Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures- Guidance for Industry and Food and Drug Administration Staff

The scope of this guidance document is limited to the tissue containment systems used during a power morcellation procedure for gynecologic use (product code PMU) classified under 21 CFR 884.4050 and for general use (product code PZQ) classified under 21 CFR 878.4825.

This guidance recommends non-clinical test methods that may help manufacturers meet the nonclinical performance data requirements identified in the special controls codified in 21 CFR 884.4050(b)(4) (for gynecologic use) and 21 CFR 878.4825(b)(4) (for general use), and also includes other non-clinical testing recommendations to support a 510(k) submission/substantial equivalence determination.

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

The purpose is to provide an overview of the mechanisms available to submitters through which they can request feedback in writing or during a meeting with the Food and Drug Administration (FDA) regarding potential or planned medical device Investigational Device Exemption (IDE) applications, Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, Evaluation of Automatic Class III Designations (De Novo requests), Premarket Notification (510(k)) Submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW), Dual 510(k) and CLIA Waiver by Application Submissions (Duals), Accessory Classification Requests, and certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) submitted to the Center for Biologics Evaluation and Research (CBER)) (specifically, INDs and BLAs for devices that are regulated as biological products under section 351 of the Public Health Service (PHS) Act).

Some other submission types are noted solely to indicate that they are tracked with a “Q” number and should be submitted following the processes for Q-Subs, while their details and processes are covered in separate guidance documents. Finally, there are other interactions with FDA that are outside the scope of the Q-Sub program.

Template for NB – Confirmation letter in the framework of Regulation (EU) 2023/607

Confirmation of the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation EU 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

This letter confirms that, NB Name, a Notified Body (NB) designated against Regulation (EU) 2017/745 (MDR) and identified by the number XXXX on NANDO, has received a formal application in accordance with Section 4.3, first subparagraph of Annex VII of MDR and has signed a written agreement in accordance with Section 4.3, second subparagraph of Annex VII of MDR with the following manufacturer.

UPDATE – MDCG 2020-3 Rev.1 – Guidance on significant changes regarding the transitional provision under Article 120 of the MDR – May 2023

This guidance document is intended to provide clarification on the concept of ‘significant changes in the design and intended purpose’ under Article 120(3c), point (b) MDR. It concerns manufacturers of legacy devices.

This guidance document does not elaborate on the process for manufacturers’ submission and notified bodies’ assessment of changes to the approved design10 or substantial changes to the approved quality system or the product-range covered.

Article 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR), last amended by Regulation (EU) 2023/607, states that devices which continue to comply with the AIMDD or MDD may be placed on the market or put into service until 31 December 2027 or 31 December 2028, as applicable, provided the conditions set out in Article 120(3c) MDR are fulfilled.

The first revision of this guidance document MDCG 2020-3 on significant changes regarding the transitional provisions under Article 120(3) MDR takes into account the experience gained with the application of the original version so far, is aligned with the equivalent guidance for IVDs, MDCG 2022-6 of May 2022 and adjusted to Regulation (EU) 2023/607.

2023/C 163/06 – Commission Guidance on the content and structure of the summary of the clinical investigation report

This document is intended to provide Commission guidance, in accordance with Article 77(6) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (hereafter: the MDR), for the content and structure of the summary of the clinical investigation report.

This guidance aims to ensure that the summary of the clinical investigation report presents information about the design, conduct, analysis and results of the clinical investigation in terms and in a format that are easily understandable to the intended user of the medical device.

According to Article 77 (5) of the MDR, the sponsor of a clinical investigation shall submit a report of the clinical investigation within one year of the end of the clinical investigation or within three months of the early termination and this report shall be accompanied by a summary. The minimum requirements of the clinical investigation report are outlined in Section 7, Chapter III of Annex XV of the MDR. Section 7, Chapter III of Annex XV of the MDR also outlines what will be covered by the summary.

New regulation on emergency notifications for medical devices

On May 16, 2023, the Medical Safety and Development Center Fimea issued a new regulation 1/2023 regarding the notification of a medical device by a professional user. At the same time, instructions have been given on the handling of a medical device that has been in a dangerous situation.

The order and instruction come into force on November 1, 2023 and are valid until further notice.

The order supplements Section 33 of the Medical Devices Act dealing with the reporting of dangerous situations. The purpose of the order is to ensure the comprehensive and uniform information content of emergency notifications, which is a prerequisite for handling hazardous situations and for storing and utilizing information from emergency notifications. In addition, the information contents described in the regulation provide manufacturers with the basic information to find out the cause of the dangerous situation.

The key change compared to the previously repealed Valvira regulation “Incident notification of health care equipment and supplies by a professional user” (Regulation 4/2010) is changing the hazard classification to match the manufacturer’s hazard classification. Another change concerns the handling of a device that was in a dangerous situation.

The EU Commission has published instructions on the content and structure of the report summary of clinical trials performed with medical devices

The goal of the EU regulation on medical devices (EU 2017/745, MD regulation) is to improve the patient safety of medical devices and to increase the transparency of information given to consumers and better management of information related to devices throughout the life cycle of the devices. As one measure promoting this goal, the EU Commission has published instructions on the content and structure of the summary of the clinical trial report on 8 May 2023 in the Official Journal of the European Union.

According to the regulation, regardless of the results of the study, the sponsor must report on the results within one year of the end of the clinical study. A report containing the exact results is sent to the member states where the research has been carried out and the summary of the report becomes public to everyone in the EUDAMED database before the device is placed on the market.

So far, the clinical trials section in the EUDAMED database is not ready, so the clients submit the report and summary to the authorities – in Finland, the Finnish Pharmaceutical Safety and Development Center Fimea.

The Act on Limiting the Use of Hazardous Substances in Electrical and Electronic Equipment also applies to medical equipment

The Act on the Restriction of the Use of Hazardous Substances in Electrical and Electronic Equipment, i.e. the RoHS Act (387/2013), also applies to medical electrical and electronic equipment. In June 2013, the RoHS Act and related regulations of the Ministry of the Environment implemented the EU’s RoHS Directive (2011/65/EU). This directive and its delegated directive (EU) 2015/863 restrict the use of certain metals, plastic softeners and flame retardants in electrical and electronic equipment. The requirements apply to all electrical and electronic devices that are not specifically limited outside the scope of application.

The purpose of the restrictions presented in the RoHS directive and the law is to limit the harmful effects of hazardous substances on people and the environment. The restrictions aim to reduce the exposure of users to dangerous substances at work and to protect health. The purpose is also to protect the environment and promote the recycling and final treatment of devices.

The AEMPS reports on the new CNCps procedure to confirm the validity of certificates issued in accordance with MDD

The Spanish Agency for Medicines and Health Products (AEMPS) informs of the new procedure established by the National Center for Certification of Health Products (CNCps) to confirm that manufacturers have a written agreement for the certification of health products according to the MDR, one of the necessary conditions to be able to continue marketing these products according to the new measures taken by the European Commission.

These standards will serve to guarantee the availability of medical devices on the market once the validity date of the CE marking certificates under which they are marketed has passed, publishing on March 20, Regulation (EU) 2023/607. This regulation extends the transitional period during which “legacy” medical devices compliant with directive 93/42/EEC (MDD) can be legally placed on the market provided certain conditions are met. To facilitate the correct interpretation of the conditions established for the extension, the question and answer guide has been published.

https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-nuevo-procedimiento-del-cncps-para-confirmar-la-validez-de-los-certificados-emitidos-conforme-a-mdd/

The AEMPS updates the list of filler implants used for plastic, reconstructive and aesthetic purposes

The Spanish Agency for Medicines and Health Products (AEMPS) has updated the list of filler implants used for plastic, reconstructive and aesthetic purposes with CE marking that are reported in the AEMPS Medical Device Marketing Register. This list is available in a new section of the AEMPS website where you can consult all the information in this regard on filler implants for plastic, reconstructive and aesthetic purposes.

Products that are used as facial fillers or in other dermal areas and that are applied by injection, needle or other application system, are considered medical devices as long as they are intended by their manufacturer for a medical purpose, such as a reconstructive purpose. , and which do not exert their main action within or on the surface of the human body by pharmacological, immunological or metabolic mechanisms, but to whose function such mechanisms may contribute.

However, filler implants for an exclusively aesthetic purpose, such as the correction of wrinkles, folds or for the augmentation of cheekbones or lips or to enhance different areas of the body, are considered medical devices with no intended medical purpose, included in Annex XVI. of Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 on Medical Devices.

In addition to the aforementioned products, different medicines that contain botulinum toxin as an active principle are also used for aesthetic purposes in an aesthetic indication. Its use must comply with the content of its technical data sheet and take into account the information, precautions and recommendations made by this Agency. The most up-to-date information on these drugs can be obtained at CIMA, the AEMPS Online Drug Information Center.

New regulatory pathway set to support safe patient access to innovative medical technologies

MHRA is setting up a new regulatory pathway that will enable developers of innovative medical devices to receive integrated regulatory and market access input intended to bring technologies “to the forefront of the National Health Service.”

Companies that use the Innovative Devices Access Pathway (IDAP) will receive “a multi-partner support service including targeted scientific advice” from MHRA, the National Institute for Health and Care Excellence, Health Technology Wales and Scottish Health Technology Group, set out the goals of the pathway.

“The new IDAP will demonstrate how the UK regulator, health technology assessment and the healthcare system are working together to deliver safe, effective, and earlier innovative medical products to patients, establishing the UK as a center for medical innovation

Approved bodies for medical devices

Guidance on what approved bodies are, what they do and how you can become one.

The government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023. For more detail on this see the implementation update on work towards a strengthened future medical devices regime. The Medicines and Healthcare Products Regulatory Agency (MHRA) is the designating and competent authority in the UK.

Update

Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.

Medical devices: off-label use

This guidance is only relevant for medical devices on Great Britain (England, Wales and Scotland). Please note that we will continue to accept CE marked devices on the Great Britain market until 30 June 2023. Currently, from 1 July 2023, new devices placed on the Great Britain market will need to conform with UKCA marking requirements.

The government does intend to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023. For more detail on this see the implementation update on work towards a strengthened future medical devices regime.

Update

Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.

Guidance on Class I medical devices

Advice for manufacturers of Class I medical devices for placing products on the UK market.

This guidance is divided into sections on the different rules that apply in Great Britain (England, Wales and Scotland) and Northern Ireland. For Northern Ireland, different rules apply to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see the section on Class I devices in Northern Ireland below. CE marked devices will currently continue to be accepted on the Great Britain market until 30 June 2023. You will be able to self-certify your Class I medical device for the CE mark, and place your device on the Great Britain market. You will not require an Authorized Representative if you are solely placing your Class I device on the Great Britain market. If you are self-certifying your Class I medical device for the CE mark, you will need to meet the requirements of the Medical Devices Regulation (2017/745) from 26 May 2021. See our guidance for more information on the use of the CE mark for Great Britain.

Update

Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.

Medical devices: legal requirements for specific medical products

Guidance for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.

This guidance is specific to medical devices placed on the market in Great Britain. For guidance on the legislation applicable to medical devices in Northern Ireland, please see our published guidance. The government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023. For more detail on this see the implementation update on work towards a strengthened future medical devices regime

Update

Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.

DEHP phthalates in medical devices

Information for manufacturers and users of medical devices containing plastic with DEHP phthalates.

The government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023. For more detail on this see the implementation update on work towards a strengthened future medical devices regime. Phthalates are chemicals added to polyvinyl chloride (PVC) plastic to make it softer and more flexible. Di (2-ethylhexyl) phthalate (DEHP) is the type used the most in medical devices

Update

Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.

Virtual manufacturing of medical devices

Guidance for manufacturers who don’t design or manufacture devices but place their names on the product.

This document, which has been updated to reflect the changes brought about as a result of the transition period with the EU ending, supersedes the previous edition of the guidance.

The government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023. For more detail on this see the implementation update on work towards a strengthened future medical devices regime.

Update

Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.

Medical devices: software applications (apps)

Information on when software applications are considered to be a medical device and how they are regulated.

Update

Updated file ‘Medical device stand-alone software including apps’ to include information on the implementation of new regulations, updates to various links including MORE and new software vigilance guidance.

Export medical devices

Order a certificate of free sale to export medical devices outside the UK.

A CFS should not be taken as a Government endorsement of any product that is referred to on the certificate. In issuing a CFS, the MHRA does not assess or verify that the product complies with relevant export requirements and restrictions. It is the applicant’s responsibility to ensure compliance with these requirements and restrictions. Please see The Russia Sanctions Regulations 2022 and Consolidated list of strategic military and dual-use items that require export authorisation.

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.

Update

Added link to ‘Guidance: Reporting adverse incidents involving Software as a Medical Device under the vigilance system’

MHRA fees

Fees payable to the MHRA for 2023 to 2024

Update

Amendment fees added to our ‘Current MHRA fees’ webpage.

https://www.gov.uk/government/publications/mhra-fees

Register medical devices to place on the market

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

If the manufacturer is based outside of the UK, they must appoint a single UK Responsible Person to take responsibility for all of their medical devices. Please note that the accounts of any former Great Britain-based Authorized Representatives that have not updated their role to UK Responsible Person on the MHRA registration system, as well as the accounts of any represented manufacturers, have been suspended since 1 January 2022 until the UK Responsible Person has updated their role.

The UK Responsible Person will then assume the responsibilities of the manufacturer in terms of registering the device with the MHRA.

Notify the MHRA about a clinical investigation for a medical device

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.

Validation Checklist

When MHRA receive your application for a clinical investigation of a medical device our regulatory handers will validate your application against this checklist Validation Checklist- GB New Submissions (MS Word Document, 113 KB) we hope that in providing this checklist it will support you in submitting a valid application.

Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU

The European Parliament has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the validity of certain device certificates

Third Edition Guidance Document MDA/GD/0033: Medical Face Mask and Respirator

This guideline intended to provide clarification on medical face masks and respirators that are regulated under the Medical Device Act (Act 737). This document is applicable to establishments, healthcare facilities, and public dealing with medical face mask and respirators.

They are many types of masks that are available in the Malaysian market that offer a range of protection against potential health hazards. Face masks and respirators are regulated as medical devices if there are claims or descriptions by the manufacturer that makes the mask or respirator a medical device as defined in Section 2 of Act 737

According to World Health Organisation (WHO), medical face mask was divided into two categories, which is procedure mask and surgical mask. Both, are used in clinical/health care setting. This guidance document will specify the requirements for both face mask/respirators.

Medical Devices Not Registered on The Market

The Medical Device Authority (MDA) continuously carries out market surveillance. Apart from that, MDA also ensures that medical devices available in the Malaysian market are only registered and from licensed sources

The use of unregistered medical devices is extremely risky because the safety and performance of the medical device cannot be verified. In relation to that, the public and parties involved are encouraged to check the registration status of a medical device first before purchasing.

Medical Devices Not Registered on The Market

A complaint has been received regarding the use of a medical device not registered under Act 737 by a center that carries out chiropractic and physiotherapy treatment. A preliminary investigation found that the company provided chiropractic and physiotherapy services through advertisements on Facebook using medical devices to assist with treatment.

An inspection was carried out by 3 MDA Enforcement Officers to obtain confirmation of complaints around Kuala Lumpur on 30 January 2023. The inspection results found that the medical device Xavant Stimpod NMS 460 Stimpod Stimulator, Electrical Stimulator does not have a valid registration under Act 737 and is used in the center the health treatment.

Announcement of The Transition Period for The Implementation of The Use of Electronic Medical Device Registration Certificate

The Medical Device Authority (MDA) will implement the use of medical device registration certificates electronically from 2 May 2023. The establishment can download the medical device registration certificate from the [email protected]+ system after the application is completed (status complete). and payment of the registration fee has been cleared.

Both physical and electronic medical device registration certificates can be used for the purpose of importing or placing medical devices in the Malaysian market. The transition period for the use of the physical medical device registration certificate to the electronic medical device registration certificate is until December 31, 2023. During this transition period, the establishment will receive the physical medical device registration certificate according to the existing process and at the same time the electronic medical device registration certificate can be downloaded from the [email protected]+ system. In order to launch this transition process, the establishment is required to collect the physical medical device registration certificate at the MDA office after 21 working days from the date the application is completed (status complete).

The use of electronic medical device registration certificates will be fully implemented from 1 January 2024 and no more physical medical device registration certificates will be issued by MDA.

MDA Approach on Expired EC Certificate for New Registration and Re-registration of Medical Device

EC Certificate (CE Marking) pursuant to Directive 90/385/EEC and 93/42/EEC is one of the approval types that is recognised by Medical Device Authority (MDA) for conformity assessment procedure by way of verification process for the purpose of medical device registration in Malaysia.

In principal, the certificate shall be valid during the new registration and re-registration submission. However, due to the unpredictable timeline and issues with regards to the transition to the EU MDR, and to ensure continuous supply of the medical device in the market, MDA has taken an approach to allow expired EC Certificate to be used for conformity assessment procedure by way of verification process with the registered CABs if the following conditions are met:

i. The devices continue to comply with Directive 90/385/EEC and 93/42/EEC; and

ii. There are no significant changes in the design and intended purpose; and

The devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health.

Notice of the General Affairs Department of the State Food and Drug Administration on printing and distributing the “Appendix to the Medical Device Operation Quality Management Regulations: Guiding Principles for Quality Management On-site Inspection of Enterprises Specially Providing Medical Device Transportation and Storage Services” (Drug Administration Comprehensive Equipment Management [2023] No. 44)

The “Guiding Principles” are applicable to the on-site inspection by the drug supervision and management department of the business license (including change and continuation) or business filing of enterprises specializing in the transportation and storage of medical devices, as well as the daily supervision and inspection of such enterprises. During the inspection, the enterprise shall inspect the implementation of the “Appendix to the Specification” in accordance with the inspection items in the “Guiding Principles” and the corresponding key inspection contents. Enterprises that specialize in providing medical device transportation and storage services can determine reasonable missing items based on their business scope, business varieties, etc., and explain the reasons in writing, which will be confirmed by the inspection team.

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the registration and review of two medical device products including recombinant collagen wound dressings (No. 16, 2023)

Recombinant collagen wound dressings managed as Class II medical device, whose structure contains recombinant collagen components (excluding collagen components extracted from animal tissues), and used for non-chronic wounds and their surrounding skin care. Products are usually in the form of gels, liquids, patches, ointments, etc., including single-use products and products that can be used multiple times after opening, and are provided in sterile or non-sterile forms. The ingredients contained in the product do not have pharmacological effects and cannot be absorbed by the human body. If the classification and attributes of the product are not clear, it is necessary to apply for the classification and attribute definition of the product.

Recombinant humanized collagen is a full-length or partial amino acid sequence fragment encoded by a specific type of human collagen gene prepared by DNA recombination technology, or a combination containing functional fragments of human collagen.

Recombinant humanized collagen is only a type of recombinant collagen, and the material properties cannot completely determine the safety and effectiveness of the final product. The ” raw material ” in this guideline refers to the recombinant humanized collagen material used in the production of medical devices. Unless otherwise specified, “material” in this guideline is equivalent to “raw material”.

Recombinant humanized collagen is a protein produced through genetic engineering. The engineering cell construction process, quality control of production cells and routine production process control are the basis for the raw material production process and risk assessment. The main verification data in this regard can be found in The informative appendix of this guideline is a supplement to the raw material research materials, but not a necessary content of the product registration application materials. Combined with the characteristics of recombinant humanized collagen, this informative appendix is modified to quote the “General Principles of Mammalian Cell Quality Control Technology Evaluation for the Production of Recombinant Products” and “Technical Guidance for Pharmaceutical Research and Evaluation of In Vitro Gene Modification Systems” by the Center for Drug Evaluation of the State Food and Drug Administration. “Principles” and other relevant content of the Guiding Principles for Biological Products.

Notice on Soliciting Information of Participating Units in the Formulation of two Guiding Principles for Registration and Review of Medical Device Registration and Review

According to the 2023 guideline preparation plan, to further improve the technical review of related products, our center has started the compilation of the “Guidelines for the Registration and Review of Disposable Indwelling Cannulae” and “The Guidelines for the Registration and Review of Hydrogel Dressing Products”. Participating units in the preparation work are now being recruited, and domestic and foreign production enterprises, scientific research institutions and other relevant units with relevant experience are invited to actively participate.

Notice on Public Solicitation of Opinions on 7 Guiding Principles for Registration and Review of In Vitro Diagnostic Reagents, including “Guidelines for Technical Review of Estrogen Receptor, Progesterone Receptor Antibody Reagents and Detection Kits

The “Guidelines for Technical Review of Estrogen Receptor, Progesterone Receptor Antibody Reagents and Detection Kits” has now been launched. It is hoped that the production enterprises that have relevant product development, production or registration declarations will actively participate in the revision of the 7 guiding principles. In order to facilitate contact and communication, information on relevant production enterprises is now collected from domestic and overseas.

Notice on Soliciting Information of Relevant Enterprises and Units Participating in the Revision of 6 Guiding Principles Including “Guiding Principles for Registration and Review of Absorbable Surgical Sutures (2023 Revision)

The guiding role of the guiding principles of medical device registration review in the registration application and technical review work, according to the relevant requirements of the 2023 annual registration review guiding principle preparation plan of the Center for Medical Device Evaluation of the State Drug Administration, our center has launched “Guidelines for Registration Review of Absorbable Surgical Sutures (2023 Revision)”, “Guidelines for Registration Review of Absorbable Anti-adhesion Products for Abdominal and Pelvic Surgery (2023 Revision)”, “Registration Review of Absorbable Hemostatic Products Guiding Principles (Revised in 2023), “Guidelines for Registration and Review of α-Cyanoacrylate Medical Adhesives (Revised in 2023)”, “Guidelines for Registration and Review of Disposable Hemodialysis Tubing (Revised in 2023) Version) “, “Guidelines for Registration and Review of Disposable Hydrocephalus Shunts (2023 Revision)” and other six guiding principles. Participating units of the revision work are now being solicited, and domestic and foreign production enterprises, scientific research institutions, clinical institutions, etc. with relevant work experience are invited to actively participate.

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the clinical evaluation and registration review of the same variety of intervertebral fusion devices (2023 No. 20)

This guideline applies to the clinical evaluation of the same variety of conventionally designed intervertebral fusion devices. According to the current “Medical Device Classification Catalog”, the classification code of this type of product is 13-03-04, and the management category is Class III. The base material of the intervertebral cage is usually titanium and titanium alloy materials that comply with GB/T13810, and the grades are generally TA2G, TA3G, TC4 (Ti6Al4V), TC20 (Ti6Al7Nb), TC4 ELI (Ti6Al4V ELI), or YY / T The surgical implant of the 0660 is made of polyetheretherketone (PEEK) polymer. The developing wire is usually made of pure tantalum in accordance with YY/T 0966 or titanium and titanium alloy materials in GB/T 13810. Common processing techniques are machining and additive manufacturing (3D printing such as selective laser melting (SLM), electron beam melting (EBM), etc.). It is generally used in conjunction with spinal internal fixation systems for intervertebral fusion. This guideline does not include artificial vertebral bodies, new materials, specially designed intervertebral fusion devices and custom-made intervertebral fusion devices, etc.

intervertebral fusion devices that have been marketed in China, if the declared product has brand-new technical features (such as adopting a new working principle, technology, material, structural design, surface treatment, etc.), or has a new scope of clinical application If the existing data cannot prove that the declared product is safe and effective, clinical trials may be considered to obtain clinical data.

Notice on Public Solicitation of Opinions on 3 Medical Device Registration Review Guidelines including “Guidelines for Clinical Evaluation and Review of the Same Type of Absorbable Surgical Sutures (Draft for Comment)”

This guideline applies to absorbable surgical sutures made of polymer synthetic materials, which are usually used for general soft tissue sutures. Materials covered include polyglycolic acid (PGA), polyglycolide-lactide copolymer (PGLA), polydioxanone (PDO) and other absorbable synthetic materials. Conventional sutures can be single-strand or multi-strand, and can be designed as knot-free barbed sutures or ordinary absorbable sutures without barbs, which can be impregnated with suitable coatings and softeners or process. According to the current “Medical Device Classification Catalog”, the classification code of absorbable surgical suture is 02-13-06, and the management category is Class III.

This guideline does not apply to products with completely new technical characteristics (such as adopting a new working principle, technology, material and proportion, structural design, processing method, surface treatment/coating, use method, etc.), or having a new clinical scope of application. This guideline does not apply to antibacterial coated sutures such as triclosan, class I sutures (absorbable animal origin) in the YY1116 “Absorbable Surgical Sutures” standard, and absorbable surgical sutures produced by recombinant DNA technology wait.

This guideline applies to single-use hemodialyzers, including low-flux dialyzers and high-flux dialyzers, used in medical institutions for acute and chronic adult patients with renal failure for routine hemodialysis treatment . The classification code of this product is 10-04-01, and the management category is three categories.

List of Laboratories for conducting Performance Evaluation of In – Vitro Diagnostic Medical Device

CDSCO updated list of Laboratories for conducting Performance Evaluation of various categories of In – Vitro Diagnostic Medical Device.

National Medical Devices Policy, 2023

The Government of India has published plans to streamline the regulation of medical devices as part of its strategy for promoting the sector. Specific plans outlined in the strategy include changes to licensing that are designed to avoid the duplication of efforts and imposition of unnecessary compliance burdens.

The medical devices sector in India is an essential and integral constituent of the Indian healthcare sector. It forms an important pillar in the healthcare delivery system along with healthcare providers, pharmaceuticals and healthcare insurance industry, thereby helping achieve the key objectives of the National Health Policy (NHP), 2017. The medical devices constitute a multi-disciplinary sector, with the following broad classification: (a) Electronic equipment (b) Implants; (c) Consumables and Disposables (d) Surgical instruments and (e) In-Vitro Diagnostic Reagents. Further, there are categories of devices across 24+1 (IVD) sub-categories as per the CDSCO.

Consultation on GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices

This guidance is applicable to IVD device products that fall within the definition of an IVD medical device as defined in First Schedule of the Health Products Act (Act). This document provides guidance to assist product owners in risk classification 36 of in vitro diagnostic (IVD) medical devices using the appropriate risk 37 classification rules

Regulatory controls should be proportional to the level of risk associated with an in vitro diagnostic (IVD) medical device. The level of regulatory control should increase with increasing degree of risk, taking account of the benefits offered by use of the IVD medical device. Therefore, there is a need to classify IVD medical devices based on their risks to patients, users and other persons.

The risk presented by a particular IVD medical device depends substantially on its intended purpose and the effectiveness of the risk management techniques applied during design, manufacture and use. The risk presented by an IVD medical device also depends, in part, on its intended user(s), its mode of operation, and/or technologies.

HSA’s SRA status for In-vitro Diagnostic Medical Devices (IVD)

An SRA is a national health products regulatory authority considered by the WHO to apply stringent standards for quality, safety, and efficacy in its process of regulatory review of health products for marketing authorization. With HSA being recognised as an SRA for Class C and Class D IVDs, these classes of IVDs registered with HSA qualify for abridged prequalification assessment by WHO. This is a significant testament of the quality and robustness of HSA’s scientific evaluation of IVDs.

HSA being recognised as an SRA for such IVDs may be beneficial to medical device companies. Major international purchasers, e.g. the United Nations agencies, rely on the listing by the WHO Prequalification Programme. Hence, IVD manufacturers that register their IVDs with HSA may be able to use HSA’s SRA status to gain expedited listing under the WHO prequalification programme, and as a springboard for faster access to various markets beyond Singapore.