November Newsletter

November Newsletter

EUROPE

EUDAMED Notified Bodies and Certificates Module – Relevant documents and information| 15 November 2021

Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified Bodies (NB) should register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn or refused and other restrictions imposed on these certificates. Such information is accessible to the public.

The European Commission is not in a position to require the use of the NBs & Certificates module until EUDAMED is fully functional according to the Medical Device Regulation.

Therefore, in EUDAMED, NBs can register certificates and Summaries of Safety and Clinical Performance (SSCP) only on voluntary basis if all the parties referenced in the certificates are first registered, also on a voluntary basis, in this database. The parties to be registered would include the manufacturer, the authorised representative (where applicable), and/or the system procedure pack producer and the Basic UDI-DI(s) referenced. However, additional national requirements cannot be excluded.

EUDAMED UDI/Devices registration module – Relevant documents and information| 8 November 2021

Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce an EU device identification system based on a unique device identifier (UDI) allowing easier traceability of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market. Manufacturers can already enter UDI/Device information in the system on a voluntary basis.

The European Commission is not in a position to require the use of the UDI/Devices registration module until EUDAMED is fully functional according to the Medical Device Regulation. Therefore, additional national requirements on registrations cannot be excluded.

Guidance on labelling requirement for Medical Devices| November 2021

The Medical Devices Regulation 2017/745/EU (‘MDR’) has new requirements that ask for various kinds of information to be indicated on the label of medical devices. Originally, the present guidance was developed to support compliance with labelling requirements of the MDR in a harmonised manner before the publication of ISO 15223-1: 2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements, which has now been published (July 2021). Therefore, the present guidance has been updated to align with the new ISO 15223-1:2021.

BELGIUM

Deadlines for the submission of dossiers during end-of-year period | 10 November 2021

During the end-of-year period, the FAMHP will be closed from Monday 27 December 2021 through Friday 31 December 2021. Deadlines have been set for the submission of different types of dossiers. Dossiers for the Research and Development Division (human use) Tuesday 14 December 2021 is the final date to submit the following dossiers:
• initial applications for phase I monocentric Directive CTA dossiers;
• substantial amendments for phase I monocentric Directive CTA dossiers;
• substantial modifications for phase I monocentric CTR pilot dossiers.

FINLAND

Supervision of devices referred to in Annex XVI of the Medical Device Regulation to begin in autumn 2022 | 2 November 2021

The requirements applying to the devices referred to in Annex XVI of the Medical Device Regulation are due to enter into force in autumn 2022. The decisions issued by the European Commission will affect the timetable. According to current information, the common specifications related to the supervision of the devices referred to in Annex XVI will be completed in the European Commission in early 2022. The transition period for organising the supervision is six months from the publication of the common specifications.

Operators affected by this must follow the information communicated by the Commission and Fimea.

In Finland, Fimea is the supervisory authority for the devices listed in Annex XVI of the Regulation. In addition, new national legislation will supplement the Regulation.

SLOVENIA

Procedure for entering a test intended for self-testing in the central database of medicinal products (CBZ) | 24 November 2021

Only tests intended by the manufacturer for end users, non-experts for self-testing, are intended for registration in the CBZ. For such tests, the mandatory certification process involves a notified body established in the EU that is accredited for certification under Directive 98/79 / EC or Regulation (EU) 2017/746. In the case of a successful conformity assessment procedure, such tests shall be accompanied , in addition to the EC declaration of conformity, by the CE certificate of the notified body . In addition to the CE marking, the test also includes the four-digit number of the notified body that carried out the assessment. The enrolment process is carried out by submitting documentation to the Ministry of Health. The documentation must contain:
• EC declaration of conformity indicating that the test is intended for self-testing (risk class: IVD – self-testing, indicating the number of the CE certificate)
• CE certificate from a notified body established in the EU (with reference to Directive 98/79 / EC or Regulation (EU) 2017/746)
• Original instructions for use
• Instructions for use in the Slovenian language – please note that the translation must be the same as the original instructions with all references
• If the translation of the instructions into Slovenian is performed by your company, provide a written authorization from the manufacturer , in which he expressly authorizes you to translate the instructions into Slovenian and undertakes to inform you of any changes and new editions of the instructions for use. If you have all the above documentation, send it to the general address of the Ministry of Health.

Information on Rapid Antigen Tests that determine the presence of SARS-COV-2 Antigen| 12 November 2021

While increasing the use of rapid antigen tests that detect the presence of SARS-CoV-2 antigen, JAZMP wishes to warn consumers and other test users to be careful when selecting a test that the test is compliant with the legislation and suitable for use in the target user group. On the market, among the products offered to consumers, we also perceive tests that are intended only for use by professional users, accredited laboratories and qualified staff (“Professional Use Only”). Such tests are not suitable for self-testing, as the use of a non-compliant test or a test that is not certified for use by non-experts may lead to an erroneous test result.

Safety Notices for Medical devices| 12 November 2021

The notifications on safety corrective measures for medical devices received by JAZMP from manufacturers or authorized manufacturers’ representatives in October 2021 are available on the JAZMP website. They are available at the following Link.

ITALY

Medical devices, indications relating to the application of Regulation(EU) 2017/745 | 17 November 2021

The General Directorate of Medical Devices and Pharmaceutical Service of the Ministry of Health clarifies, with the Circular of 12 November 2021, some aspects necessary for the application of Regulation (EU) 2017/745. 

The indications concern the provisions on the national database, manufacturers of custom-made devices , legacy devices , notified bodies, advertising, the use of harmonized standards, the products of Annex XVI of Regulation (EU) 2017/745 , tariffs and penalties.

The Circular has the purpose of guaranteeing a uniform and consistent application of the Regulation until the full functioning of Eudamed and during the period of validity of the CE markings pursuant to the directives.

GERMANY

Current Processing Statistics of the Federal Institute for Drugs and Medical devices | 17 November 2021

Processing Statistics: Applications for Authorization and Registration

Current Processing Statistics of the BfArM

SAE Report | 11 November 2021

From the date of application of the Regulation (EU) 2017/745 (MDR) on May 26, 2021, the reporting of serious adverse events (SAEs) and device deficiencies must be carried out in accordance with the MDR in conjunction with the Medical Device Law Implementing Act (“Medizinprodukterecht-Durchführungsgesetz”, MPDG) for all clinical investigations that must be applied for or notified to the federal higher authority (“Bundesoberbehörde”).

This also applies to already initiated (ongoing) clinical investigations for which SAEs were previously to be reported to the higher federal authority in accordance with the MPSV.

IRELAND

In-house manufacturing of in-vitro diagnostic medical devices – stakeholder survey | 22 November 2021

The HPRA have published a survey to collect information about how in-house manufacturing of in vitro diagnostic medical devices will be impacted by the In Vitro Diagnostics Regulation (IVDR). We invite medical laboratory scientists and personnel who work with in vitro diagnostic medical devices to complete the survey, which is available at this link: HPRA IVD In-house Manufacturing Survey.

This survey is a follow-up to a preliminary survey conducted by the HPRA in 2020 to gather information on devices manufactured, modified and used only within health institutions, known as ‘in-house devices’. The information collected will be used to assist in the implementation of IVDR.

Applying for a certificate of free sale | 4 November 2021

The HPRA has published updated information relating to export certification, including information about applying for a certificate of free sale for medical devices.
In this update, the HPRA has:
• Provided an overview of the legal basis for issuing certificates of free sale;
• Clarified the process for applying for certificates of free sale under Directive 93/42/EEC (MDD) and Regulation 2017/745 (MDR);
• Developed a checklist to assist stakeholders when applying for a certificate of free sale.

SWITZERLAND

Procurement of medical devices in healthcare institutions| 15 November 2021

Swissmedic recommends that health institutions include a check for conformity with the relevant regulatory requirements during the procurement process for medical devices and that they check and keep the documentation on product conformity (declaration of conformity and EC certificates) to be checked and stored.

Information and help on the procurement of medical devices in health institutions:

Procurement of medical devices in healthcare institution

UK 

Notify the MHRA about a clinical investigation for a medical device |16 November 2021

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.

If possible, please provide the MHRA with advanced notice of your intention to submit a clinical investigation by emailing [email protected] with some basic details about the investigational device, the intended population, the type of study, and estimated application date. Please provide as much notice as possible. An advanced notice is helpful to the MHRA, however is not a substitute for the formal clinical investigation notification.

USA

Webinar on 14 December 2021 on Final Rule for Medical Device De Novo Classification | 24 November 2021 

On Tuesday, December 14, 2021, at 1:00 pm ET, the U.S. Food and Drug Administration (FDA), will host a webinar for stakeholders interested in learning about the final rule, Medical Device De Novo Classification Process, and associated guidance document updates. This final rule describes the FDA’s De Novo classification process that provides a pathway for certain novel medical devices to be classified as class I or class II, rather than automatically as a class III device, which requires premarket approval (PMA).

Federal Register: General and Plastic Surgery Devices; Classification of the General Laparoscopic Power Morcellation Containment System | 22 November 2021 

The Food and Drug Administration (FDA or we) is classifying the general laparoscopic power morcellation containment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the general laparoscopic power morcellation containment system’s classification. They are taking this action because they have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device.

Reclassification | 19 November 2021

The FDA generally classifies medical devices based on the risks associated with the device and by evaluating the amount of regulation that provides a reasonable assurance of the device’s safety and effectiveness. Devices are classified into one of three regulatory classes: class I, class II, or class III. The regulatory class of a device type, as defined in Section 513(a) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(a)) and its implementing regulation at 21 CFR 860.3, may be changed through the process of reclassification. The main purpose of reclassification is to apply the appropriate level of regulatory controls for a device type based on the most current information regarding its safety and effectiveness. Reclassification is applied to a device type and not an individual device.


The sections of the FD&C Act that address device reclassification are:
• Section 513(e) – Applies to classified devices, except those devices currently classified into class III under Section 513(f)(1).
• Section 513(f)(3) – Applies to post amendments devices classified automatically into class III under Section 513(f)(1).

FDA in Brief: FDA Issues Final Orders Reclassifying Certain Hepatitis C Diagnostic Tests from Class III to Class II | 19 November 2021

The FDA issued two final orders, reclassifying certain HCV diagnostic tests from class III to II. These orders allow these HCV tests to use FDA’s 510(k) pathway rather than the PMA pathway.

The two types of HCV diagnostic tests being reclassified are nucleic acid-based HCV ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA and certain HCV antibody devices intended for the qualitative detection of HCV.

Federal Register: Effective Date of Requirement for Premarket Approval for Blood Lancets | 19 November 2021

The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III.

Federal Register: General and Plastic Surgery Devices; Reclassification of Blood Lancets | 19 November 2021 

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class II (special controls) and subject to premarket notification, specifically, single use only blood lancets with an integral sharps injury prevention feature, single use only blood lancets without an integral sharps injury prevention feature, and multiple use blood lancets for single patient use only. FDA is designating special controls for these three types of blood lancets based on the determination that general controls only are not sufficient and there is sufficient information to establish special controls to provide a reasonable assurance of their safety and effectiveness. FDA is also reclassifying a fourth type of blood lancet, multiple use blood lancets for multiple patient use, from class I (general controls) exempt from premarket notification into class III (premarket approval). FDA is reclassifying these four types of blood lancets on its own initiative based on new information.

Federal Register: Reclassification of Certain Hepatitis C Virus Antibody Assay Devices, Renamed to Hepatitis C Virus Antibody Tests| 19 November 2021

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, post amendments class III devices (product code MZO) into class II (general controls and special controls), subject to premarket notification. FDA is renaming and codifying these devices under the classification regulation named “hepatitis C virus (HCV) antibody tests.” FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices.

Federal Register: Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, Renamed to Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests| 19 November 2021

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, post amendments class III devices (product codes MZP and OBF), into class II (general controls and special controls), subject to premarket notification. FDA is renaming and codifying these devices under the classification regulation named “nucleic acid-based hepatitis C virus (HCV) ribonucleic acid tests.” FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices.

Federal Register: Administrative Detention and Banned Medical Devices| 19 November 2021

The Food and Drug Administration (FDA or the Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection for administrative detention and banned medical devices.

21 CFR sectionNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
Administrative detention reporting requirements—800.55(g) and (h)  1  1  1  25  25
Banned devices reporting requirements—895.21(d)(8) and 895.22(a)  26  1  26  16  416
Total    441

Table 1—Estimated Annual Reporting Burden

21 CFR sectionNumber of recordkeepersNumber of records per recordkeeperTotal annual recordsAverage burden per recordkeepingTotal hours
Records regarding device adulteration or misbranding and records of distribution of detained devices—800.55(k)1112020

Table 2—Estimated Annual Recordkeeping Burden

Medical Device Development Tools (MDDT) | 16 November 2021

The FDA has qualified MDDTs for cardiovascular, neurology, plastic surgery, automated insulin dosing, and imaging devices, as well as crosscutting tools for active implanted medical devices and cybersecurity.
The following table lists MDDTs qualified by the FDA, along with a Summary of Evidence and Basis of Qualification (SEBQ) for the tool. This summary includes:
• A brief description of the tool
• The qualified context of use
• A general summary of evidence to support qualification
• A brief assessment of the advantages and disadvantages of using the tool
• Information on how to contact the tool developer about accessing the tool
Medical device sponsors submitting a marketing application that relies on a qualified MDDT may include the MDDT submission number in the cover letter or the FDA CDRH Premarket Review Submission Cover Sheet form 3514 (Section F or J). The MDDT submission number for each qualified tool can be found in the SEBQ.

Federal Register: Content of Premarket Submissions for Device Software Functions | 3 November 2021

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Content of Premarket Submissions for Device Software Functions.” This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are functions that meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act). When final, this document will replace FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” issued on May 11, 2005, and it will update FDA’s thinking related to the documentation FDA recommends sponsors include for the review of device software functions in premarket submissions. This draft guidance is not final nor is it in effect at this time.

BRAZIL

Anvisa informs the end of the rule on the import of medicines and medical devices | 18 November 2021

ANVISA informs that the Resolution of the Collegiate Board (RDC) 483/2021, on requirements for the importation of new medical devices and drugs identified as priority for use in health services, has not been extended, as informed at the Public Ordinary Meeting 22, of 10 November 2021.

The norm lost its effects on November 13th. The resolution was issued on an exceptional and temporary basis in March 2021, due to a critical moment of the Covid-19 pandemic in the country. At that time, there was a vertiginous increase in the number of people hospitalized in intensive care units (ICUs), with a consequent shortage of drugs in the Brazilian market, especially those used for sedation and anaesthesia for orotracheal intubation.

Contribute to the Design Control Guide for Medical device Manufacturers | 18 November 2021

ANVISA announces that the  first version of the Guide for Project Control for Manufacturers of Medical Devices is available . Those interested in contributing to the improvement of the publication may submit their suggestions until January 24, 2022, using an  electronic form.        

The guide is an adapted and edited translation of the IMDRF GHTF SG3 Design Controls Guidance for Medical Devices Manufacturers document. Your goal is to help manufacturers of medical devices to understand the d system requirements and quality for the control and development of projects recommended by the   Board Resolution (RDC) 16/2013 , through the interpretation of terminology and the explanation of regulatory concepts in practical terms for implementation in your Quality Management System.

AUSTRALIA

Frequently Asked Questions (FAQs) on reclassification of medical devices | 22 November 2021 

Reclassification of medical devices frequently asked questions.

Link : https://www.tga.gov.au/frequently-asked-questions-faqs-reclassification-medical-devices

Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous system | 22 November 2021 

This guidance aims to assist sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021, medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS)will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.

Reclassification of medical devices that administer medicines or biologicals by inhalation | 22 November 2021 

This guidance aims to assist sponsors of medical devices that administer medicines or biologicals by inhalation with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021, medical devices that administer medicines or biologicals by inhalation will be required to meet regulatory requirements demonstrating the safety and efficacy of the product commensurate with the higher classification (Class IIa or Class IIb).

Reclassification of medical devices that are substances introduced into the human body via a body orifice or applied to the skin | 22 November 2021 

The purpose of this guidance is to assist sponsors of medical devices that are substances for introduction into the body with meeting their obligations and outlines transitional arrangements to help comply with new regulations. From 25 November 2021, some medical devices that are substances for introduction into the body will be required to be reclassified. The new regulatory requirements will also include:
• more detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device
• conformity assessment documents demonstrating procedures appropriate for their classification
• a mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence.

Reclassification of spinal implantable medical devices | 22 November 2021 

The purpose of this guidance is to assist sponsors and manufacturers of spinal implantable medical devices to understand and comply with new regulatory requirements. From 25 November 2021, some spinal implantable medical devices will be required to be reclassified. The new regulatory requirements will also include:
• more detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device
• conformity assessment documents demonstrating procedures appropriate for their classification
• a mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence.

Consent for Non-compliant Medical Device(s) – Frequently Asked Questions | 22 November 2021 

Consent to import, supply or export a medical device that does not comply with the Essential Principles – frequently asked questions.

Link: https://www.tga.gov.au/consent-non-compliant-medical-devices-frequently-asked-questions

Consent to supply medical devices that are non-complaint with the Essential Principles (EPs) | 18 November 2021

If you are a sponsor and supply a medical device that has become non-compliant with the EPs you will need TGA approval to continue to supply them. You will need to use the Consent to Supply application form. The TGA is currently modernising the Consent to Supply application process, moving from a paper form to an online form in two phases, with Phase 1 -Interim online form on the TGA Consultation Hub, completed earlier this year. Phase 2 of the project is now ready for release with the online form moving to the TGA Electronic Business Services (tBS) portal with additional functionality including the ability for sponsors to view their current and previous applications.

Medical Device Incident Reporting (MDIR) guide | 12 November 2021

This document is a user guide for sponsors in regard to the MDIR system. It outlines the initial steps to access the MDIR system and then describes how to use the system, with step by step instructions and examples as required. The MDIR system has been enhanced to enable sponsors and manufacturers to monitor and track device incident reports. You will be able to lodge reports electronically, update previously reported incidents with additional information, review the status of reports, update initial and follow-up reports, and view past reports. All submitted reports and updates are received immediately by the Therapeutic Goods Administration (TGA).

Adverse Event reporting | 12 November 2021 

The primary function of post market event monitoring is to improve the health and safety of patients, health care professional, users, and others by reducing the likelihood of adverse events being repeated. Adverse event reporting allows the TGA to monitor medical device use, monitor their performance in the real world and identify trends that may indicate emerging safety and performance issues. These activities allow the TGA to take appropriate regulatory action to address these issues, thereby reducing the impact on the public.

It is an automatic condition of inclusion under 5.7 of the Therapeutic Goods (Medical Devices) Regulations 2002 that sponsors of a medical device report adverse events or near adverse events to the TGA Incident Reporting and Investigation Scheme (IRIS).

Medical devices reforms: Personalised Medical Devices| 5 November 2021

Prior to 25 February 2021, most personalised medical devices (PMD) met the definition of ‘custom-made’ and were exempt from the requirement to be approved by the TGA and included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported or supplied (though they were subject to other regulatory obligations).

Following extensive consultation and liaison with other global regulators, the Therapeutic Goods Administration (TGA) developed a new regulatory framework for PMD. This new framework has been introduced by the Government to ensure an appropriate level of regulation is applied to PMD in order to manage the risk they may pose.

Custom-made medical devices | 4 November 2021

If a device you manufacture or import is impacted by this change and requires inclusion on the ARTG, there are transition arrangements in place until 1 November 2024 to allow you to complete this process.

RUSSIA

On November 15, the I All-Russian Forum with international participation “Circulation of medical devices NOVAMED-2021” began work in Moscow| 15 November 2021 

On November 15, a two-day All-Russian Forum with international participation “Circulation of medical devices” NOVAMED-2021 “, organized by Roszdravnadzor, the Ministry of Health of Russia and the Ministry of Industry and Trade of the Russian Federation, opened in Moscow.

More than 600 delegates from Japan, Brazil, Australia, Kyrgyzstan, Belarus, Kazakhstan and 85 constituent entities of the Russian Federation took part in the event in person and remotely.

At the end of the plenary session, the results of the competition “Safety of medical devices – for the benefit of people” were summed up, organized by the Federal State Budgetary Institution “National Institute of Quality” of Roszdravnadzor.

CHINA

Updated on the development of therapeutics, vaccines, medical devices and test kits | 24 November 2021

The Ministry of Health, Labor and Welfare conducts prioritized and prompt examinations of new coronavirus-related drugs, medical devices (ventilators, etc.) and test kits.

Approval information for medical devices for new coronavirus infections
Approval information for in-vitro diagnostic drugs (test kits) for new coronavirus infections

VIETNAM

New Regulations on Medical Device Management in Vietnam| 25 November 2021

On November 8, 2021, the Vietnamese government issued Decree No. 98/2021/ND-CP on the Management of Medical Devices (“Decree 98”). The new decree will take effect from January 1, 2022, replacing Decree No. 36/2016/ND-CP and its amendments on the same subject (“Decree 36”).

  • Classification of Medical Devices

Under Decree 98, responsibility for the classification of medical devices is given to the organization registering or declaring the medical device. Under Decree 36, this responsibility was reserved for Vietnamese organizations qualified for medical device classification.

  • Clinical Trials of Medical Devices

Decree 98 provides stricter and more detailed requirements on clinical trials. Particularly, medical device trials will include three phases, in which phases 1 and 2 need to be finished before the product registration, while phase 3 will be conducted after the medical devices are approved for circulation, following the specific requirement from the authorities. This requirement aims to continue evaluating the safety and efficacy of medical devices after they are widely used in the community in line with their usage conditions.

  • Medical Device Registration

Similar to the current regulations, Decree 98 requires that medical devices must be registered with the Vietnamese authority (i.e., must obtain registration numbers) before being imported/manufactured for circulation in the Vietnam market. However, Decree 98 further stipulates new requirements.

  • Price Management

In an effort to control the price of medical devices, Decree 98 includes a new requirement in which registration number holders must declare the prices of their medical devices on the Portal of Medical Device Management before putting the medical devices on the Vietnam market; the actual prices must not be higher than the declared prices.

  • Importation of Medical Devices

Decree 98 sets out situations where medical devices without registration numbers must have import licenses. These include, among others, medical devices for scientific research, tests, trials, quality assessment, or training; medical devices for aid, humanitarian aid, gifts, fairs, exhibitions, displays, or product introduction; and medical devices meeting urgent needs for national defence, security, epidemic prevention and control, and overcoming consequences of natural disasters and catastrophes. 

  • Medical Device Advertisement

Decree 98 completely removes the procedure for approval of medical device advertising contents. Instead, the holders of medical device registration numbers or their authorized entities will be responsible for publicly declaring the intended content and form of the advertising on the Portal of Medical Device Management before conducting the advertising.

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