USA (FDA)

EUROPE

Czech Republic (NISZP)

Manufacturers in third countries wishing to place devices on the EU market should familiarise themselves with the rules, timelines and obligations applicable under the Regulations.

As an authority in a third country that imports devices from the EU, you need to know about the timelines for implementing the Regulations. Please also bear in mind that during the transition periods, devices that are compliant with the previously applicable Directives and devices that are compliant with the current Regulations co-exist and may simultaneously be placed or made available on the EU market. This is of particular importance for those third countries that rely on the CE marking of devices to grant access to their markets.

Latvia (ZVA)

The State Medicines Agency informs that today, on August 23, 2023, the Cabinet of Ministers Regulation No. 461 of August 15, 2023 ” Medical Device Regulations ” came into force.

The new regulations on medical devices have been adopted to implement the obligations arising from the norms of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (hereinafter – Regulation 2017/745).

With the entry into force of these regulations, the regulations of the Cabinet of Ministers of November 28, 2017 No. 689 “Procedures for registration, conformity assessment, distribution, operation and technical supervision of medical devices”.

New Rules for Clinical and In Vitro Diagnostic Performance Studies of Medical Devices Come Into Force

The State Medicines Agency informs that today, on August 23, 2023, the Cabinet of Ministers’ regulations of August 15, 2023 No. 455 ” Procedure for conducting clinical studies of medical devices intended for humans and performance studies of in vitro diagnostic medical devices “.

The new regulations have been adopted to implement Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (hereinafter – Regulation 2017/745) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (hereinafter – Regulation 2017/ 746) obligations resulting from norms in the field of clinical trials and performance studies.

With the entry into force of the new regulations, the regulations of the Cabinet of Ministers of September 21, 2010 No. 891 “Procedures for clinical research of medical devices intended for humans”.

Poland (URPL)

According to Art. 16 section 1 point 3 of the Act on Medical Devices, which implements the provisions of Regulation (EU) 2017/746, it is prohibited to supply and make available to a lay person, for self-use, an in vitro diagnostic medical device other than a self-testing device, a sample container or a general laboratory product, and for breaking this prohibition there is a fine of up to PLN 250,000, as referred to in Art. 98 of this Act.

Self-testing devices shall be designed and manufactured in such a way as to ensure ease of use in the home environment by the layman and to minimize the possibility of user error in handling the self-testing device and in interpreting the results. The conformity assessment of self-testing products requires the appropriate participation of a notified body. This body issues an appropriate certificate of conformity, and in the marking and instructions for use of such a product, the identification number of this body is placed next to the CE mark. The product labeling also includes information that the product is a self-monitoring device.

Recognizing the nature and importance of the above-mentioned problem, the President of the Office informs that it is permitted to provide and make available to persons who are not professional users (laymen) only tests intended for self-use (“self-testing products”) which:

• have been placed on the market as self-testing devices and have a certificate issued by a notified body (i.e. they have been verified by an independent institution),
• have the number of the notified body that certified this test next to the CE mark,
• have packaging (labels), instructions for use and a user interface in Polish, and
• have a clear wording on the packaging (label) and in the instructions for use that they are intended for self-testing.

Slovakia (SUKL)

On the basis of §129 paragraph 2, letter j) of Act 362/2011 Coll. on medicines and medical devices in the version effective from 1 August 2023 (amendment 293/2023 Coll.), ŠÚKL is again authorized to issue free sale certificates (FSC) for manufacturers/authorized representatives (EC-REP based in the Slovak Republic) for medical devices /diagnostic medical devices in vitro.

Amendment to the act on Medicines and Medical Devices and on Amendments and Supplements to Certain Acts 362/2011 Coll., temporary version valid from 1 August 2023

Requirements for testing medicines, medical devices and diagnostic medical devices in vitro, including ethical assessment by the ethics committee of human medicine, for clinical testing of medical devices and for studying the performance of diagnostic medical devices in vitro (hereinafter referred to as the “ethics committee”),

Unauthorized treatment of medicines and medical devices is treatment of medicines and medical devices in a way other than that established by this law or a special regulation. Unauthorized handling of medicines and medical devices is not the handling of medicines or medical devices, including in vitro diagnostic medical devices, by the Ministry of Health of the Slovak Republic (hereinafter referred to as the “Ministry of Health”), if these medicines or medical devices were procured or acquired by the Ministry of Health in a different way than procurement during a declared state of emergency, state of emergency or extraordinary situation (hereinafter referred to as “crisis situation”) or are the subject of contractual relations concluded by the Ministry of Health during a crisis situation; the Ministry of Health shall ensure the storage, delivery and dispensing of human medicines and medical devices through the holder of a permit for handling medicines and medical devices according to this Act.

Placing a medical device on the market is the first making a medical device available to another person for a fee or free of charge for the purpose of distribution or use on the market of the Member States, except for use for the purpose of a clinical trial, regardless of whether it is a new medical device or a renewed medical device.

Switzerland (SWISSMEDIC)

The Swissdamed application – the Swiss Database on Medical Devices – is a Swissmedic IT system that makes it possible to apply the Swiss regulations on medical devices and in vitro diagnostic medical devices.

It is structured around two interconnected modules; which only registered users can access. It also includes a freely accessible search function.

• Registration of companies and economic operators – ACT module (available early 2024)
• Swissdamed – freely accessible platform (available early 2024)
• Registration of devices – UDI module (available from summer 2024)
• The above modules will be made available in different releases.

United Kingdom (MHRA)

The Medicines and Healthcare Products Regulatory Agency (MHRA) has designated three new UK Approved Bodies, almost doubling the UK’s capacity to certify medical devices, supporting faster certification of safe and effective medical devices for healthcare professionals and the public.

Before appointing an Approved Body, the MHRA conducts a detailed assessment process to ensure that organizations are stable and able to undertake impartial and objective conformity assessment activities, that they have an appropriate quality management system, the capacity and competence to undertake assessments and the processes they use meet the relevant regulatory requirements.

After successful designation, the MHRA monitors UK approved bodies’ activities including by regular audits and by witnessing some of their audits of manufacturers.
For any organisations wanting to become an approved body, please contact [email protected].

MORE Registrations – user reference guide

A step-by-step guide on using the MORE Platform for Submissions of device related incidents.

Update

Updated Submissions guidance to reflect: Update to screenshots, guidance for draft reports and auto-population of submitter fields.

https://www.gov.uk/government/publications/more-submissions-user-reference-guide#full-publication-update-history

Notify the MHRA about a clinical investigation for a medical device

The guidance explains about How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

A notification to the MHRA will not be required for medical devices that are UKCA / CE / CE UKNI marked for the purpose that is under investigation.

Update

Added information on fees payable in relation to clinical investigation and amendments to clinical investigations

Medical devices: UK approved bodies

UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

Update

Published – Intertek Medical Notified Body UK Ltd Medical Devices Scope.

Export medical devices

Order a certificate of free sale to export medical devices outside the UK. You may need a Certificate of Free Sale (CFS) to export medical devices. To find out, check the import rules of the country you are exporting to. Talk to your importer or get help researching your export market.

The MHRA only issues a CFS as a service to UK exporters for medical devices. If you need a CFS for other products, contact the Department for Business and Trade (DBT).

Update

Updated ‘Certificates of Free Sale for Medical Devices’ reference guide.

Register medical devices to place on the market

The guidance explains how to register your medical devices with the Medicines and Healthcare Products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland.

Requirements for Great Britain-based manufacturers placing devices on the Northern Ireland market

Great Britain manufacturers must designate an Authorized Representative based in the EU or Northern Ireland in order to place a device on the Northern Ireland market.

Where an EU-based Authorized Representative is appointed, the Great Britain-based manufacturer must register all device classes other than Class I devices and general IVDs (that are not for self-testing) with the MHRA.

Where a Northern Ireland-based Authorized Representative is appointed, the Authorized Representative must register all devices with the MHRA.

Please note that new requirements have been introduced regarding the registration of custom-made devices in Northern Ireland. Please see below for further information.

Distributors and suppliers are not required to register with the MHRA.

Update

Updated – Account Management Reference Guide & Device Registration Reference Guide.

Medical devices: guidance for manufacturers on vigilance

Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.

Adverse incidents involving medical devices that occur in the UK must be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA is responsible for the UK medical device market. Once a medical device has been placed on the UK market, the manufacturer must submit vigilance reports to the MHRA when certain types of incidents that involve their device occur in the UK. The manufacturer must also take appropriate safety action when required. The manufacturer will need to ensure their device meets appropriate standards of safety and performance for as long as it is in use.

The notification and evaluation of adverse incidents and field safety corrective actions (FSCA) involving medical devices is known as the medical device vigilance system. Comprehensive information on the medical device vigilance system is given in MEDDEV 2.12/1 rev 8 and the additional guidance under ‘Post-Market Surveillance’, and describes what, how and when to report adverse incidents involving medical devices on the UK market.

Update

Guidance updated to reflect the latest information regarding the MORE portal.

CE marking recognition for medical devices and in vitro diagnostics

The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics. The extended recognition of CE marking does not apply to medical devices or IVDs. The government has already put in place legislation that amends The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) to extend the acceptance of CE marked medical devices on the Great Britain market. More specifically, legislation now enables CE marked medical devices to be placed on the Great Britain market.

• general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking
• can be placed on the Great Britain market up until the sooner of the expiry of the certificate or 30 June 2028
• in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner
  of the expiry of the certificate or 30 June 2030, and
• general medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices
  regulation (EU IVDR) can be placed on the Great Britain market up until 30 June 2030.

Ireland (HPRA)

If devices qualify under Regulation 2023/607, and you would like a certificate of free sale from the HPRA for those devices, we will request you to complete and submit our new application form together will all other required documentation. For devices that qualify under Regulation 2023/607, this will include:

• Declaration of conformity,
• Manufacturer self-declaration letter,
• Proof of payment,
• Device schedule,
• Unless otherwise stated in the declaration of conformity, a letter confirming the physical site of manufacturer.

The HPRA will introduce a three-year expiry date for such certificates from the date of issue of the certificate.

ASIA

India (CDSCO)

India’s Department of Pharmaceuticals (DoP) has released the National Policy on Research & Development and Innovation in the Pharma-Med Tech Sector in India. In the document, DoP identifies the need for a regulatory environment that “facilitates innovation and research in product development.”

Indian officials are concerned about “the relatively low pace of development of biologics, biosimilars and other emerging products/trends” and see the innovation policy as a way to “help enhance domestic availability and affordability of these categories of new age therapeutics.” The concern informed the decision to make enabling “rapid drug discovery and development and innovation in medical devices by streamlining of regulatory processes” the first objective of the policy.

DoP sees changes to the regulatory environment as a way to facilitate its other objectives. The policy names regulatory complexity as a barrier to private investment in innovation, a core goal, and discusses the need to develop a “talent ecosystem” that creates a medical device workforce that includes people with “knowledge of navigating regulatory policies.”

Malaysia (MDA)

This document applies to all home use medical devices that fall within the definition of a medical device, as defined in MDA/GD/0006: Definition of Medical Device, including in vitro diagnostic (IVD) medical devices. This guidance document specifies the criteria for the importation of personal use medical devices as defined in the Medical Device (Exemption) Order 2016.

Importation and placement of a medical device in the Malaysian market requires the medical device to comply with the requirements of the Medical Device Act 2012 (Act 737), and the medical device shall be registered with the Medical Device Authority (MDA) under Section 5 of Act 737. However, the Medical Device (Exemption) Order 2016 has provided an exemption from medical device registration and establishment license requirements for personal use medical devices. This document serves as guideline for individuals who intend to bring any medical devices into Malaysia (hereinafter referred as “import”) for the purpose of personal use.

Placement of HIV Self-Test (HIVST) Kit in Malaysia Market

World Health Organization (WHO) has introduced HIV self-testing as an approach to reach people who may not test otherwise, including people from key populations, men and young people3. HIV self-testing could be done by introducing HIV self-test (HIVST) kits in the in-vitro diagnostic market. This emerging technology could be used as an effective method for controlling HIV risk transmission, which could later help initiate the Pre-exposure prophylaxis (PrEP) programme for the high-risk infected person.

This document is written to guide the establishment on both pre-market, placement on the market and post-market requirements including requirements on registration of HIVST, licensing of establishments dealing with HIVST, product labelling, advertising and distribution and post-market surveillance and vigilance activities.

Public Comment First Edition Guidance Document: Wearable Medical Device

The guidance document to determine the wearable products that fall within the definition of medical device as stipulated in Section 2 of Medical Device Act 2012 (Act 737).

This guidance document excludes the products that are intended for general wellness and do not have medical claims.

This guidance document is applicable to the establishments that are dealing with wearable medical devices.

Announcement: Medical Device Authority (MDA) Circular Letter Number 1/2023: Permission to Place In The Market Self-Test Kits For Human Immunodeficiency Virus Disease (HIV)

The authorization of the placement of HIV self-testing kits (HIVST) in the market was approved by the MDA Members’ Meeting on the 15th. March, 2023 and its implementation is effective from the 14th. August, 2023 which is in line with the publication of Circular Letter of the Director General of Health Malaysia No. 14/2023 and the publication of the document Guidelines for the Implementation of HIV Self-Screening Tests in Malaysia by the Disease Control Division, Ministry of Health.

Guidelines by the MDA regarding the placement of HIV self-testing kits (HIVST) in the market are in the final stages of development and will be published by the 25th. August, 2023 as a reference and establishment guide for registering HIVST medical devices.

China (NMPA)

This guideline is applicable to the dental implant system retained in the oral cavity after surgery (not applicable to the customized implant system). The clinical evaluation is carried out through the clinical use data of the same variety of medical devices. According to the current “Medical Device Classification Catalog”, the classification code of this type of product is 17-08-01, and the management category is Class III.

This guideline refers to the materials used in products that need to meet the requirements of titanium and titanium alloys for surgical implants. For other metal materials, ceramic materials and other material products, or compared with domestic marketed products, they have brand-new technical characteristics (such as the use of New working principles, materials, structural design, surface properties, scope of application, etc.), when the existing data cannot prove that the product to be declared is safe and effective, the clinical trial data of the declared product needs to be submitted.

Announcement of the Center for Device Evaluation of the State Food and Drug Administration on Issuing the Guiding Principles for the Clinical Evaluation and Registration Review of the Same Variety of Positron Emission/X-ray Computed Tomography Systems (2023 No. 31)

According to the current “Medical Device Classification Catalog”, the PET/CT classification code is 06-17-02, and the management category is Class III.

For the CT part of the equipment to be evaluated, please refer to the “Guidelines for Technical Review of Clinical Evaluation of the Same Type of X-ray Computed Tomography Equipment” [2]. The clinical evaluation of the same species in the PET part of PET/MR can also refer to the PET-related chapters in this guideline.

Registration applicants need to comprehensively evaluate the functions of PET/CT hardware and software. Considering the diversity of PET/CT functions, this guideline only puts forward and standardizes the clinical evaluation requirements for the medical image quality of PET/CT.

Announcement of the Center for Device Evaluation of the State Food and Drug Administration on Issuing the Guiding Principles for the Clinical Evaluation and Registration Review of the Same Type of Medical X-ray Diagnostic Equipment (Class III) (No. 30, 2023)

In order to further standardize the management of medical X-ray diagnostic equipment (Class III), the Center for Device Evaluation of the State Food and Drug Administration organized the formulation of the “Guiding Principles for Clinical Evaluation and Registration Review of the Same Variety of Medical X-ray Diagnostic Equipment (Class III)”

This guideline is applicable to medical angiographic X-ray machines, mobile C-arm X-ray machines, fluoroscopy X-ray machines, oral and maxillofacial cone-beam computed tomography equipment, and limb cone-beam computer Tomography equipment. According to the current “Medical Device Classification Catalog”, the above product classification codes all belong to 06-01.

Among them, the mobile C-arm X-ray machine and the fluoroscopy X-ray machine have been included in the “Catalogue of Medical Devices Exempted from Clinical Evaluation (2021)” (“Catalogue” for short), and this guideline applies to the “Catalogue” “Except for the clinical evaluation of mobile C-arm X-ray machines with digital tomography functions and fluoroscopy X-ray machines of the same variety, mobile O-shaped/G-arm X-ray machines with digital tomography functions are also Clinical evaluation can be carried out with reference to the applicable requirements of this guideline.

The content of oral and maxillofacial cone beam computed tomography equipment involved in this guideline is the published “Oral and maxillofacial cone beam computed tomography equipment registration technical review guidelines”. “Oral and maxillofacial cone beam computer Revision of the relevant content of the Guiding Principles for Technical Review of Clinical Evaluation of Tomography Equipment.

Announcement of the Center for Device Evaluation of the State Food and Drug Administration on the release of guidelines for the registration and review of clinical evaluation of hemodialysis concentrates (No. 29, 2023)

This guideline is applicable to the hemodialysis concentrate used for hemodialysis or hemodiafiltration in patients with acute and chronic renal failure.

The hemodialysis concentrate is usually composed of agent A and agent B, and used in clinical use according to the ratio of agent A, agent B and dialysis water specified in the instructions. According to the current “Medical Device Classification Catalog”, the classification code of hemodialysis concentrate is 10-04-01, and the management category is Class III.

Agent A is usually an acidic hemodialysis concentrate, generally composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid (or citric acid), etc. Agent B is a bicarbonate hemodialysis concentrate, generally composed of sodium bicarbonate or sodium bicarbonate plus sodium chloride. Hemodialysis concentrates are commonly supplied as liquid or powder. The powder includes ordinary powder and online B dry powder. The former needs to be dissolved to form a concentrated solution before use, and the latter is directly dissolved on the matching dialysis machine and mixed with A agent and dialysis water to form a dialysate for use. Online B dry powder products typically contain only one ingredient, sodium bicarbonate.

Announcement of the Center for Device Evaluation of the State Food and Drug Administration on Issuing the Guiding Principles for the Registration and Review of the Clinical Evaluation of the Same Type of Electronic Endoscope (No. 35, 2023)

Electronic endoscopes have been included in the “Catalogue of Medical Devices Exempted from Clinical Evaluation (2021)” (referred to as the “Catalogue”), such as electronic upper gastrointestinal endoscopes. This guideline is formulated based on the “Technical Guidelines for Clinical Evaluation of Medical Devices” (hereinafter referred to as “General Rules”) and combined with the characteristics of electronic endoscopes.

This guideline does not apply to products such as capsule endoscopes. The clinical evaluation of ultrasound electronic endoscopes can refer to the applicable parts of this guideline, but the evaluation of ultrasound technical characteristics also needs to be considered.

The clinical evaluation method defined in this guideline is based on the framework and basis of the general principles and is based on the technical review requirements for comparison of electronic endoscopes of the same type.

Notice from the Device Review Center of the State Food and Drug Administration on the release of guiding principles for clinical evaluation registration review of soft contact lenses (No. 33, 2023)

This guideline applies to single-focus daily wear soft contact lenses (hereinafter referred to as soft contact lenses) that adopt the principle of optical correction for the purpose of correcting myopia, hyperopia and astigmatism. They can be colored or not. The common materials are hydrogel, Silicone hydrogel and other materials. The product classification code is 16-06-01, and the management category is Category III. Excludes continuous wear, bifocal, multifocal or graduated focal soft contact lenses.

Soft contact lenses belong to the third category of medical devices with high risks for clinical use mentioned in the “Technical Guidelines for Decision-making Whether to Conduct Clinical Trials of Medical Devices”.

Announcement of the State Food and Drug Administration on Adjusting Some Contents of the “Medical Device Classification Catalog” (2023 No. 101)

In order to further deepen the reform of the medical device review and approval system, based on the actual development and regulatory work of the medical device industry, and in accordance with the relevant requirements of the “Regulations on the Supervision and Administration of Medical Devices” and the “Working Procedures for Dynamic Adjustment of Medical Device Classification Catalogs”, the State Food and Drug Administration has decided to Some contents of the “Device Classification Catalog” have been adjusted.

The content of the “Medical Device Classification Catalog” involved in 58 categories of medical devices has been adjusted.

Announcement of the State Food and Drug Administration on the release of 4 information standards including the “Basic Data Set for Medical Device Registration and Filing Management”

This document specifies the data set classification, data item description, medical device registration management data subset and filing management data subset involved in medical device and in vitro diagnostic reagent registration and filing management.

This document specifies the identifier, Chinese name, short name, definition, data type, representation format, allowed value, measurement unit, version and source of data elements related to the registration and filing of medical devices (including in vitro diagnostic reagents) in drug regulatory information. This document specifies the data element value field codes for the registration and filing information of medical devices (including in vitro diagnostic reagents) in drug regulatory information. This document applies to the representation, exchange, identification and processing of information related to medical devices (including in vitro diagnostic reagents) in the field of drug supervision.

Taiwan (ROC)

The guidance explains about due to the unblocking of the epidemic, recent overseas travel is on the rise. The Food and Drug Administration (hereinafter referred to as the Food and Drug Administration) reminds that when going abroad, you should also pay attention to whether the products you buy are medical equipment, and you should abide by the relevant import regulations to avoid damaging your travel abroad. good mood.

If the public brings in or imports medical equipment from abroad, according to Article 6, Item 4 of the Specific Medical Equipment Project Approval Manufacturing and Importing Measures, when the following items are met and the specified quantity does not exceed the specified quantity, there is no need to apply to the Food and Drug Administration for project approval. Convenient customs clearance (limited to once every six months for each item):

The Food and Drug Administration also reminded that the mentioned convenient customs clearance medical equipment is for personal use only, and cannot be sold, transferred, or diverted for other uses. If there is any sales, it will violate the restrictions on the sale of Article 35, Item 2 of the Medical Equipment Management Law. According to Article 70, Item 10, a fine ranging from NT$30,000 to NT$1,000,000 shall be imposed.