or to test the medical appliances to confirm their conformity to the Contract specifications. The Special Conditions of Contract and the Technical Specifications must state what inspections and tests the Purchaser requires and where they are to be conducted, and the Purchaser must notify the Supplier in writing, in a timely manner, of the identity of any representatives retained for those purposes. GCC Clause 9.2 makes the article subject to what is specified in the SCC.

HPRA assesses notified bodies and inspects manufacturers, authorised representatives, distributors, importers, manufacturing facilities, suppliers to manufacturers and third country sites; inspection fees are EUR 1,995 per day or EUR 285 per hour per team member (codes 471/472), with travel time and expenses chargeable in defined cases; fees and expenses may be waived in exceptional circumstances.

ISO 13485 certificates are required for every manufacturer in the product's supply chain; alternatively, valid GMP certificates may be attached. ISO 5001 certificates are required for other participants in the supply chain (e.g. subcontractors/suppliers). The official Q&A clarifies ISO 13485 is submitted for the manufacturer and/or the manufacturing sites of the device.

Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effective manner and in a manner proportionate to the risk class and the type of device; the system covers design and manufacture through final inspection and is assessed by the notified body as part of conformity assessment (Annex IX Chapter I).

For designated products, the manufacturer must undergo a document based or on site QMS conformity survey (書面/実地調査) by MHLW when seeking approval and again every Cabinet Order period (not less than 3 years; set at 5 years — Order Arts. 37 21 and 39); successful survey yields the 基準適合証 (conformity certificate).

Japan QMS is set by MHLW Ordinance No. 169 of 2004 (医療機器及び体外診断用医薬品の製造管理及び品質管理の基準), the standards referenced in Art. 23 2 5(2)(iv) (also applied to foreign special approvals via Art. 23 2 17(5)); conformity is verified by MHLW/PMDA or RCAB surveys — a plain ISO 13485 certificate is not a substitute, while MDSAP results can streamline the survey (from 2022 04 01).

JFDA inspects local factories to verify application of good manufacturing practice principles and follows up on them thereafter.

The Inspection Section of the Medical Devices and Supplies Directorate administers: initial and renewed manufacturing site accreditation for medical supplies, initial and renewed cGMP certificates, initial and renewed ML certificates, and certification of true copies of cGMP/ML certificates.

The manufacturer must implement and maintain a device quality management system per EAEU Council Decision № 106 (10.11.2017); during registration the reference state may decide on production inspection, whose report is included in the dossier and extends the expertise timeline.

Before submitting an application for marketing authorization of medical devices or IVDs, the applicant must first apply for GMP inspection, per the PPB GMP inspection and compliance procedure.

Applicants must provide proof of a Quality Management System, e.g. an ISO 13485 certificate, conformity to US FDA Quality System Regulations (certificate of free sale), Japan MHLW Ordinance 169, CE certificate from EU/UK/Ireland, or an attestation stating adequate QMS; copies of ISO 13485 certificates of new key subcontractors must also be provided.

statement: Manufacturers of devices other than investigational devices must establish, document, implement, maintain, keep up to date and continually improve a quality management system ensuring compliance with Regulation (EU) 2017/745 in a manner proportionate to the risk class and device type. That system must be an integral part of the manufacturer's organisation for all processes, procedures and devices affecting quality. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: Yes

Quality system evidence for registration is documentary: a certificate of conformity of the manufacturer's quality management system to ISO 13485, required for products whose countries of origin are other than the European Union, the USA, Canada, Australia and Japan, and accepted alongside certified conformity for reference origin products. The procedure provides no manufacturing site audit or inspection of the device manufacturer as part of registration; the unit's check is the coherence and authenticity of the documents supplied.

Hospitals must operate an internal reporting system for serious incidents within an established quality management system and designate a suitable qualified vigilance contact person with medical or technical training who performs the reporting duty towards the Amt für Gesundheit; the person's details are reported to the authority. EWR IvDV Art. 16(2) (3) mirrors this for IVDs.

Swissmedic conducts inspections in Liechtenstein at the request of the Amt für Gesundheit (e.g. maintenance, reprocessing and vigilance in hospitals; review of tissue/cell establishments), with legal responsibility lying with the Principality of Liechtenstein; the Amt für Gesundheit issues licences on the basis of Swissmedic review.

Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effective manner and in a manner proportionate to the risk class and the type of device; the system covers design and manufacture through final inspection and is assessed by the notified body as part of conformity assessment (Annex IX Chapter I).

Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effective manner and in a manner proportionate to the risk class and the type of device; the system covers design and manufacture through final inspection and is assessed by the notified body as part of conformity assessment (Annex IX Chapter I).

During registration ISAF may inspect the applicant's R&D and manufacturing sites and related documents to verify authenticity, consistency, manufacturing conditions and data reliability; applicants must be given at least 10 working days' notice of an inspection, and the date can be changed on reasoned request.

For registration, updated ISO 13485 certificates are required from the legal manufacturer, or other acceptable QMS evidence: MDSAP, US FDA Quality System Regulation, Japan MHLW Ordinance 169, or ISO 9001 (only for a Class A empty gas cylinder).

The Third Schedule prescribes class graded CAB scrutiny of the manufacturer QMS: Class A devices CAB verification limited to sterility maintenance and/or metrology compliance; Class B full QMS with CAB review and field audit where deemed necessary; Class C and D full QMS with CAB review and field audit; the manufacturer, AR for a foreign manufacturer, importer and distributor must each operate a QMS appropriate to their role.

MDA was recognised as an MDSAP Affiliate Member effective 16 September 2025 and accepts MDSAP audit reports and certificates as QMS evidence: local manufacturers for establishment licence applications (audit performed by an MDA registered CAB with an MDA registered MDSAP qualified auditor) and foreign manufacturers for device registration (reports issued by any MDSAP recognised Auditing Organisation).

The competent authority monitors and reviews operations conducted within premises to ensure the regulations are complied with, and for that purpose it — or any person authorised by it — has the right at all reasonable times, and where necessary with the assistance of the Executive Police, to enter and inspect any premises. Operators making devices available on the Maltese market must be registered with the Malta Medicines Authority, must have at least one registered Medical Device Registered Person with the requisite knowledge and experience in distribution and post marketing activities, and must operate under Good Distribution Practice conditions with an effective quality management system covering documentation, personnel training, complaints handling, returns and recall procedures.

local regime: NOM 241 SSA1 2025 (Buenas prácticas de fabricación de dispositivos médicos) is the mandatory GMP standard for all establishments manufacturing devices and for warehouses of acondicionamiento, depósito and distribution commercializing or supplying devices in Mexico; it entered into force 30 11 2025 and is partially equivalent to ISO 13485:2016. · iso relation: ISO 13485 is supporting evidence; the NOM is mandatory and partially aligned with ISO 13485:2016. · mdsap role: GMP certificates from MDSAP full members are recognized as reference authority evidence (Lineamientos Art. 24); the first prórroga of foreign made device registrations requires a GMP certificate from a recognized national regulatory agency (RIS Art. 190 Bis 4 II).

Among the basic attributions of AMDM's Direcția Dispozitive Medicale is that it evaluates and/or audits, on request, the natural or legal persons that apply for the registration of medical devices, in addition to coordinating device regulations and normative acts and tracking that revisions respect European norms and international standards.

The state administrative body responsible for medicines and medical devices has medicines and medical devices state inspectors whose duty is to carry out professional inspection (мэргэжлийн хяналт шалгалт) of the quality and safety of devices and of compliance with the legislation; the head of that body is the chief state inspector. The inspectors exercise the rights and duties of Article 10 of the Law on State Inspection and enjoy the guarantees of Article 11 of that law, and in addition may carry out an inspection without a warrant on the decision of a competent official where a situation has arisen that directly or indirectly causes, or is capable of causing, serious danger or harm to human life, health or the environment. They enforce the device legislation and standards and may inspect device imports and exports jointly with the customs authority.

The QMS evidence required to enter medical equipment into the medical device list is a copy of the manufacturer's medical device quality management system certificate (ISO 13485) certified by a competent authority and countersigned by the manufacturer; an application to renew an IVD registration must also include a copy of the manufacturer's ISO 13485 certificate.

In carrying out official controls the health inspector is empowered and obliged to review the general and individual acts, records, contracts, technical documentation and other documentation relating to the production, trade, labelling, declaration of conformity, testing and quality control of medical devices, as well as the documentation relating to the application of good manufacturing practice, good laboratory practice and good distribution practice; and to carry out a direct inspection of the application of good manufacturing practice and good distribution practice, as well as of the standard and operating procedures in those fields. The same article also empowers the inspector to inspect employees' identity documents, hear and take statements from responsible and interested persons, inspect business premises, facilities, installations, devices and equipment, inspect medical devices, their labelling, conformity mark, instructions for use and expiry dates, take copies of documents, take samples for quality verification, and photograph or record data for the purpose of gathering evidence.

A manufacturer outside the European Union applying to register a medical device must file, in addition to the standard dossier, a free sale certificate or a certificate issued by a body authorised for ISO 13485. The ISO 13485 certificate is thus the quality system evidence the Montenegrin registration route accepts from a non EU manufacturer.

A manufacturer must manufacture medical devices in accordance with the essential requirements and the decision issued by the Agency, and that manufacture is carried out under an established quality assurance system for the manufacture of medical devices, which the manufacturer proves by a certificate issued by an authorised body. A manufacturer that does not have that quality assurance system established must establish it in accordance with the Law.

Inspection is carried out on the order of the Minister of Health by at least two inspectors, at least one of whom must be a pharmacist inspector. Inspectors take an oath before the court of first instance and are bound by professional secrecy; they carry a professional card issued by the Minister. They draw up a report after each inspection, or a procès verbal of findings where an offence is punishable by law, and the report is transmitted to the Minister within seven days; a copy goes to the legal representative of the establishment concerned.

A copy of the ISO 13485 certificate is required in import recommendation applications for all classes (A, B, C/D).

A manufacturing licence or GMP certificate copy is accepted as manufacturing site evidence (Class A); for Class B, C and D an EC certificate is additionally accepted (manufacturing licence/GMP/EC certificate).

Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effective manner and in a manner proportionate to the risk class and the type of device; the system covers design and manufacture through final inspection and is assessed by the notified body as part of conformity assessment (Annex IX Chapter I).

statement: Medical devices are within the reach of New Zealand's statutory inspection machinery. Part 5 of the Medicines Act 1981 (Enforcement) gives an officer, at any reasonable time, power to enter and inspect premises or vehicles where an 'article to which this section applies' is manufactured, packed, stored or kept for sale, to examine any process of manufacture or packing and the means employed for testing materials, and to examine and copy the records relating to that manufacture, packing, storage or keeping for sale. Section 63(1) defines that expression to include any medical device, and also any equipment used or intended to be used in connection with the manufacture, packing or labelling of a medicine, medical device or cosmetic, and any package, container, advertising material or labelling material used in that connection. · powerHolder: An officer appointed under the Medicines Act 1981 (and any person assisting under the officer's direct supervision) · instrument: Medicines Act 1981 (1981 No 118) · scope: medical devices, medicines, cosmetics, and the equipment, packaging and labelling material used with them

For Class A devices the manufacturer may establish either a full QMS or a QMS without design and development controls; regulatory oversight increases from Class A to D as evidence and conformity assessment requirements become more demanding.

Premises for the manufacture of devices, IVDs and related products are inspected in accordance with the applicable regulations, the NAFDAC GMP guidelines, the current ISO 13485:2016 and other applicable international standards; GMP inspection is risk based, considering product/process risk, compliance history, device usage risk and recall actions.

The device registration dossier must contain a certificate for the EN ISO 13485 quality management system, in both documentation routes: for a device holding an EC certificate, and for a device without one. The certificate is required from a manufacturer seated in the European Union and from a manufacturer seated outside it, in the latter case together with the name of the authorised representative in the EU.

The Law gives MALMED's pharmaceutical inspectors a set of powers over medical devices: to inspect the manufacturer's quality control system, to order an assessment of conformity by an authorised body, to take samples and have them tested, to ban or temporarily ban the manufacture, testing or placing on the market of a device, to temporarily ban the work of a legal entity, to seize devices found with an unregistered manufacturer, to ban advertising, to order the destruction of a device, and to ban a clinical investigation.

DNV Product Assurance AS has been designated by the Norwegian Medical Products Agency as a notified body under the MDR and, as the first Norwegian notified body for IVDs, under the IVDR.

Direktoratet for medisinske produkter designates and supervises notified bodies in Norway (per MDR Article 35 and IVDR Article 31, read with the Act on technical control bodies).

Manufacturer registration requires the quality management system used and its certificates (e.g. ISO 13485) with certificate number and expiry date, plus attachments: QMS certificate, recent audit report, manufacturing/production process, manufacturer layout, commerce agency certificate and agreement with sub contract manufacturers (sub sites need the same).

Under rule 5(1), in processing an establishment licence application the MDB may inspect the premises of the establishment as it considers proper and necessary to verify information, particulars, documents and other requirements, and may constitute a panel of experts which may include inspectors or auditors; a satisfactory inspection report is a condition of licensing.

DNDM is authorized to issue Certificados de Buenas Prácticas de Fabricación, de Almacenamiento and de Distribución and to regulate their issuance; Resolución 852 de 30 Oct 2019 approved the manual for the Licencia de Operación procedure, and Resolución 001 de 10 Jan 2023 sets good storage practice rules.

The BPFyC and BPAyD verification inspections of device establishments are carried out by DINAVISA officials, who may enter the establishment even against the owner's refusal; refusal is treated as a serious infraction under Ley N° 1119/97 and Ley N° 6788/2021.

In lieu of a Peruvian BPM certificate from DIGEMID, applicants may submit a document evidencing compliance with quality norms specific to the device type by risk level, e.g. EC Certificate, current ISO 13485, FDA or others issued by the competent authority of the country of origin; manufacturers holding a valid DIGEMID BPM need only cite its certificate number in the sworn application.

Licensed device establishments are subject to FDA inspection: retailers face routine or spot check inspections verifying storage/distribution SOPs, qualified person credentials and product authorizations; failure to comply with licensing conditions is ground for LTO disapproval under AO 2020 0017 and AO 2014 029 (FDA FAQ).

For imported medical devices, applications require one copy of a government issued certificate attesting to the status of the manufacturer regarding competence and reliability of personnel and facilities, a Quality Systems Certificate of approval, or a compliance certificate for ISO 13485; the certificate must be valid, indicate the product applied for in its scope, and be accompanied by a notarized declaration; multi site/toll manufacturers must identify the product source.

Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effective manner and in a manner proportionate to the risk class and the type of device; the system covers design and manufacture through final inspection and is assessed by the notified body as part of conformity assessment (Annex IX Chapter I).

INFARMED supervises and inspects compliance with DL 29/2024, MDR and Implementing Regulation (EU) 2020/1207 across all establishments, institutions, units and sites in Portugal where device lifecycle activities are or may be carried out (design, manufacture, sterilisation, import/export, distribution, sale, use, installation, maintenance, consignment, loan, etc.).

Activities not liable to affect device conformity — sterilisation, maintenance, calibration, technical assistance or other services performed per manufacturer instructions — may only be carried out by entities with an implemented and maintained QMS, notably per EN ISO 13485.

Entities making devices available under loan or consignment must have an implemented QMS, notably per EN ISO 13485, proportionate to device risk class and type, plus qualified staff and a written contract with the user.

Healthcare investors may request the MoPH Health Facilities Licensing and Accreditation Department to conduct an assessment of the safety of medical equipment and devices, by downloading and filling an application form submitted to MoPH; no fee is charged.

MoPH conducts a technical evaluation for the safe use of medical equipment within a healthcare facility (new facilities or existing facilities adding equipment): per device it requires the FDA/CE certificate or equivalent approval, a certified copy of the certificate of origin, and a catalog or technical brochure; the facility must be licensed; fee is based on the type of healthcare facility; published delivery time 6 days and 1 working hour.

Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effective manner and in a manner proportionate to the risk class and the type of device; the system covers design and manufacture through final inspection and is assessed by the notified body as part of conformity assessment (Annex IX Chapter I).

The national dossier must include copies of QMS certificates to interstate standard GOST ISO 13485 2017 or international standard ISO 13485:2016 plus copies of reports of earlier inspections; alternatively, QMS documents issued by an inspecting organization of an EAEU member state (other than Russia) are accepted.

The QMS audit is part of the medical device registration process. All Class C and Class D devices must apply and pay the relevant QMS audit fees, and the Authority must inspect the manufacturing facility or use other means to verify QMS compliance before the device is registered, unless the device is under the abridged assessment procedure, in which case QMS compliance of the manufacturing site is confirmed through desk review. The Authority reserves the right to conduct a QMS audit for other classes where regulatory review or technical assessment indicates the necessity, and may conduct an on site inspection of an abridged assessment device if deemed necessary. Registration applications for Class C and Class D must include a Rwanda FDA QMS audit certificate or proof of a QMS audit application; for notification, a valid ISO 13485 certificate or equivalent is required. Under the fee regulations the registration fee for an imported device includes a GMP inspection covering up to five production lines at one site.

Manufacturers, importers, distributors and ARs must obtain a QMS certificate to Saudi Standard SFDA.MD/GSO ISO 13485:2017 (or latest published version) from SFDA designated Conformity Assessment Bodies (CAB). SFDA inspects the manufacturer's QMS at the pre marketing stage, and the SFDA or recognized CAB inspection report is one of the documents required for the Marketing Authorization Certificate.

Manufacturers must establish, document and maintain an effective QMS according to ISO 13485:2016 (or any identical adopted standard for the same issue/version) as a prerequisite for MDMA.

Compliance with the good practices in force is made an express statutory duty of medical device manufacturers and distributors: 'Art. 41. Les fabricants et les distributeurs sont tenus au respect des bonnes pratiques en vigueur.' For manufacturers this is particularised by the fifth indent of art. 34, which requires a newly established device manufacturing establishment to 'se conformer et appliquer les normes de bonnes pratiques de fabrication des dispositifs médicaux en vigueur' (comply with and apply the good manufacturing practice standards for medical devices in force). Official control is two layered: 'Art. 42. Le marché des dispositifs médicaux est assujetti à une surveillance par le Ministère en charge de la Santé.' (the medical device market is subject to surveillance by the Ministry of Health), and the post marketing surveillance system of art. 43 expressly includes 'le contrôle de qualité' (quality control) and 'l'inspection des différents acteurs de la chaîne d'approvisionnement' (inspection of the various actors in the supply chain) alongside import/export control, after sales service, promotion and advertising control, the fight against substandard and falsified devices and illicit sale, and matériovigilance. A separate conformity certificate concept exists in the definitions: a 'certificat de conformité' is a written attestation issued by a conformity assessment body recognised by the competent authority stating that the device manufacturer correctly applies the essential requirements.

Quality assurance of each batch of a medical device is performed in accordance with SRPS EN ISO 13485; a manufacturer without a certified quality management system per SRPS EN ISO 13485 performs quality assurance in accordance with the production bylaw itself. Contract manufacturing and contracted quality control agreements must be in writing and per SRPS EN ISO 13485.

The manufacturer must keep the technical documentation and the declaration of conformity after placing the device on the market for at least five years, and for implantable devices at least 15 years; it must also employ full time a qualified person responsible for quality and vigilance, and hold a damage insurance policy covering use of the device.

Manufacturers must maintain a QMS conforming to ISO 13485; Class B/C/D manufacturers need ISO 13485 certification by SAC accredited certification bodies, and MDSAP certification is accepted as an alternative. Class A manufacturers may submit a declaration of conformity in lieu of certification. Importers and wholesalers may adopt ISO 13485 or GDPMDS (SS 620).

Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effective manner and in a manner proportionate to the risk class and the type of device; the system covers design and manufacture through final inspection and is assessed by the notified body as part of conformity assessment (Annex IX Chapter I).

Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effective manner and in a manner proportionate to the risk class and the type of device; the system covers design and manufacture through final inspection and is assessed by the notified body as part of conformity assessment (Annex IX Chapter I).

Applicants must submit an ISO 13485 accreditation certificate or confirmation letter issued by a conformity assessment body recognised by SAHPRA; the requirement applies to manufacturers and distributors and is being phased in (Phase 3 in effect, voluntary confirmations to mdqueries@sahpra.org.za), with evidence required on licence renewal; wholesalers are not required to submit ISO 13485 certification, and the requirement applies even to establishments exempted from licensing.

Manufacturing licence applicants/manufacturers and import business applicants/importers must obtain KGMP conformity certification (적합성인정). The certificate is valid 3 years from issuance; changes such as manufacturing site (including overseas site) relocation require change conformity certification, and the certificate must be renewed before expiry.

iso relation: national qms aligned with iso additions · local regime: KGMP: national conformity certification (적합성인정) under Article 28 of the Act with facility/QMS standards in Enforcement Rule Annex 2; ISO 13485 aligned but retained as national conformity. · iso role: Plain ISO 13485 does not replace KGMP conformity certification. · mdsap role: affiliate audit report and certificate use · mdsap detail: MFDS guideline (2024) governs reuse of MDSAP audit results in GMP reviews.

To obtain the AEMPS operating licence, establishments must have a quality management system able to guarantee product quality, adequate installations/equipment/personnel, and a responsible technical person (titulación universitaria or ciclo formativo de grado superior) under contract with specified working hours; documentation per product must be kept available to authorities for at least ten years (fifteen years for implantables).

NMRA waived the GMP inspection requirement for local manufacturing sites of listed and Class 1 medical devices: manufacturers submit a Site Master File to the Manufacturing Regulatory Division (Thursdays) and receive a GMP Waiver Document to attach to product registration in place of GMP approval. A two year blanket GMP approval (10 May 2025 – 9 May 2027) allows manufacturers to obtain ISO 9001; after 9 May 2027 NMRA will only accept ISO 9001 in lieu of GMP inspection for these categories.

An ISO quality management system certificate is a common technical requirement: listed devices — ISO 13485:2016/2021 or ISO 9001:2015 (foreign sites); low risk listed devices locally — ISO 9001:2015 accredited by SLAB or equivalent competent body; Class I low risk and Class A IVD devices — ISO 13485:2016/2021 (local sites: SLAB accredited or equivalent); all other medical devices — ISO 13485:2016/2021.

Importers/distributors performing re labelling/translation or repackaging under MDR/IVDR Art. 16.2 16.4 must have their quality management system verified by a notified body, and must upload the certificate (notified body number and name, certificate number, validity dates, PDF) when registering the activity with Läkemedelsverket; certificates can be newly registered but not changed or deregistered.

Manufacturers' further obligations, in particular the requirements for the quality management system and the risk management system, follow Art. 10 EU MDR as incorporated by reference into the MedDO (for IVDs, Art. 10 EU IVDR via the IvDO).

Manufacturers performing sterilisation must be equipped with sterilisation equipment and sterility testing equipment (the latter excused where sterility testing is not performed). Packaging and labelling areas need measuring instruments, filling, packaging, sealing, label printing and batch number printing equipment as the work requires. Facilities and equipment used to demonstrate product conformity must be controlled, calibrated, verified, confirmed and maintained, with records kept under the QMS Regulations.

The central authority may conduct unannounced inspections of distributor premises at any time without prior notice. Municipal/county authorities may be invited to join. Inspectors must show identification, state the inspection purpose, and may take evidence preservation measures against breaches of the Act or the GDP Regulations.

Manufacturers producing only announced low risk device items (listed in the annex to the QMS Regulations) are subject to a reduced QMS: they must keep per type/series device files and implement record control, complaint handling, and corrective and preventive measures, and only the listed articles (11 13, 47, 55, 63, 64, 69, 76, 77) apply; the remaining chapters do not.

Beyond the initial and periodic QMS inspections, the central authority may take product samples when conducting inspections. Sampling is free of charge and random; the manufacturer may not designate the samples, and quantities are limited to what testing requires.

Manufacturers must establish a QMS under the QMS Regulations, pass central authority inspection and obtain a manufacturing permit (製造許可) before manufacturing; foreign manufacturing sites are subject to the same rules mutatis mutandis and the central authority may conduct on site inspections abroad. The QMS Regulations are written with reference to ISO 13485 (Medical devices Quality management systems Requirements for regulatory purposes).

The QMS manufacturing permit is valid for three years. Extension must be applied for between 12 and 6 months before expiry, each extension being at most three years; if the applicant files in time but the authority has not decided before expiry (not attributable to the applicant), the permit remains effective until the decision date. Failed applicants may request re evaluation once within two months of the adverse notice.

Manufacturers must establish the quality management system in writing and maintain its effectiveness, determining the processes needed, monitoring them on a risk assessment basis, and defining their sequence and interactions, with criteria, methods, resources, monitoring/measurement and records ensuring conformity with the Act and the QMS Regulations. QMS process changes require an impact assessment on the system and the device before adoption.

A valid certificate of compliance with ISO 13485 standards (or equivalent) from the manufacturer, issued by a recognized Conformity Assessment Body (CAB), is required; manufacturers in Tanzania must be registered by TMDA prior to notifying their products.

Import or sale of medical devices must comply with the Ministerial Notification on quality systems for import or sale of medical devices B.E. 2566 (2023).

The conformity certificate accepted in a Tunisian device dossier depends on risk class. For class I devices (I, Is, Im), the file must carry a valid certificate of conformity to the ISO 13485 standard issued by a certification body. For every other device, it must carry a CE certificate of conformity matching the risk class of the device and the requirements of Regulation (EU) 2017/745. Only CE certificates issued by notified bodies notified to the European Commission (those listed on the NANDO site) are accepted. Where no valid MDR CE certificate exists, the file carries instead a copy of the written agreement under Annex VII section 4.3 second paragraph of Regulation (EU) 2017/745 signed between the manufacturer and the notified body, or a letter from the notified body confirming the status of a formal application, the written agreement and appropriate surveillance under Regulation (EU) 2023/607.

Within its quality control mission ANMPS carries out audits of the manufacturing sites of medicines and of medical devices. These inspections verify that installations and manufacturing processes conform to good manufacturing practice (BPF). The audits cover an evaluation of the infrastructures, the production methods and the quality control systems; at the end of each inspection a report is drawn up together with recommendations or corrective measures where necessary.

The Kurum designates Turkish notified bodies and withdraws the designation if the notified body ceases its activities; notified body identification data follow the EU NANDO references (Madde 47).

NDA recognises the medical devices quality management systems requirements of the ISO 13485:2016 standard as the basis for the regulated medical devices current good manufacturing practices (cGMP), but compliance with ISO 13485:2016 does not replace the Authority's regulatory requirement of cGMP. INS/GDL/047 Rev 0, effective 6 September 2023, sets out the cGMP requirements for design and development, manufacture, storage, distribution, installation or servicing of surgical instruments and appliances, and forms the basis of GMP inspection by NDA as one of the requirements for registration in Uganda. Its scope is expressly extraterritorial: the guidelines are to be used for GMP inspections of all local and foreign manufacturers of surgical instruments and appliances whose products are registered or subjected to registration in Uganda, and they establish requirements applicable to manufacture including in vitro diagnostics. DAR/GDL/028 Table 3 separately lists the quality system standards NDA accepts from the five IMDRF founding member countries, and s. 4.3.1 provides that a pre registration GMP inspection or quality system audit may be conducted as part of evaluation of a surgical instrument or appliance.

For quality system and product certificates (Annex 3), the designated body must periodically conduct checks and assessments to verify the approved quality system is applied (with a report to the manufacturer) and may conduct additional unannounced on site checks.

An applicant for marketing approval must implement a quality assurance and product traceability system, a pharmacovigilance system and post marketing follow up.

Registration of a medical device manufacturing site with EDE requires a valid legalized ISO 13485 certificate issued by the competent authority of the country of origin.

Where third party conformity assessment is required for UKCA marking, a UK approved body is needed; approved bodies must be located in the UK, issue the certificates that permit UKCA marking and market placement, and their identification number must be placed below the UKCA mark. UK approved bodies are not able to conduct conformity assessments in relation to the CE marking.

FDA may accept MDSAP audit reports as a substitute for routine Agency inspections of medical device manufacturers; firms with activities under the Electronic Product Radiation Control (EPRC) provisions of the FD&C Act remain subject to FDA inspection for those EPRC activities.

The dossier is evaluated documentarily and includes copies of quality certificates held by the company only 'if applicable'; recycled equipment must have a management system with process traceability. Registered companies must exhibit, on MSP inspection: the product registration certificate, a complete copy of the registration dossier, maintenance activity records (for equipment maintainers), a copy of the registration of products commercialised with supplier/acquirer documentation (distributors), and the applicable quality certificate.

MoH order (adopted 14.04.2026, registered 25.05.2026 No. 3838, in force 27.08.2026) sets the inspection procedure: document analysis within 15 working days, inspection program within 10 working days of the on site decision, and inspection report (compliance or non compliance) within 20 working days of completion. It does not apply to recognition route devices, WHO prequalified IVDs, or devices with a valid national ISO 13485 standard certificate whose production conditions were inspected during manufacture.

At registration the manufacturer's production quality system is inspected for conformity with the Uzbek national standard harmonized with ISO 13485; the dossier must include a copy of the current manufacturer's ISO 13485 QMS certificate issued by a valid accredited body, submitted before registration, and the inspection may run in parallel with registration. Exempt: recognition route devices, WHO prequalified IVDs registered in cooperation with WHO, and devices holding a current national ISO 13485 standard certificate.

Domestic manufacturing establishments must make a declaration of adequate production conditions (công bố đủ điều kiện sản xuất) using form Mẫu 01, with updates to the declared dossier notified on form Mẫu 12.

statement: An applicant must facilitate site audits of its manufacturing site to demonstrate compliance with ISO 13485, and the GMP inspection fees in the Medicines and Allied Substances (Fees) Regulations apply to a site audit. In deciding whether to conduct a site audit the Authority may take into account previous satisfactory site audit outcomes from well resourced or regional regulatory agencies conducted within 24 months. For IVDs, the Authority may carry out a risk based GMP inspection of a manufacturing site using cGMP guidelines, with a fee separate from the marketing authorisation application fee, and must consider previous satisfactory inspection reports from ZAMRA or other recognised competent authorities where it cannot inspect itself. Documentary proof of ISO 13485 compliance and an ISO 13485 certificate are mandatory dossier items, and the grant of IVD marketing authorisation requires the Authority to be satisfied that the product is manufactured in compliance with cGMP requirements.

statement: MCAZ's Strategic Plan 2026 2030 assigns the Medical Devices Unit responsibility for 'Factory inspections (cGMP) of condom and glove manufacturing facilities', alongside the regulation and quality conformity assessment of male condoms (SI 183 of 2005) and medical gloves (SI 1 of 2006). The Medical Devices Unit is listed separately from the Microbiology Unit and from the medicines licensing and inspection functions. No ISO 13485 certification requirement, notified body system or third party audit recognition is prescribed in the device regulations, which impose no quality management system obligation: approval turns on the product meeting the Second Schedule standards.