Change control by country

After registration, the certificate holder must notify AKBPM of any change to the documentation on which registration was based and file an amendment request; AKBPM registers the amendment in the register (if the approved change requires amendment of the registration decision) or refuses it depending on its type, within 30 days of receipt of the change documentation; implemented via e Albania service No. 15129 (30 working days, free of charge).

During the validity of the homologation decision, the holder and/or operator must declare immediately to ANPP: any modification of the elements of the initial declaration (Art. 19 dossier); and any prohibition or restriction imposed by the competent health authority of the country of origin or of any other country where the device is marketed, plus any new information that could influence the safety assessment of the device.

Any modification of a homologation decision must be submitted to ANPP before implementation; modifications are categorised (administrative / technical / performance safety efficacy materiovigilance, each requiring a distinct application) and graded minor, major or moderate by risk impact; minor modifications not affecting the decision's details and not requiring continued surveillance may be submitted within 12 months following implementation. Modification filing requires payment of a redevance.

Any transfer or cession of the homologation decision gives rise to issuance of a new homologation decision by ANPP, and may only benefit a duly agréé pharmaceutical establishment after examination of an administrative dossier.

Approved modifications and changes do not restart the registration clock: the product keeps its original 5 year validity and expiry date.

Changes to a registration certificate, the issue of duplicates of registration certificates and the examination needed to enter changes into the registration dossier are carried out by the authorised body (Ministry of Health), with the examinations performed by the Expert Organisation. A state duty is charged for the state registration of medical devices, and the same Law on State Duty fixes a separate, lower multiple for re issuing a registration certificate in connection with changes that do not affect the safety, effectiveness and quality of the product. Where the packaging or labelling of a medical device changes, import with the previously approved packaging or labelling is permitted for six months after the changes are made to the registration documents.

outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: An ARTG variation is limited to the same kind of device; variations are made under s 9D(1) of the Act and must meet the s 41BE criteria.

change creating a different kind of medical device (kind defined by unique product identifier for Class III/AIMD/Class 4 IVD and companion diagnostics, reg 1.6); change to the manufacturer's quality management system or design controls (e.g. acquisition, bankruptcy, death, winding up); change of legal manufacturer without a sponsor transfer

Implementing a variation to an ARTG entry before the Secretary has approved it breaches a condition of inclusion in the ARTG.

Substantial changes to an ongoing clinical investigation (Art. 75 MDR / § 13 Abs. 3 MPG 2021, affecting the investigation plan, the investigator's manual/brochure or the investigational product) must be notified to BASG; the notification is subject to a BASG fee of EUR 1,392 (tariff item XII.2.g of the tariff valid from 1 January 2026); changes not falling under Art. 75 cost EUR 949 (item XII.2.h).

Where any change is made to the information reflected in the documents listed in Parts 3 and 4 of the Rules for a registered medical device, that change must be state registered. Where the change alters data shown on the registration certificate, a new certificate is drawn up retaining the registration number, the date of registration of the change is recorded, and the new certificate's validity is limited to the remaining term of the previous one. Changes that do not affect data on the certificate are state registered without issuing a new certificate.

Bahrain distinguishes minor variations, which do not affect safety or performance (renewal of any certificate or official letter, artwork or label changes, IFU changes, authorized representative detail changes, device name or product identifier change, and adding devices to a licence for colour, package quantity or volume variants, not applicable to IVDs), from major variations, which do affect safety or performance (change of legal or physical manufacturer or address, manufacturing process change, design or detailed specification change, risk class change). A minor variation is approved by letter after review; a major variation requires a new registration application.

Without prior approval of the Licensing Authority, no new manufacturing project may be undertaken nor an ongoing project expanded.

Changing the physical infrastructure of the licensed premises without prior approval of the Licensing Authority in a way that adversely affects or could affect product quality is a ground for cancellation or temporary suspension of the licence.

Changes to the registration dossier are made for defined events (new name without changing properties; new medical indication; applicant/producer reorganization, name or address change; production site change; changes to technical regulations for domestic devices; adding/removing accessories; labeling/packaging changes; shelf life/storage changes; risk class change; IFU changes; size range additions). Applicants must apply within 3 months of the event, after passing the preliminary technical works and obtaining a positive RUP CEIZ conclusion.

The applicant must inform the Ministry of Health within one month of learning of: a change of production site address; the device losing medical product status due to changes in legal/technical acts; or a voluntary recall of the device from circulation by the producer.

A new state registration (not a variation) is required where an already registered device is produced by another producer or where a new production site is added for a registered device.

Modifications likely to have a substantial impact on the safety, health or rights of participants may not be implemented without a positive (possibly conditional) opinion from the full agreement ethics committee and, where applicable, ministerial authorisation under Article 34 of the Royal Decree of 18 May 2021.

statement: The inclusion of further items that correspond to a registration already granted is treated as a rectification, with the whole corresponding documentation to be submitted, and is allowed only where the items share the same risk classification and group. · article: Numeral 5.10.2

statement: Rectification, which preserves the number, code and validity originally granted, is available for modifications that do not imply a substantial change — for example variation in secondary components, packaging, labelling, design, power source, manufacturing processes, shelf life, or change of corporate name of the manufacturer or the holder. The requirements are a letter of request stating the type of rectification, a new Form 027 containing the rectification and the date of the last rectification, the original registration certificate, the technical documentation supporting the change, and proof of payment of the corresponding fee. · article: Numeral 2.10 and numeral 5.10

A request to amend the name and/or address of the manufacturer of a medical device must be accompanied, among other items, by an updated letter of authorisation by which the manufacturer authorises the performance of tasks relating to the entry of the device in the Register on the territory of Bosnia and Herzegovina (original or notarised copy in the manufacturer's country), the certificate of conformity (EC certificate), the certificate of conformity (EC Design Examination) where applicable, the manufacturer's declaration of conformity against the European directive, and proof that the device is marketed in the manufacturer's country or in one of the EU countries ('Free Sale Certificate' or similar document), each as an original or a notarised copy in the manufacturer's country. A request for amendment may relate to only one certificate of entry; a request for supplement (dopuna) may likewise relate to only one certificate and only to devices covered by a single declaration of conformity sharing the same GMDN, EMDN or EDMA code.

During the period of validity of the certificate of entry the holder must inform the Agency in writing of every change, renewal or amendment of the issued certificate or of the submitted documentation. One or more amendments may be applied for. The changes that must be applied for are enumerated and include: change of the manufacturer's name and/or address; change of the name and/or address of the certificate holder; change of the certificate holder; change of the device names; change of the device manufacturer; change, deletion or addition of a place of manufacture; changes in the finished product test procedure (change of standards and methods); change of the appearance and method of labelling of the outer and/or immediate packaging; amendment of the form, packaging or dimensions of the device; change of the device class; change of the period of use; change of storage conditions; change in the method and place of issue of the device; and other changes.

A marketing authorisation holder must inform BoMRA of any significant change that could reasonably be expected to affect the safety or effectiveness of a medical device and submit a variation application under the Medical Devices Variation Guidelines (BOMRA/ER/MED/P09/G01). Changes so fundamental that they alter the terms of the registered device cannot be handled as a change and require a new dossier; any other change must be notified to the Authority immediately.

Following an alteration, packaging, labels and instructions for use are subject to a 120 day period counted from publication of the alteration (run out/use of previously approved materials), per ANVISA's official RDC 751 Q&A.

Products with innovative technology or indication are treated distinctly: the Registro FAQ states that for such products the missing items lead to non approval (não anuência) or summary refusal of the petition, i.e. innovation outside an existing registration requires proper application, not a simple alteration.

Any modification of formula, composition elements or quantities, or addition, subtraction or innovation introduced in the making of a registered product requires prior and express authorization.

The only change control rules in Brunei health product law are for medicinal products: an applicant must notify changes to application information within 14 days (Act, s. 11(5)), and a product licence holder must forthwith inform the Authority of any material change in the specification, constituents, composition, manufacturing methods, quality procedures, storage arrangements, indications, label or leaflet of the medicinal product (Rg 2, Schedule 1, para. 2). The Ministry of Health's variation routes (MaV, MiV PA, MiV N) are for registered medicinal products. No variation or change notification route exists for medical devices.

Changes to a registered device or applicant data are filed as an application for change in the registration (промяна в регистрацията) on the official BDA form under ЗМИ Art. 27(3) (devices) / Art. 28(7) (IVDs); a change fee per the tariff applies, and address changes are notified within 14 days.

Article 4 defines a product variation as an update covering major and minor variations: a major variation is one that may strongly and/or directly affect quality, safety and efficacy (guideline point 7); a minor variation is administrative or a small change that does not strongly and/or directly affect quality, safety and efficacy (point 8); a simplified minor variation is an administrative or small change that does not affect quality, safety and efficacy (point 9). Article 5 adopts the Guideline on variations of pharmaceutical products dated 26 March 2019 as the technical document for the procedure.

Article 10 of Prakas 1258 provides that medical and dental devices with a different trade name, presentation, size or manufacturing plant must each hold a separate visa registration, so such differences cannot be handled as variations of one registration.

Article 11 provides that where the certificate holder is found to have varied a product without authorisation, the Ministry of Health may suspend, withdraw or cancel the visa registration certificate or impose an intermediary fine under the Law on the Management of Pharmaceuticals.

Variation requests may be made through a manufacturing establishment, a pharmaceutical import export establishment or a representative office holding a Ministry of Health decision (Art. 6). The dossier comprises the application in the national language, the visa registration certificate (copy, or the original where the variation affects certificate particulars), a letter from the certificate holder explaining the reasons for the variation, and the technical documents specified in Article 5 (Art. 7).

Prakas No. 4206 ABS/OABS authorises variations to products that already hold a Ministry of Health visa registration certificate, on the basis of information, evidence and specific documents from the certificate holder justifying the change (Art. 1); it applies to products whose certificate is still valid (Art. 3); and for its purposes 'pharmaceutical products' means modern medicines, traditional medicines, vaccines, health supplements, health support products, medical devices and reagents (Art. 4, last paragraph).

Article 10 provides that any variation procedure not set out in the Guideline on variations of pharmaceutical products obliges the certificate holder or manufacturer to apply for a new visa registration of the product.

Before making a listed change the manufacturer must apply to the Minister for a licence amendment: a significant change to a Class III or IV device; a change that would affect the class of the device; a change in the manufacturer's name; a change in the device's name; a change to the device identifier (across a system, test kit, group, family or group family); and, for Class II devices, a change to the medical conditions, purposes or uses for which the device is made, sold or represented. Other changes are handled internally and disclosed in the annual s.43 confirmation.

A new (rather than amended) MDL application is required where the product is a new device to the market or the change goes beyond amendment scope, notably a change that would affect the classification of the device under the Schedule 1 rules (s.34(b)); s.34 amendments preserve the existing licence.

A manufacturer who is issued a new or modified quality system certificate for a licensed device must submit it to the Minister within 30 days after it is issued.

Any device that, after verification of conformity and obtaining the registro sanitario, undergoes modifications in design, manufacture, intended use, raw materials or components, performance, labeling or other relevant characteristics must notify ISP; if the modification is significant, a new registro sanitario is required.

At the titular's request, ISP may modify the registro sanitario by reasoned resolution, provided the requested changes do not constitute a significant modification that could affect the device's safety and/or performance, or that imply alterations in design, chemical composition of the manufacturing material or main component, biocompatibility, energy source or manufacturing processes — those cases constitute a new registro sanitario. A modification prestación exists (catalog code 9100017).

Substantive changes to a registered Class II/III device (design, raw materials, production process, intended scope of use, method of use, etc.) that may affect safety or effectiveness require change registration (变更注册) applied for with the original registering authority.

Changes to a registered device other than those requiring change registration must be filed (备案) with the original registration authority within 30 days from the date of the change.

Modification requests for registros sanitarios and permisos de comercialización are processed automatically, within the 2 day term of Art. 22(b) and with later document review; INVIMA approves modifications demonstrated not to affect the device's safety and effectiveness.

Titulares of registros or permisos wishing to withdraw their products from the market must inform INVIMA in advance; permiso holders of controlled technology equipment without representation in Colombia must guarantee in country technical support for the permit's validity.

significant change affecting safety/effectiveness; change in design; change in chemical composition of material; change in energy source; change in manufacturing processes

An existing registration or marketing permit cannot be modified when a significant change may affect safety or effectiveness, including changes in design, chemical composition of materials, energy source or manufacturing processes; a new registration is required instead.

Changes to registration conditions require approval by the national regulatory authority BEFORE implementation, except changes declared to be notification type; applications use the Regístrelo post registration change form digitally signed, plus the requirements listed per change type (holder name change, manufacturer name change, holder change, representative change, product name change/expansion, label design change, code cancellations, local distributor changes, manufacturer change, family/group/system/kit composition change, manufacturing site change, code/model/description change, presentation changes). Each change type carries its own document set and the Decreto 32780 fee.

The original 6 month transition to file a post registration change submitting the product label (if not already in the sanitary registration file) was extended by a 2024 reform to eighteen months counted from the entry into force of that reform.

A change to the product that entails a variation in risk classification is considered a new product and requires a new registration (per class requirements in numerales 11/12/13); a change of specific use (indication) that implies a change in risk classification also requires a new registration; all other post registration changes follow numeral 18.

The following are processed as notifications (not prior approval changes): label design change, cancellation of codes, change or expansion of local distributors, and change of the holder's address without change of origin; distributor changes require the new distributor to hold a valid operating permit.

The AIRP fee schedule prices two categories of post authorisation change — major variation (variation majeure) and minor variation (variation mineure) — at every device class, with the major variation fee equal to the full base registration fee and the minor variation fee at a fraction of it. This establishes that a variation procedure exists and what it costs, but the procedure document does not state the criteria distinguishing a major from a minor variation, nor the documents or the decision clock for either.

Where documentation filed with the initial notification of placing a device on the market changes, HALMED requires a notification of amendment referring to the last classification reference of the Agency's receipt certificate (530 09/...), stating clearly what changed and enclosing the relevant notification form, the new product list where it changed, the proof of payment, and any other document depending on the change. HALMED notes by way of example that a change of the manufacturer's address automatically triggers a change of the labelling, instructions for use, declaration of conformity and conformity certificate.

A distributor or importer that translates information supplied by the manufacturer or changes the outer packaging of a device already placed on the market must inform the manufacturer and the competent authority of the member state in which it plans to make the device available at least 28 days before making the relabelled or repackaged device available, and must supply a sample or mock up on request. Croatian law makes failure to give that notice an offence punishable on the legal person with a fine in the range of 50.000,00 to 200.000,00 kuna.

Modifications to a device are classified as significant or non significant: if significant (per Article 11 of the Reglamento, Chapter I), a new registration process not a prórroga is required. For renewal and modification the manufacturer must declare the modifications suffered during the registration's validity with evidence they do not affect safety, efficacy and effectiveness; CECMED specialists classify them. E 132 25 epígrafe 3.26 additionally allows CECMED to warn a manufacturer to start reclassification of a device on the market when new evidence changes its risk. Modification of a registered device is a priced trámite (fee rows A54 14 to A60 14).

A distributor or importer that carries out the relabelling or repackaging activities described in Article 16(2) MDR must inform the manufacturer and the competent authority of the Member State in which it plans to make the device available at least 28 days before making the relabelled or repackaged device available, and must on request provide the manufacturer and the competent authority with a sample or mock up of the relabelled or repackaged device, including any translated label and instructions for use. For Cyprus the competent authority to be informed is CYMDA.

A sponsor that has made a substantial modification to a clinical investigation of a medical device must inform CYMDA by sending the relevant form (in Greek or English) to cymda@mphs.moh.gov.cy. CYMDA publishes the form as a separate service on its portal.

Since 7 March 2024, notifications of MDR Art. 82 other clinical trials, applications for substantial modifications of such trials, and reports of serious adverse events during them are submitted through ISZP; IVDR serious adverse event reports use the MDCG 2024 4 form via RZPRO or e mail khzp@sukl.gov.cz (Czech or English) until EUDAMED is used.

A notified person must report a change of its § 23 notification data via ISZP within 30 days of the change; the change notification counts as confirmation of the correctness of all other notified data. No report is needed for data verifiable remotely from the base registers.

Changes to an authorised clinical investigation that may materially affect the safety, health or rights of trial subjects, or the robustness or reliability of the clinical data, require prior authorisation from the Danish Medicines Agency before implementation. The application is submitted by e mail to DKMA and the ethics committee with updated and clearly marked (e.g. track changes) documents per MDR Annex XV; DKMA has 38 days to process. Trials authorised before 26 May 2021 use a separate scheme with the original Regional Ethics Committee.

Manufacturers, authorised representatives, importers, distributors and specialty retailer owners that have notified/registered with the Danish Medicines Agency must notify any change to the registered details, including cessation of marketing or business; per DKMA, changes are submitted via a new registration form ('ændring i registrering'), added risk classes require a new registration, and cessation is reported as 'ophør i registrering'.

statement: Where the registration has undergone changes of any nature the holder must file the modification application at the same time as the renewal and pay the fees for that transaction; where a modification is filed within the six months before expiry, issuance of the modification carries the automatic renewal of the registration, with the renewal fee paid at the time of filing. DIGEMAPS operates separate modification transactions for a change of representative, title holder, company name, excipients, shelf life, trade mark, inclusion of a co distributor, primary packaging, manufacturing process and control method, and packaging/labels/insert updates for sanitary products. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: market oversight · localApplicationRequired: Yes · targetDecisionRetained: Yes

Changes handled by modification rather than new registration include: commercial name; product owner/registration holder/manufacturer changes; name or address changes; model changes not affecting risk or approved characteristics; raw material composition not affecting risk; packaging material not affecting sterility; commercial presentations; components/accessories; sterilization method; brand; import route; manufacturing process; storage conditions; insert updates; labeling updates; new manufacturing site; new importer/distributor; new items; shelf life variations. The holder notifies/files these through the VUE modification form with supporting documents per ARCSA instructivo; simpler cases follow the free notification route (NDM list of Resolución ARCSA DE 2023 005 AKRG).

A new sanitary registration is required for: (a) model change significantly modifying design, functionality or operating principle causing a change of risk level; (b) change of intended use changing the medical purpose and risk level; (c) change of conditions of use/mode of application; (d) changes in chemical composition of raw materials or energy source that change the risk level; (e) change of the qualitative quantitative formula of formulated devices. When a new registration is granted for these cases, the previous registration is cancelled within 90 days (after any authorized stock exhaustion).

For nationally manufactured devices the holder may not manufacture or market devices incorporating Art. 42 modifications without ARCSA prior approval of those modifications; for foreign manufactured devices the holder may not import or market devices incorporating modifications when they affect the label and/or insert without prior approval.

Changes are tiered: 'Do and tell' (applicant name/address, non significant label changes) consignments not seized but change must be filed; 'Tell and do' (codes, manufacturing site transfer, shelf life, sterilization method, manufacturer name, packaging, significant label changes) consignments not placed on market without an initial acceptance number; 'Tell, assess and then do' (material/substance/component, design, intended use) marketing suspended while EDA adjudicates whether it is a variation or a new device requiring a new registration file.

Variations are reviewed on a Normal Track (per the administration's waiting list) or Fast Track (priority); the applicant receives a response within 8 working days (normal) or 5 (fast), file review takes 25 working days (normal) or 10 (fast), and a suspension for missing documents lasts at most 90 working days before cancellation. A one year grace is granted for placing the varied device on the market from acceptance of the variation request; if the applicant does not follow up for 60 working days the file is archived and the request cancelled.

A device may rely on the extended transitional periods of Regulation (EU) 2023/607 only if there are no significant changes in its design and intended purpose; a significant change in design or intended purpose moves the device out of the transitional regime and requires MDR conformity assessment.

The conditions and procedure for notifying the placing on the market of a custom made device, a significant change made to a custom made device, and the first distribution of a device in Estonia are laid down by regulation of the minister responsible for the field, made under § 26(5) of the Medical Devices Act.

EFDA classifies post approval changes to a registered medical device into three categories. Category 1 changes are critical changes that require a new pre market product registration application, including change to the intended purpose or indications for use (unless it is a reduction not arising from safety or performance concerns), change to the risk classification, software changes affecting safety, quality and performance, addition of variants outside the permissible grouping rules, changes to the medicinal substance in a device with an ancillary medicinal product, and addition of devices with different proprietary names or models that do not meet the grouping criteria. Category 2 changes are major changes requiring evaluation and EFDA endorsement before implementation, such as changes to manufacturing or sterilization facilities or processes. Category 3 changes are minor changes that may be implemented immediately. Where several changes are filed together the assessment follows the highest category in the application. Specified changes — for example labelling changes that only add or remove languages not required by EFDA — do not require a change notification at all.

The manufacturer must inform the notified body that approved its quality management system of any plan for substantial changes to the QMS or the device range covered; the NB assesses the changes, determines the need for additional audits, verifies the QMS still meets Section 2.2 requirements, and any approval takes the form of a supplement to the EU quality management system certificate (Annex IX Section 2.4 MDR).

Changes to the approved device require approval from the notified body that issued the EU technical documentation assessment certificate where the changes could affect the safety and performance of the device or the conditions prescribed for use; the manufacturer must inform the NB of planned changes, and the NB decides whether a new conformity assessment under Art. 52 is required or a supplement to the certificate suffices (Annex IX Section 4.10 MDR). Under the type examination route, planned changes to the approved type must be notified to the NB that issued the EU type examination certificate (Annex X Section 5.1 MDR).

All notifiable operators must report to Fimea material changes to the data they have submitted, and operators under 49 § 1, 3 and 5 mom must immediately report if they no longer place a specific device on the market or make it available.

Substantial modifications (modifications substantielles) to an authorised clinical investigation follow a dedicated CPP procedure (Arts. R1125 11 to R1125 13 CSP) and CPP silence at the end of the period equals rejection of the request; ANSM also finalises evaluation before any MS request can be filed.

Changes to a registered product are made by registering a variation. Type I variations are those 'of less significant importance' and are split into Type IA and Type IB; Type II variations are the remainder. A variation is decided within 20 calendar days (Type IA) or 40 calendar days (Type IB); a Type II variation follows the 3 month primary registration clock. Registration of a variation does not change the registration validity period, and a product available before a variation may be circulated in Georgia until expiry of its shelf life.

If the federal higher authority intends to reject a substantial modification of a clinical investigation/performance study, it informs the sponsor within 37 days of receipt of the notification of the substantial modification; the period extends by seven days if the authority consults external experts (the extension and its reason must be communicated within 20 days).

A change of a registered premise must be notified to the Authority.

The Authority shall suspend or cancel a licence if information submitted in respect of the registration changes or is found to have been inaccurate; the applicant may re submit new information after suspension or cancellation.

Any significant change that could reasonably affect safety, quality or performance of a registered device requires a variation application and the variation fee: changes to manufacturing process/facility/equipment, quality control procedures, design (including performance characteristics, specifications, software, accessories), and intended use (including contraindication changes and expiry period changes).

A substantial modification (ουσιώδης τροποποίηση) of an EOF approved clinical investigation requires a new application following the same dossier structure (General Part per Annex XV Ch. II MDR + Special Part limited to the modified elements), with the Greek amendment application form and a fee of EUR 500; substantial modifications of Art. 74(1) studies must be notified to EOF at least 30 days before implementation in Greece.

Each request for modification of EOF register certificates (βεβαιώσεις) requires submission of a modification application with a fee (παράβολο) of EUR 100 (plus 2.4% stamp duty per the 2022 form, abolished from 01 12 2024 by Law 5135/2024).

Changes to a device inscription fall into two categories — those requiring notification and those requiring authorisation from the DRCPFA — and are filed on form F AS f 10, 'Solicitud de Actualización de Inscripción Sanitaria de Productos Afines'. NT 37 Art. 6 enumerates the change types, including change of holder (6.1), change of the manufacturer's or holder's corporate name (6.2) and addition of an alternative manufacturing plant (6.12). All documentation must be in Spanish, with official translations for foreign documents.

Major Changes (changes that could be expected to affect safety, quality or performance) require MDD approval via a Change Application before implementation; Minor Changes may be implemented before approval but must be notified.

For Minor Changes, the LRP may implement the change before approval but must notify MDD by submitting a Change Application within 24 weeks from becoming aware of the change.

MDD has discretion to require a new listing application based on the information submitted in a Change Application; for change of the manufacturer's name the LRP must submit a new listing application instead of a Change Application.

The listing becomes invalid immediately if the device undergoes changes without notifying MDD within the specified timeframe or obtaining prior approval; a Major Change implemented without prior approval means the device is no longer regarded as listed.

Economic operators must report any change in their registered EUDAMED Actor data within 7 days of occurrence, via cégkapu e paper referencing the original case number (fee 21,600 Ft, fee table II.5), and must simultaneously make the change in EUDAMED.

Distributors must report changes to their notified data — including newly distributed devices — within 90 days of the change occurring (fee 21,600 Ft).

There is no Icelandic variation, amendment or change notification procedure and no variation fee, because Iceland holds no national device approval; change control is the Union change control regime, which has legal force in Iceland under Article 2 of Act No. 132/2020. Under MDR Annex IX point 4.10, changes to an approved device require approval from the notified body which issued the EU technical documentation assessment certificate where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device; the manufacturer must inform that notified body, which assesses the planned changes and decides whether they require a new conformity assessment under Article 52 or whether they can be addressed by a supplement to the EU technical documentation assessment certificate, which it issues if the changes are approved. The parallel rules are Annex IX point 2.4 (substantial changes to the quality management system or to the device range covered must be notified to the notified body that approved the system; approval takes the form of a supplement to the EU quality management system certificate) and Annex X points 5.1 5.2 (planned changes to an approved type require the approval of the notified body that issued the EU type examination certificate). In Icelandic law the manufacturer's side of this is Article 21 of Act No. 132/2020 (technical documentation must be kept up to date) and Article 22 (quality management system, risk management system and post market surveillance system must be established, maintained and updated), and the agency can require information and data under Chapter VII of the Act. The only change related charge in gjaldskrá No. 1529/2025 is for changes to a clinical investigation (ISK 106,800); there is no device variation fee line.

Outcomes are: notification (minor changes, within 30 days), prior approval with deemed approval on authority silence (major changes), or a fresh licence application (change in constitution of the licensee, within 180 days).

Major changes listed in the Sixth Schedule (construction material; design affecting quality, indications, performance or stability; intended use; sterilisation method; approved shelf life; name/address of manufacturer or authorised agent; label; manufacturing process; primary packaging) require prior approval before implementation: CLA/SLA decision within 45 days for manufacture licences (deemed approved on silence); within 60 days for import licences (deemed approved on silence). Minor changes are informed within 30 days of taking effect.

A change in constitution of the licensee (including the overseas manufacturer that executed the power of attorney) triggers a fresh licence application within 180 days of the change; the existing licence remains valid until the fresh licence is issued or the application is rejected.

An izin edar change (perubahan) is available for changes of: size; packaging; labelling; accessories/annexes to the authorization; and name/address of the representative empowered by the manufacturer processed without changing the izin edar number. OSS standards additionally provide variation services for changes of technical responsible person, product type and premises layout.

Any change other than size, packaging, labelling, accessories/annexes or the authorized representative's name/address requires a new izin edar application (e.g. product, manufacturer or functional specification changes).

If the declared use of a laboratory item changes from research only to in vitro diagnostic (IVD), the product must be registered in the directorate's registration system and comply with device requirements — the RUO exemption ends.

Substantial modifications to an ongoing clinical investigation must be notified to HPRA for assessment before implementation (Notification of Substantial Modification form, submitted via the CESP steps); refusal of a substantial modification authorisation is appealable under S.I. 261 of 2021 reg. 15(1)(c).

Substantial modifications to HPRA approved IVD performance studies are notified per IVDR Article 71 via CESP using the Appendix 2 format of AUT G0176 2 (description, justification, impact, affected documents); a positive research ethics committee opinion may also be required before implementation.

Changes to a registered device are classified by the manufacturer as 'material' (מהותי), 'non material' (לא מהותי) or 'administrative' (אדמיניסטרטיבי); it is the registration holder's responsibility to verify the nature and classification of each change with the manufacturer and file the change application accordingly. Combination rules: several material changes, or material combined with non material/administrative, are filed as one 'material' application; non material combined with administrative is filed as 'non material' (one row for the highest ranked change). An EU reclassification increase in risk class requires a 'material' change application. Categories marked '^V' in the change procedure may be filed through the fast 'non material' channel despite being manufacturer classified material.

When filing a renewal application (regular or fast track), only 'non material' and/or 'administrative' change requests may be bundled in addition, with the appropriate declaration wording attached.

In case of modification of the communicated data or cessation of activity, the distributor must update the information in the national database within 30 days of the date of the modification or cessation of activity.

Changes to approved items split into: partial change approval for anything beyond Ordinance defined minor changes (Art. 23 2 5(13)) and notification for minor (軽微な) changes (Art. 23 2 5(14)); the certification route mirrors this split via the certifying RCAB (Art. 23 2 23(7)/(8)).

Minor (軽微な) changes to approved items are notified to MHLW within 30 days after making the change.

Not minor (thus requiring approval level change review): adding/changing/deleting intended use or effects; changes to methods for inactivating/removing pathogenic factors; and any change MHLW deems to affect quality, efficacy or safety (Rule Art. 114 25(1)); IVD analogs in Art. 114 25(2) (incl. changes to reaction system components).

No change may be made to materials covered by Article 3 of Law 12/2013 (which include devices and supplies) except in accordance with the basis approved at JFDA.

Changes to a registered supply, sterilant or disinfectant handled as separate JFDA services include: leaflet (نشرة داخلية) amendment, outer and/or inner packaging amendment, storage condition change or shelf life extension (or reduction), addition of a pack size, composition change, and adoption of a final specification.

The applicant must initiate the dossier change procedure within 90 calendar days from making changes to documents contained in the registration dossier.

On national dossier amendments the registration certificate is generated under the previous number indicating the change introduction date, issue date and validity.

Changes may be made in notification (уведомительный) order for: expiry updates of dossier documents; changes by manufacturers of class 1 or non sterile class 2а devices that passed QMS assessment; manufacturer/representative name address changes; trademark renaming; removal of a model from the certificate.

Changes requiring registration of a new device include: changes altering the functional purpose and/or operating principle; adding models not meeting the one certificate criteria; simultaneous change of manufacturer and manufacturing site information.

Changes to a registered medical device that can affect its safety, quality or efficacy must be approved prior to the modified device being supplied in Kenya, unless otherwise indicated; applicants are required to notify changes concerning registered medical devices to the Authority, and each simultaneous change must be assessed separately.

Certain changes do not qualify for change notification and require submission of a new CSDT application, including: change to the intended purpose of a registered medical device; change to the risk classification of the device; change to the medicinal substance in a device incorporating a medicinal product in an ancillary role; and adding devices with different proprietary names into a single family listing.

Under rule 13 of the 2022 Registration Rules the Board may, by written notice, vary the certificate and enter the variation in the Register; certificate holders must report any quality and safety changes or any defect which could impact patient safety of a marketed product.

statement: Persons registered under paragraphs 28 and 29 of Cabinet Regulation No. 461 must inform the State Agency of Medicines within 10 working days of changes to the information they submitted. An authorised representative established in Latvia must inform the agency immediately of changes to its paragraph 4 information. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: Yes · targetDecisionRetained: No

statement: A distributor carrying out any of the activities referred to in Article 16(2)(a) and (b) of Regulation (EU) 2017/745 must inform the State Agency of Medicines at least 28 days before making the newly labelled or re packaged device available on the Latvian market, and on request submit to the agency a sample or mock up of the newly labelled or re packaged device, including any translated label and instructions for use. Within the same 28 day period the distributor must submit a notified body certificate covering the type of device concerned and confirming that the distributor's quality management system meets Article 16(3). · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

Registration modifications are handled as their own dossier type: the health technology unit processes registration, renewal, modification and withdrawal dossiers (§7.2.2 list item 2), and the supplier must inform the MOPH of any change or modification to the information given at registration and keep that information updated (§6.2 provision 21). Under Decision No. 1704/1 of 12 September 2017, Article Three, importers and distributors must also keep the conformity certificates of the devices recorded in the MEDREG system up to date, failing which the MED Import system refuses invoices for items whose certificates have expired.

Changes to the declared data must be reported to the Amt für Gesundheit within 30 days of the change occurring: for health institution manufactured products (EWR MepV Art. 12(3); EWR IvDV Art. 14(3) for IVDs) and for custom made devices (EWR MepV Art. 13(2)).

Manufacturers (or authorised representatives, system/pack assemblers sterilisers) must inform VASPVT of changes to the data registered under HSL Art. 59 1(3) and of discontinuation of placing the registered devices on the market.

The applicant must inform the notified body that issued the EU type examination certificate of any planned change to the approved type or its intended purpose and conditions of use; changes that may affect conformity with the general safety and performance requirements or the prescribed conditions of use require the notified body approval, issued as a supplement to the certificate, and changes to the intended purpose and conditions of use (other than their limitation) necessitate a new conformity assessment application.

Filing (Class I/IIa) changes require written notice to ISAF at least 5 working days in advance.

Registration data changes in listed categories (including label/IFU style, holder administrative data, non substantial improvements and other data not affecting safety or quality) require written notice to ISAF at least 20 working days in advance; other changes require ISAF pre approval; changing the device name is prohibited and requires a new registration application.

Changes to registered devices fall into three categories: Category 1 changes affecting safety and performance requiring new registration (e.g. new intended purpose, risk class change, non permissible variants); Category 2 changes requiring MDA evaluation and endorsement prior to implementation; Category 3 changes implementable immediately upon submission of complete documents through MeDC@St. A category confirmation request may be made to MDA beforehand.

MDA/GD/0072 'Change Management for Registered Medical Devices' (first edition, 2026) is published and will replace MDA/GD/0020, but is not yet implemented; it takes effect only upon the official launch of MedCAST 3.0, and until then MDA/GD/0020 remains applicable and in force.

Category 1 triggers for a new registration application include: change to intended purpose (except indication reductions not driven by safety/performance concerns), change of risk classification, addition of devices beyond permissible grouping variants, certain IVD cluster variant additions, and addition of devices under different proprietary names.

Changes to a Maltese registration are filed as an amendment rather than a new application. The Authority maintains MT MDF03, an application form for revision or withdrawal of a medical device registration, and MT MDF02 and MT MDF05 both carry an amendment/withdrawal track that requires the organisation registration number or the per device MMA reference number to be quoted. Amendment fees are: EUR 100 to change organisation registration details (distributor/importer, manufacturer or authorised representative), EUR 100 to amend a device notification, EUR 50 to amend MDRP details. Withdrawal incurs no charge. The fee schedule marks these amendment applications as eligible for fast track handling at double the fee.

outcomes: prior approval amendment or variation; new registration or new application · description: Any modification to registered conditions of Capítulo IX devices requires prior authorization by the Secretaría with supporting technical, scientific and legal information (RIS Art. 184); distributor changes add Spanish label/counter label drafts. New models of the same product line and manufacturer with technological advances require a NEW registration (RIS Art. 84). Authorized modifications grant up to 240 working days to exhaust existing labeling stock (RIS Art. 189, reformed DOF 31 05 2021).

New models of an already registered device line from the same manufacturer with technological advances (RIS Art. 84); Changes to registered conditions outside the modification scope, including unauthorized product or raw material manufacturer changes which trigger cancellation (LGS Art. 376)

Persons that have registered medical devices without CE marking are obliged to communicate to the Agency any modification occurring after the registration of the medical device in the State Register of Medical Devices, including the interruption of placing the registered medical devices on the market, and the changed data are entered in the State Register. A change of seat or name, or of the person responsible for placing the medical devices on the market, is entered in the State Register on the basis of documents issued by the Public Services Agency.

The authorised representative informs AMDM within 15 working days of any modification of the data entered in the RSDM, of the termination of the authorised representation agreement, and of the cessation of making the medical device available on the market. Deletion of the identification number from the RSDM is carried out at the request of the authorised representative in the cases provided for, or ex officio where the medical device no longer meets the conditions on the basis of which it was registered; ex officio deletion is ordered respecting the right to be heard under art. 90 of the Administrative Code, is reasoned, and is communicated with an indication of the remedy available.

Where the authorised representation agreement is modified, a new manufacturer registration application must be filed, accompanied by a reasoned letter describing the substance of the modifications made; the modified agreement and the reasoned letter are combined into a single PDF file. Where the manufacturer changes its authorised representative, that application must contain at least the name and contact data of the new authorised representative, and the status of the medical devices already registered in the RSDM whether they are taken over by the new authorised representative or are to be deleted from the register, with the reason for deletion stated.

An amendment to an IVD registration requires a request, a comparison of the label and packaging, a risk assessment with stability data, a comparison of ISO certificates, the manufacturer's explanation, and national reference laboratory results, non clinical study data or a clinical evaluation. For listed medical equipment and consumables, a request to change the listed information is uploaded to the electronic database within 10 working days of receipt in accordance with the working office's decision, and listing amendments are supported by the documents at §3.11.

statement: The entities entered in the register must file an application with the Institute for every amendment or supplement of the register data before introducing the change. The Institute issues the amendment decision within 60 days of submission of a complete application; if the application is incomplete the applicant is given 30 days to remedy it. Amendments that do not affect the safety and performance of the medical device are notified to the Institute and entered in the register without a decision. · changeControlRule: prior application; 60 day decision; administrative amendments notified

The registration holder remains responsible for the ongoing evaluation of the clinical data of its products as scientific knowledge evolves and must notify the administration in writing of any modification affecting those data or the content of the registration dossier of a device placed on the market. A new registration application must be filed for any change bearing on the nature of the medical device. Separately, the AMMPS checklist names three changes that trigger a new registration application: extension of the device's form, change in the composition of a kit or system on adding an element, and change of composition on adding an active substance. Change of the registration holder requires a transfer authorisation.

The administration decides on an application to update a device registration certificate within a maximum of twenty days from the date the complete dossier is filed; any refusal must be justified and communicated to the establishment concerned. The update may be recorded on the back of the original registration certificate. The notification letter for modifications must be drawn up in triplicate, signed and stamped by the legal representative of the establishment concerned, accompanied by a fiche signalétique in triplicate with its electronic copy, a copy of the registration certificate in force, and the documents justifying the change.

Changes to an existing notification (wijziging) and deregistrations (afmelding) are handled by Farmatec with a maximum processing time of 3 months; notifications already in NOTIS but not yet in EUDAMED can be mutated online in NOTIS until 27 November 2026, after which registration continues in EUDAMED.

If recorded WAND information ceases to be accurate or complete — whether through a change of circumstances (for example a change in the name of the manufacturer or sponsor), a lapse in any certification relating to the device, or otherwise — the sponsor must notify the correct details within 10 working days.

Where the category of change selected by the applicant is inappropriate, NAFDAC will advise the market authorization holder to amend the category as deemed appropriate.

Changes to registered devices fall into three categories: (1) Critical changes affect safety, quality and performance and require NEW registration; (2) Major changes require NAFDAC evaluation and approval prior to implementation and before placing on the Nigerian market; (3) Minor changes may be implemented immediately but still require prior NAFDAC approval before implementation.

New findings on the quality, safety or efficacy of a registered medical device are notified by filing an amendment application, and the rulebook enumerates fourteen changeable items: the manufacturer's name or address; the applicant's name or address; the applicant; the device name; the manufacturer of input components; a new place of manufacture for part or all of the production process named in the certificate; the finished product testing procedure (standards and methods); the appearance and manner of outer or inner labelling; the shape, packaging or dimensions of the device; the class; the shelf life; the storage conditions; the manner of dispensing or selling; and the place of dispensing or selling. Where the documentation filed under Article 7 or Article 8 at first registration is unchanged, the applicant may refer to it instead of resubmitting.

The holder of a parallel import approval must follow all changes that occur to the device in the country from which it is imported and notify the Agency within 60 days of the date the change enters into force in that country, attaching proof from the competent authority of the source country that the change has been approved.

An economic operator entered in one of MALMED's registers must keep the registered data up to date: registered manufacturers, wholesalers and specialised shops must regularly update the information submitted and file documentation on all changes affecting public health. Submitting false data, a false statement or false proof in the procedure for entering a medical device in the register of medical devices, or in the procedure for obtaining a parallel import approval, is a criminal offence.

Notified bodies must inform Direktoratet for medisinske produkter about all certificates issued, amended, extended, suspended, withdrawn or refused (and inform other notified bodies about suspended/withdrawn/refused certificates).

Any variation in a registered medical device or registered manufacturer must be applied for through the variation service after registration; the service requires a justification letter for the variation and follows Ministerial Decision No. 113/2020 (fee 25).

The only change outcome the Medical Devices Rules, 2017 provide is a prior approval variation: under rule 17 the certificate holder applies to the MDB for prior approval of any change in particulars or any change affecting safety or performance, on Form 6/6A or Form 7/7A with the rule 63 fee, and the device must not be manufactured or placed on the market with the change until MDB approval. There is no alternative outcome routing a change to a new enlistment or registration application.

Under rule 17(3), upon receiving a change application the MDB may inspect the establishment to verify particulars, and the enlistment or registration holder shall not manufacture the medical device with the proposed change nor place it on the market until the MDB has approved the change; contravention of rule 17(1) or (3) can lead to cancellation or suspension of the enlistment or registration after an opportunity of being heard (rule 17(4)).

The rules contain no provision routing any change event (particulars, safety/performance change, representative change) to a new enlistment or registration application. The only fresh application triggers are expiry related: failure to renew within one year after expiry of a device enlistment/registration (rule 16(5)) or of an establishment licence (rule 7), where the authorization ceases and the application is treated as fresh.

Software and other updates that do not change the device's function do not require a change or update of the Registro Sanitario; spare parts, accessories and consumables are covered by the host equipment's registration. Compatible third party spare parts must be covered by a certification from the equipment manufacturer before marketing.

Applications to modify the marketing authorisations of medical devices do not alter the expiry date of the sanitary registration or of the NSO, which stays as originally granted.

Any modification to characteristic data of a device authorised by DINAVISA must be classified and notified. Type I modifications are of immediate implementation; Type II modifications must be authorised by DINAVISA before implementation. The corresponding fee must be paid for each modification and an Annex III sworn declaration is filed.

DINAVISA has 45 business days to evaluate the documentation required for Type II modifications and decide; inconsistencies are notified to the applicant, who has 60 business days from the first business day after notification to rectify. If the response introduces new information that raises further inconsistencies, the applicant has a further 30 business days. If the observations are not rectified in time or the technical evaluation is unsatisfactory, implementation of the modification is refused.

Where post registration or post notification modifications are detected that were not declared, DINAVISA proceeds ex officio to suspend the marketing authorisation until the position is regularised.

Changes to the device Registro Sanitario are granted according to their risk to health or their repercussions on quality, safety and efficacy; declared information changes are filed with a declaration jurida application plus supporting documents per specific directive. The TUPA 'Cambio en el Registro Sanitario de dispositivos médicos' procedure (PA9900E4FF, S/ 646.70, 30 business days) covers changes with significant repercussions on quality, safety or efficacy.

The holder (or certificate holder) of an imported device may request authorization to exhaust stock of existing inventory within a period not exceeding 30 days of the triggering event, via declaration jurada identifying lots/series/identification codes, quantities, monthly sales average, and transit invoices where applicable.

The distributor or local manufacturer of a device must inform the CDRRHR in writing within thirty (30) calendar days if it has ceased production or distribution of the device.

When applying for CMDR for a device previously authorized by CMDN, the MAH must provide a letter stating that the application is from CMDN to CMDR, with a copy of the CMDN attached.

Minor and major variations or amendments to CMDR and to CPR of IVDs are applied for through a dedicated CDRRHR service: PDF application by email, Document Tracking Number generated in the FDA Web Support System, application fee PHP 500 + 10 LRF (brand name change PHP 2,500 + 25; shelf life extension PHP 1,000), processed in about 19 working days.

Until 1 January 2031, entities that made notifications under the repealed 2010 Act must report changes of data (manufacturer/AR name and address, device trade name, notified body number) to URPL within 7 days of learning of the change, and must promptly report discontinuation of marketing, cessation of the AR function, or termination of the business.

Entities entered in the distributor register, the import/user register or the custom producer register must inform the President of URPL within 7 days of any change of name or address (not accompanied by a NIP change) and of any transfer of obligations (transformation, bankruptcy, legal succession); failure to complete corrections requested by URPL within 7 days is treated as non performance and the submitted data are deleted.

Distributors must transmit electronically to INFARMED changes and updates to the mandatory notification elements, including the date from which they ceased distributing a given device.

IMD registration includes a manufacturer declaration that, in case of termination of the local agent or the local agent being unable to serve, the manufacturer will provide direct support.

Persons who registered devices in the national database must communicate to ANMDMR any change occurring after receipt of the registration notice, including interruption/cessation of placing the registered devices on the market; ANMDMR updates the database and informs them within maximum 60 days.

Roszdravnadzor splits registration dossier changes into: (1) changes not requiring expertise on quality, efficacy and safety (administrative update service); (2) changes requiring such expertise; (3) a special change procedure for software using artificial intelligence technologies; a duplicate RU issuance service also exists.

Any variation to a registered medical device or IVD's information must be notified in writing to the Authority through an application in the approved format, as per the variation guidelines in force at the time of submission. A distinction is made between major and minor variations in accordance with those guidelines, with a difference in the applicable fees. An application for change on a registered or notified medical device is one of the submission types on the standard application form. Under the fee regulations, minor variations and annual retention are fee waived, while a major variation of a registered product is charged at 50 per cent of the initial registration fee.

Two change tracks: significant/material changes must be notified to SFDA within 10 days and require SFDA approval (with the MDMA application updated in GHAD and the change form submitted); non significant/non material changes are notified within 30 days without prior approval (by email to MDMA.IT@sfda.gov.sa, followed by GHAD update within 90 days). A device subject to a significant change may not be traded before SFDA approval.

For significant (جوهرية) changes, SFDA must be notified within 10 days of the change and its approval is required; the MDMA application(s) must be updated in the GHAD system with the 'Medical Devices Change Form' (Annex 1 of MDS G012) and related documents, and the changed device may not be traded before approval. Non significant changes are notified within 30 days without approval.

Any modification of the application dossier for a device marketing authorisation requires a variation request in accordance with the regulations in force; the composition of the variation dossier is fixed by a decision of the ARP Director General. The fee decree prices variations at two levels — major variation and minor variation — with distinct amounts per class. The classification criteria distinguishing a major from a minor variation are not stated in either instrument.

A request or notification is required for every amendment of Register data; ALIMS decides within 15 days. Changes that do not affect safety and performance (e.g. graphic design of packaging/IFU, text layout changes, adding another foreign language on packaging/IFU) are only reported (prijava) and entered in the Register without a decision, with a confirmation of the filed change issued. Changes requiring a decision include: change of AR, manufacturer, notified/appointed body, device name, class or category, shelf life, storage conditions, place of issue/sale, testing procedures/design/materials, and alignment with EU regulations with updated certificates (added 6/2023). The device must be placed on the market within 12 months of the amendment decision/notification.

GN 21 classifies changes into approval requiring changes (technical changes to Class C and D devices; review changes for Class B), notification changes, and administrative changes (6Aii/6Aiii); the expanded R7 list (effective 14 July 2025) exempts more changes from CN applications and no change notification application is required for Class A devices.

A new registration application (not a change notification) is required for: change in risk classification, change in intended use of the device, addition of a model that does not fulfil the grouping criteria, and change of the registrable drug in a device.

Changes to a registered device that affect particulars or its safety, quality or efficacy require the Authority's prior approval unless the change type is specified on the Authority's website as not requiring approval; the changed device must not be supplied until approval (reg 49(3)); offences up to $20,000/12 months.

Changes to nationally notified/registered data are reported to ŠÚKL by filing a hlásenie zmeny (change report), which is a charged service under the ŠÚKL Sadzobník výkonov a služieb; the same schedule charges device code creation/update requests and technical documentation assessment. For clinical investigations, assessment of a substantial change notification is separately charged (500 €, sadzobník item 96.1.58).

Changes to registered data or cessation of activity must be reported to JAZMP within 8 days of the change arising, for distributors (Art. 15(4)), importers/manufacturers/authorised representatives/system producers (Arts. 41 44) and device registrations including legacy ZMedPri registered devices (Art. 45).

A licensee must notify the Registrar in writing of any change to the particulars furnished in the application or entered in the register occurring after issue of the licence (Regulation 5(7)); licence amendments are handled under the SAHPRA amendment process (MD10 2025/26) with an amendment fee of R5,500, and product list updates are notified separately (MD09 2025/26).

Updates to the product list(s) of a licensed establishment are notified to SAHPRA under Regulation 5(7) as a separate notification process (SAHPRA MD09 2025/26), keeping the licence's device listing current.

Changes to approved/certified/notified particulars (e.g. location changes) require change approval (변경허가), change certification (변경인증) or change notification (변경신고) to the MFDS Commissioner; the procedures and criteria are delegated to the Prime Ministerial Decree.

Any modification of the conditions under which an operating licence was granted must be previously authorized by the body that granted it (AEMPS or the region); any change of the data communicated to the Registro de comercialización, including cessation of commercialization, must be communicated to the register.

Any change in product name, product specifications, packaging, indications, contents of product label, package insert or product literature, or any relevant particulars of a registered product must not be made without prior approval of the Authority; registration may be cancelled for unapproved changes, and any change affecting quality, safety and efficacy requires a new registration application.

Registered actors must keep their registered contact and invoicing data current; changes (only the changed data plus basic identification) and deregistrations are filed by the actor itself via Läkemedelsverket's e service, one registration per role. Product data for NMI and Art. 16.2 16.4 activities can be changed, newly registered and deregistered within a role.

Changes to registered actor data must be reported to Swissmedic by the economic operator concerned within one week.

outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: Registered actor data changes are notified within one week (Art. 55(2) MedDO); device data updates in swissdamed are free of charge (administrative update); changes affecting the device or mandate follow the EU change regime (Art. 12 EU MDR via Art. 51(4) MedDO), with certificate supplements where required (Art. 26(3)); re registration of a 'discarded' device in swissdamed is a new, fee bearing registration.

the swissdamed registration obligation itself becomes due for devices on the market (including legacy devices under Art. 101 MedDO) when it enters into force on 1 July 2026; each device is invoiced once, in the year of its initial registration; from 1 January 2027 only new registrations are invoiced; new registration of a device previously marked 'discarded' is a new, fee bearing registration; from 1 January 2027 only notifications of individual devices may be submitted (custom made devices under Art. 19 MedDO excepted)

Changes to items designated by the central authority require prior approval (Act Art. 26). The licence regulation lists ten approval required change items: Chinese product name; English product name; original label, IFU or packaging; composition, materials, structure, specification or model; efficacy, use or indication; manufacturer name; manufacturer address or country of manufacture; licence owner (transfer); licence owner name; and manufacturing permit number. Replacing lost/damaged licences or approved label documents also requires application.

Minor label/packaging changes need no prior approval: (a) changes that do not alter the approved text (materials/graphics, proportional resizing, font changes, adding printed outer boxes), and (b) enumerated text changes such as adding or changing barcodes, recycling marks, CE marks, suggested retail prices, or distributor name/address; the holder makes the change and keeps a change record.

After market authorization, all changes made to the product must be reported to TMDA; the MAH must submit applications for changes and provide scientific evidence that the changes do not negatively affect quality, safety or performance, per the Guidelines on Submission of Applications for Changes to Approved Medical Devices and In vitro Diagnostics (TMDA/DMD/MDA/G/003).

Where information already notified (จดแจ้อยู่) changes, the notifier must report the changed information to the licensing authority, following criteria, methods and conditions set by the authority.

applicationFormat: Full CSDT · additionalDocuments: declaration of identicality; letter of consent; safety declaration

masterRegistrationCancelledAfterApproval: Yes · formerHolderClosureDeadlineDays: 30

A change disqualifies a product from the light administrative AMC track and sends it to control by the ANMPS technical services at the next importation, until a satisfactory evaluation report or a compliant analysis report is obtained. The disqualifying changes are a modification concerning: the composition of the products (ingredients, formulation or materials); the manufacturing processes; the certifications (change of, or acquisition of a new, conformity certificate) or technical analyses; or the packaging, labelling and instructions for use. The other disqualifiers are: a non compliance during previous importations in the preceding two years; an AMC granted subject to an undertaking requiring verification by the ANMPS technical service; a serious vigilance incident internationally; a pending complaint from users or consumers in Tunisia; or a pending request for further information by letter on a lot filed during a previous importation.

Where a manufacturer terminates a notified body contract and contracts another notified body for conformity assessment, detailed arrangements for the change must be clearly defined in an agreement between manufacturer, new notified body and (where applicable) previous notified body, covering at minimum certificate invalidity date, use of the previous NB identification number, document transfer (including confidentiality/ownership), handover date of tasks, and the last serial/lot number covered by the previous body.

Where a manufacturer (other than for custom made devices) foresees an interruption or cessation of supply of a device, other than for reasons of bankruptcy, that could result in serious harm or a serious risk to patients or public health in Turkey or one or more EU member states, it must inform the Kurum without undue delay (article added by RG 17/8/2024 32635).

Whenever a holder of a certificate of registration wishes to make an amendment or alteration to the particulars provided in the application for registration, the holder must apply to the Authority for amendment or alteration of the registration (reg. 39(1)). The application must be accompanied by a detailed description of the amendment or alteration to be effected with reasons for it, where applicable samples of the altered product, and the prescribed fee (reg. 39(2)). DAR/GDL/028 s. 4.10 requires the application for variation of a registered surgical instrument or appliance to be made using Appendix V, and requires the National Drug Authority to be informed of any significant change — a 'significant change' being defined in reg. 24 as a change that could reasonably be expected to affect the safety or effectiveness of a surgical instrument. NDA's Medical Devices page states the same duty for registered devices generally: inform NDA of any changes to a registered medical device currently through a Variation application.

Changes to an approved device design that may affect compliance with the technical regulation or the conditions of use of the certificate must be separately approved by the body that issued the design examination certificate; the approval is issued as a supplement to the certificate.

The manufacturer must inform the designated body in advance of any planned significant changes to the quality management system; the body evaluates the changes and sends a reasoned decision.

outcomes: prior approval amendment or variation; new registration or new application · description: Minor changes (e.g. leaflet, manufacturing location, Marketing Rights holder change) are handled by a minor change/amendment request without a new application; EDE's amendment service accepts minor variation requests only while the marketing authorization is valid or an active renewal application exists.

fundamental changes in medical device design (Art. 15(5)); substantial changes in composition or formulation; significant changes in dosage form or concentration; changes in product classification or route of administration not covered by the current approval; significant manufacturing process changes affecting quality, safety or effectiveness; voluntary market withdrawal for later re introduction with significant changes; pharmacovigilance findings requiring withdrawal or re assessment and significant changes to the product

Ownership of a marketing approval may be transferred to another party with EDE approval; import/export permit ownership is not transferable when the importing or exporting establishment changes, a new permit must be applied for.

A new registration (potentially with statutory fee) is required for: adding devices in GMDN categories not already on the account; changing device characteristics (wrong GMDN, class, sterile/non sterile, brand name the device must be re registered); changing an IVD's status (e.g. performance evaluation to new); changing device legislation (e.g. MDD to UK MDR 2002 fee waived if the GMDN category is unchanged); change of UK Responsible Person; and adding represented manufacturers.

For changes to a 510(k) cleared device there is no supplement mechanism: the outcomes are either internal documentation under the manufacturer's change control procedures (when 21 CFR 807.81(a)(3) is not triggered) or submission of a new 510(k); PMA side changes instead use the supplement regime of 21 CFR 814.39.

A new 510(k) is required for (i) a change or modification in the device that could significantly affect the safety or effectiveness and (ii) a major change or switch in the device's intended use (21 CFR 807.81(a)(3)(i) (ii)); PMA changes are handled through the supplement regime of 21 CFR 814.39 or periodic reports where no supplement is required.

PMA changes follow 21 CFR 814.39: a supplement is required for changes affecting safety or effectiveness (indications, labeling, manufacturing facilities/methods, design, etc.); qualifying changes may use 30 day supplements or 'changes being effected' supplements; certain manufacturing changes may proceed on a 30 day notice (distribution 30 days after FDA receives the notice unless FDA objects, and inadequate notices become 135 day supplements); changes with no safety/effectiveness impact may be documented in periodic reports, and changes under an FDA approved Predetermined Change Control Plan (FD&C 515C) require no supplement.

Product registrations included in a certificate may be transferred to another company (Cesión de Registro) only with prior approval of the Departamento de Tecnología Médica; the transfer is definitive and keeps the validity of the original registration.

Any modification made by the manufacturer or importer must be communicated to the competent sanitary authority for the purpose of updating the registration; failure to comply with this duty is a ground for suspension of the product registration.

Where information in the registration documents changes during the certificate's validity or extension, the applicant must submit a change application through the information system with documents, samples and standards as needed; the Centre refuses changes that may negatively affect the device's quality, efficacy or safety. A fee for change applications is levied in MoH approved amounts based on the Centre's costs. Change applications are reviewed within periods not exceeding 50 percent of the registration timelines (recognition route registrations exempt).

Dossier information changes are handled by notification on dedicated forms: Mẫu 12 (production conditions dossier), Mẫu 13 (Class A/B declaration dossier), Mẫu 14 (Class C/D registration dossier) — confirming notification type change control outcomes.

statement: Changes to a granted marketing authorisation are made by way of an amendment application, and ZAMRA's fee schedule distinguishes a minor amendment (US$100 for an imported allied substance) from a major amendment (US$500). The IVD guideline provides a distinct application for amendment of an IVD device with marketing authorisation. The non IVD guideline requires the applicant to remain responsible for the product information supporting the application 'and variations thereof'. Where an applicant fails to supply additional information within the stipulated time, the IVD application is closed and must be resubmitted as a new application.

statement: Every person must inform the Authority without delay of any alteration from the information or particulars furnished in applying for approval of a type and brand of condom, and the same duty applies to a type of glove. The 2014 amendments add a package amendment fee of US$50 in each instrument, which is the published change control charge for a packaging change. Beyond the notification duty and the package amendment fee, the device instruments set out no variation categories, no prior approval requirement for changes and no substantial change test.