China – NMPA:396

Nǐ hǎo

Which photo best depicts your China regulatory strategy?

Last week I attended an excellent webinar sponsored by RAPS presented by Grace Fu Palma CEO of China Medical Devices (gpalma@chinameddevice.com). Grace provided the attendees with a very clear summary on the philosophies of the intended Chinese NMPA (ex-CFDA, ex-SFDA) programme for medical device and IVD legislation. Regulatory affairs team should always seek to obtain an understanding of the preamble and basis for health authority rationale which supports decision making thinking when determining your best approach to regulatory compliance.

The NMPA was very busy in 2020 and released 396 guidelines and notices. Such a surge surely exemplifies the impression that medical device and IVD regulation certainly looms large on their list of objectives.

The lists below provides a small sample for each category:

Industry Standards
Medical Electronic Equipment Part 2-56: Requirements for Basic Safety and Performance of Thermometers
Surgical Implants. Active Implantable Medical Devices Part 5: Circulation Support Devices
Ophthalmic Optics Intraocular Lens Part 8: Basic Requirements
YY/T 1752-2020 Basic Data Set of Medical Device Unique Identification Database
YY/T 1753-2020 Guidelines for Filling in the Unique Identification Database
Reagents (kits) for nucleic acid amplification detection – Implementation 01 Jan 2021
Artificial Intelligence Medical Device Quality Requirements and Evaluation Part 1: General requirements for datasets
Technical Review Guidelines
Guidelines for the Technical Review of Allowable Changes in In Vitro Diagnostic Reagents (Draft for Comments)
Technical Guideline on Raw Material Change Evaluation of a Non-active Device
Technical Review Guideline on Medical Device Software
Quality and Post Market Surveillance
Regulations on Surveillance and Sampling Inspection of Medical Device Quality, NMPA, 2020 #9
Specification on regular risk evaluation report of medical devices
Guidelines on Product Adverse Event Risk Assessment for Medical Device Registrants
Clinical Evaluation
Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation
Class III Medical Devices Requiring Clinical Trial Approval Catalogue (draft for comments)
Revised list of medical devices exempt from clinical trials (draft)

Many of these 396 new/updated/draft documents affect both external and domestic companies manufacturing for the Chinese market. For those corporations operating outside of China, it is vital for the global regulatory team, especially those responsible for global strategy, to ensure a thorough understanding of each document and not just rely on the translation.

Having lived and worked in many countries (including China), I truly understand the level of patience and perseverance required to successfully navigate multicultural segues. Regular communications, clear demarcation of responsibilities for project activities and real time regulatory data exchange processes, pillared in conjunction with cross cultural understanding (important whenever you are engaging with any local team) will effectively support regulatory compliance management.  

The brilliant NMPA presentation concluded with an emphasis on additional legal responsibilities for all players in the medical device marketing and supply chain, including an increase in penalties for non-compliance.

Regulatory Affairs teams: Do not rely on the lucky cat.

KimYoung@instem.com

K Young

References:

https://chinameddevice.com/

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Internal Regulatory Intelligence

All regulatory affairs professionals are aware that keeping up to date with the global regulatory environment is an essential part of the day to day job description. There will be someone on your team, no matter how large or small, responsible for monitoring the thing that is the world wide web in order to extract data pertinent to your product portfolio. The information extracted from various external repositories is reviewed, assessed, collated, analysed, processed, interpreted, communicated and archived as regulatory intelligence.

Internal regulatory data and intelligence is an often forgotten, yet critical source of information. Every organisation’s electronic files provide a rich source of data for strategic registration planning and policy creation. Those regulatory team members searching for “intelligence” must be able to access and review historical interactions coupled with product and registration data such as:

  • Average time from submission of new application/registration or change request until health authority approvals
  • Previously received queries from health authorities and acceptance of company responses
  • Quality and quantity of interactions with specific health authority personnel as relationships are developed
  • Which products with the same or similar modification were managed successfully in order to support change impact assessments
  • Which implemented regulatory strategies in the targeted regions were not successful and required re-submission or withdrawal
  • Colleague experiences during execution of previous roles
  • Lessons learned following major regulatory project activities
  • All registration history for all products across all marketed regions

Without a centralised repository for product and registration data, regulatory affairs teams will struggle to quickly and efficiently obtain the strategically valuable key information unique to their organisations that is essential to provide thorough and complete regulatory guidance to business executives. Do not allow a flawed regulatory strategy, due to lack of accurate internal data, be accountable for missing key regulatory targets which impact your revenue stream and deprive patients of life enhancing products.

KimYoung@instem.com

K Young

Combination Products: MDR and Brexit

Hashtags#: To date, LinkedIn identifies 162 followers of #combinationproducts whereas the values for followers of #medicaldevice and #pharmaceuticals are 42 thousand and >1 million respectively. I find the figure for combination product followers disheartening especially when ascribing the low number as a direct proportion of individuals interested in this product category v number of possible LinkedIn regulatory affairs professionals engaged in combination product compliance. (Granted this interpretation is woefully unscientific – just presenting the observation for debate.)

The pharmaceutical and medical device industries are diligently striving to implement procedures, processes, justifications and documented evidence to support and manage compliance against Article 117 of the medical device regulation in time for the 26 May 2021 date of application. Article 117 of the medical device regulation, these two short paragraphs, strikes fear and uncertainty into the working lives of all regulatory professionals responsible for the life-cycle maintenance of any integral drug-device combination product (DDCs) destined for the European market or those markets reliant on CE marking for registration:

“Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) of Regulation (EU) 2017/745 of the European Parliament and of the Council, a product is governed by this Directive, the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation contained in the manufacturer’s EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device.”

“If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation issued by a notified body designated in accordance with that Regulation for the type of device in question.”

The notified body, BSI Netherlands, has recently published notification to the regulatory world that they are the first to issue a Notified Body Opinion in relation to the requisites of Article 117. One adept manufacturer has already successfully manoeuvred through the process and obtained the golden chalice. There may be a glimmer of hope for those struggling regulatory operational teams, to hear the success story at a future virtual event.

The MDR also stipulates requirements for those medical devices containing medicinal substances, when the device has the primary mode of action, via classification rules 14 (medicine is integral and ancillary) and 21 (substance is intended to be introduced into the body).  

Be advised that due to (or in spite of) Brexit, the MHRA will continue to regulate DDC products and devices containing medicines, according to the EU MDD as transposed by the UK MDR 2002 (as amended). Of course, compliance is not free:

MHRA Drug-device combination products: fees

Device which incorporates a known medicinal substance from a source previously used in medicinal products or in medical devices where the MHRA has previously been consulted£4,136
Request by a notified body to the MHRA to supply an additional assessment report£818
Device which incorporates a known medicinal substance from a new source£9,640
Notified body request to the MHRA to supply an additional assessment report£2,228
Device incorporating a new active substance£42,296
Request by a notified body for the MHRA to supply an additional assessment report£10,501

As of 01 January 2021, all medical devices placed on the market or put into service in the UK must be registered with MHRA. This obligation for registration also includes medical devices, such as syringes or spoons, that are co-packaged (non-integral) with a medicinal product.

Be reminded that non-UK manufacturers must assign a UK Responsible Person (UKRP) to complete the registration process. The MHRA has allocated a grace period for the notification, based upon classification. This grace period only applies to those medical device products which previously did not need to be registered with the MHRA. If your new device to be placed on the UK market post-Brexit would have required registration with the MHRA prior to 30 December 2020, then the grace period does not apply and immediate registration is necessary.

Pharmaceutical regulatory affairs teams, please reach out to your medical device regulatory colleagues for support and collaboration. Allow them the opportunity to impart the requisite knowledge and expertise to overcome the combination product legislative challenges, for successful goal achievement – ensuring life-enhancing products remain in the marketplace for our patients.

K Young

KimYoung@instem.com

References:

MDR 2017_745

BSI Article 117 NBoP

MHRA Fees

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BLOG Intelligence

Instem provides advanced and best-in-class IT solutions & services to the global life sciences community to improve the productivity of their processes in the discovery and development of new drugs (human and veterinary), medical devices, invitro diagnostics, therapies and products. Instem delivers these software solutions and services across the entire lifecycle of product development, from concept, pre-clinical, clinical, registration to obsolescence.

This week, I would like to give a shout out to some of my blogger colleagues as Instem. In support of our mission to help clients bring their life enhancing products to market faster, every two weeks they offer experienced insight & solutions to common challenges and a platform for professional engagement.

In Silico Insider is written by subject matter expert, Glenn J. Myatt, the co-founder and head of Leadscope (An Instem company) with over 25 years’ experience in computational chemistry/toxicology. He holds a BSc in Computing from Oxford Brookes University, a MSc in Artificial Intelligence from Heriot-Watt University and a Ph.D. in Chemoinformatics from the University of Leeds. Glenn thrives on providing his loyal readership with an inside track when it comes to In Silico Safety Assessments. This blog is a must-go-to resource for scientists and professionals working in the Computational Toxicology field. https://insilicoinsider.blog/

Marc Ellison, Instem’s Director of SEND solutions, is a self-confessed SEND nerd who loves geeking out about everything to do with SEND. Marc is an active CDISC volunteer and member of the CDISC SEND extended leadership team. Be on the look-out every other Wednesday for Marc’s offering of sensible insights and subject matter expert opinions to help you navigate the challenges and opportunities that arise from the SEND standard. https://sensiblesend.blog/

The bi-weekly Pharma Whisper blog was created by Olaf Schoepke, Vice President Regulatory Solutions in order to share useful information about key industry regulations along with insights about how organizations are improving the efficiency of regulatory operations information management. https://pharmawhisper.blog/

Please be sure to pass the links for this brilliant information to your multi-disciplinary colleagues, remember regulatory success begins with effective collaboration.

KimYoung@instem.com

K Young

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UKCA for Medical Devices

I recently attended a brilliantly presented BSI webinar entitled: “UKCA for Medical devices and IVDs, are you ready?” which provided additional insight and confirmation of the UKCA conformity assessment process. I also propose a heartfelt thank you to Dr. Jayanth Katta for taking his time to provide the medical device and IVD industries with guidance.

Presentation highlights:

  1. Each legal manufacturer may assign only one UKRP in the UK
  2. EU CE marked products currently on the market in the UK may remain on the market (until 30 June 2023) however, these products must be registered with the MHRA according to the classification schedule
  3. Manufacturers continuing to market CE marked product must assign a UKRP, however they do not yet need to be identified on the labelling
  4. When BSI CE0086 certificates expire (or require amendments) they will automatically convert to UKCA certifications and be subjected to UKCA legislation

Conformity Assessment

  1. Note that conformity assessment models will differ between and amongst the UKABs
  2. BSI will start accepting UKCA applications during the last week of January but please note that they are still grappling with closing out actions relating to MDD deadlines
  3. For those manufacturers lucky enough to obtain CE2797 certification may be able to gain UKCA certification via an abridged review process
  4. For those manufacturers who obtain CE marking (directive or regulation) through a non-BSI EU NB, UKCA conformity assessment will follow the principles of EC certificate transfer

New Products

  1. BSI will endeavour to execute combined CE and UKCA assessments for medical devices whenever possible. This activity, is of course, subject to a number of caveats.
  2. The decision whether to submit and maintain combined or separate technical file documentation remains with the manufacturer
  3. Inconsistent classification should not impact a potential combined assessment

Due to the significant differences between the regulatory requirements for IVDD and IVDR, it is unlikely that a combined technical file and conformity assessment would be feasible.

During this unprecedented and challenging time, medical device and IVD regulatory professionals certainly have to keep a vast number of plates spinning in order to ensure their company’s products remain compliant for marketing. Those of you with the in decision making roles, please guarantee that your Reg Ops teams are equipped with the necessary tools and resources to support their revenue generating activities.

KimYoung@instem.com

K Young

References

https://www.bsigroup.com/en-GB/medical-devices/brexit-medical-devices/

Brexit for Medical Devices

As of 23.00 on 31st December 2020 the United Kingdom officially (and finally) withdrew as a member of the European Union (EU).

Firstly, a geography lesson: the sovereign nation commonly known as the United Kingdom consists of the island of Great Britain (England, Scotland and Wales) and the north east part of the island of Ireland (Northern Ireland).

The separation of the UK (GB + NI) from the EU has not only severed alignment with Europe but has also led to the partitioning of the application of legislation for medical and invitro diagnostic device registration, approval and marketing between Great Britain and Northern Ireland, per terms of the Northern Ireland Protocol.

Legislation Requirements

  • Products destined for the EU market must be MDR compliant as of 26 May 2021
  • Products destined for the NI market must be MDR compliant as of 26 May 2021
  • Products destined for the GB market will continue compliance with Medical Device Regulation 2002

Notified Bodies

  • UK approved body certification for NI is only valid for Northern Ireland (UKNI)
    • Note NI based manufacturers can continue to place CE and CE UKNI marked devices on the Great Britain market after 30 June 2023
  • UK approved body certification for GB is only valid for Great Britain (UKCA)
  • EU notified body certification for EU is valid for Northern Ireland (CE)

Authorised Representatives

  • UK Responsible Person is required for registration for non-UK based manufacturers to market in Great Britain
  • GB based manufacturers must appoint an EU or Northern Ireland-based Authorised Representative to market in Europe

CE Marking

  • EU will no longer accept CE certification from UK notified bodies from 01 January 2021
  • GB will accept EU CE marking until 30 June 2023 – however certification changes/updates during this period will necessitate a UKCA assessment

Labelling

  • UK CA mark mandatory on labelling for GB market from 01 July 2023
  • EU market will accept both CE and UK CA on labelling
  • CE + UKNI must appear on labelling for Northern Ireland market when certified by UK approved body
  • CE + UKNI labelling is not valid for EU

Registrations

  • MHRA will not have access to the EUDAMED database
  • All device products for GB market must be registered with the MHRA according to classification schedule (30 April, 31 August, 31 December 2021)
  • Where the manufacturer is in the UK or the Authorised Representative is in Northern Ireland, the following devices should be registered with the MHRA (no grace period)
    • Class I devices
    • Custom-made devices
    • General IVDs

These bullet points are just the highlights.

Please read the MHRA guidances and then read them again. When you think you may have thoroughly digested the information, discuss with your colleagues. Determination of how to maintain the lifecycle of your products for the EU, GB, and NI markets requires not only comprehensive knowledge of the regulations but also an intimate relationship with your entire portfolio. Implementation of a reliable electronic regulatory database is the essential tool to support compliance in this new environment, dependence on manual spreadsheets with their limitations, is significantly outmatched.

Comments respectfully requested

K Young

KimYoung@instem.com

References:

https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr

https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#contents

https://geology.com/world/british-isles.shtml

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Beautification regulated as medical devices: MDR Annex XVI

Devices without a medical purpose are excluded from the scope of the Medical Device and Active Implantable Medical Device Directives, however a group of such products are now regulated in the Medical Device Regulation 2017/745 due for application on 26 May 2021. The rationale behind their inclusion is based upon potential unreasonable risks these device types may impart upon use. The legislation applies to these products regardless of whether the point of use is at home by the end consumer or in a healthcare professional setting.

List of product groups WITHOUT an intended medical purpose now within scope of MDR:

Contact lenses or other items intended to be introduced into or onto the eye such as non-prescription lenses

Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty
Equipment intended for non-invasive brain stimulation that apply electrical currents or magnetic fields that penetrate the cranium to modify neuronal activity in the brain
High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
Products intended to be introduced through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings
Products used for dermal filling, such as substances or their combinations, introduced through injections, excluding
those for tattooing

Products under scope of Annex XVI do not need to comply with the MDR until the common specifications (CS) for the respective product types have been adopted and published by the Commission. This publication is envisaged as being not later than 26 May 2021. Adherence to the CS will be mandatory for manufacturers 6 months from date of issue or from 26 May 2021 (whichever is earlier). Note, according to the MDR implementation rolling plan, these CS were due Q4 2020, the Commission may not meet this deadline as they remain in the planning stage. Until the CS are published, individual Member States’ national qualification of products described in Annex XVI will remain in force.

Common specifications (CS) refer to technical and/or clinical requirements (other than a standard), that provide a means of complying with the legal obligations applicable to the device. It is anticipated that the CS for Annex XVI products will take into account existing harmonised standards which apply to analogous medical devices. These new CS will at a minimum, incorporate requirements for risk management and may even include clinical evaluation for assessing safety.

Overall execution of compliance for these devices must take into account the state of the art, and in particular, existing standards for comparable devices with a medical purpose, based on similar technology. Even if not yet required to comply with the MDR, Annex XVI product manufacturers need to prepare NOW for compliance:

  • assign risk classification
  • comply with Common Specifications
  • have an authorised representative in the EU, if the manufacturer is outside the EU
  • conformity assessment
  • maintain technical documentation including declaration of conformity;
  • affix CE marking
  • assign a unique device identifier (UDI) and submit data to EUDAMED
  • submit Economic Operator information to Eudamed
  • appoint a person responsible for regulatory compliance
  • maintain a quality management system
  • post-market surveillance and vigilance requirements, including field safety corrective actions and reporting serious incidents to the competent authority
  • monitor compliance for organisations in the supply chain e.g. distributors
  • maintain insurance against potential product liability.

Additionally, there are mandatory requirements for manufacturers to provide consumers with certain information, an example – implant cards for those receiving implantable devices, such as dermal fillers.

Do not exhale a sigh of relief if your non-medical device product does not currently fall under the regulation. The EC will continue to monitor for any risks identified and failure of safe performance of this product class, thus possibly (probably) adding additional device descriptions under the scope of MDR Annex XVI.

And, do not forget about United Kingdom and Switzerland……

For the manufacturers of these devices, it will no longer be a case of “sell them and forget them”.

If you are a manufacturer of an Annex XVI device destined for or already marketed in Europe and are struggling to cope, please get in touch.

kimyoung@instem.com

K Young

Yay or Nay: Comments Requested on US EUA Policies

Department of Health and Human Services

Regulatory Relief To Support Economic Recovery; Request for Information (RFI)

AGENCY: Office of the Secretary, Department of Health and Human Services.

ACTION: Request for information.

75720 Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices

The United States Department of Health and Human Services (HHS) is considering making permanent and/or keeping as temporary the regulatory standards and amendments promulgated in response to the COVID–19 crisis, issued in order to improve early access to care and reduce costs.

The HHS, via executive presidential order, has an obligation to continue to remove regulatory barriers that could be challenging to the American economic recovery. In compliance with this obligation, the Department is reviewing certain regulatory practices.

HHS intends that some of these regulatory changes and flexibilities will remain temporary, some permanent, or permanent with modification. Through the mechanism of this RFI, HHS is seeking to gather feedback and relevant evidence from the key stakeholders to support their decision making process—healthcare providers, advocacy groups; industry trade groups; health insurance issuers, research and policy experts; industry and professional associations; patients and patient advocacy groups; Medicare and Medicaid beneficiaries, and any other interested members of the public.

Here is your opportunity to help shape, amend and/or request discontinuation of the regulatory changes implemented by the FDA via the Emergency Use Authorisation (EUA).

Based upon commenters evidence, the HHS will consider phasing out or discontinuing regulatory changes that show the negative impacts outweighing any benefit of the regulatory change on a temporary basis or would have negative impacts outweighing the benefits if continued beyond the current crisis.

Attachment A of the federal register notice provides a list (note it is declared not exhaustive) of the regulatory changes for which the HHS is requesting feedback. Items 22 through 74, relate to the FDA and includes issues relating to animal medicines, decontamination procedures, ventilators, hand sanitisers and PPE equipment.

The key questions presented for comments:

Of the regulatory changes that have been made in response to the crisis, please identify which changes;

a. Have been beneficial to healthcare providers, human services systems, or to the patients and clients, and under what circumstances;

b. Have been detrimental to healthcare providers, human services systems, or to the patients and clients, and under what circumstances;

c. Have been beneficial to healthcare providers, human services systems, or to the patients and clients on a temporary basis, but would be detrimental if continued following the current crisis

Of the regulatory changes that have been implemented in response to the pandemic, please identify which changes:

a. Should be maintained only for the duration of the pandemic

b. Should be maintained permanently

c. Should be extended for a period of time, however not made permanent

d. Should be modified but maintained after the end of the pandemic, and thus made permanent with modifications

e. Should be discontinued immediately

If you are an interested party and/or a key stakeholder, to be assured that your comments are considered, you must submit your evidence electronically to http://www.regulations.gov no later 11:59 p.m. on 28 December 2020.

It must be further noted that all comments received before the close of the comment period will be available for viewing by the public.

Please see the link below to view the RFI document and the relevant Attachment A.

75720 Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020

Kimyoung@instem.com

K Young

Photo by Katie Moum on Unsplash

Taiwan UDI Draft Guideline – Highlights

Some of you may remember the Taiwan Food and Drug Administration (TFDA) Unique Device Identification (UDI) Guidance published on 30 October 2015 which kick started the voluntary UDI pilot programme.

On 05 November 2020, the TFDA published a new draft guidance document for public consultation. The guidance ​​document, “Requirements for the Single Identification Code to be Published on the Labels of Medical Devices”, outlines new requirements for the creation and application of UDI information for the medical devices and in vitro diagnostics under TFDA regulation. As the draft document is open to public consultation, concerned parties now have until 04 Jan 2021 to provide feedback via the channels listed below:

  • Webpage of the “Health and Welfare Law Search System” or “Public Policy Network Participation Platform-Zhongkai Talking”
  • Food and Drug Administration, Ministry of Health and Welfare

No. 161-2 , Kunyang Street , Nangang District, Taipei City

Tel: (02)27878289

Fax: (02)26532006

  • Email: vv741121@fda.gov.tw

The draft guideline pronounces the following requirements:

  • The single package or device body of Class II and Class III medical devices should be marked with a unique device identifier (UDI); if the single package or the device is too small, the UDI should appear on the smallest saleable unit.
  • The owner or registrant of the medical device license shall upload the product corresponding information (see below Table I) of the identification code to the TFDA medical device identification system database
  • The following medical devices are exempt from marking UDI:
    • Personalised devices
    • Special devices for export only
    • Medical devices and in vitro diagnostic medical equipment that are non-implantable medical equipment components for single use only and are not used separately and sold.

The draft also states that the coding principles will generally follow the International Medical Device Regulators Forum (IMDRF) recommendations.

Similar to other regional UDI database requirements, the owner or registrant of the medical device license shall register on the UDID platform before the device enters the market. If a device change results in an updated DI, the owner or registrant of the medical device license, must upload the new DI and corresponding information into the UDID prior to the new product entering circulation.

Mandatory implementation for Class III implantables to begin 01 June 2021.

Table I: Information to be provided to TFDA UDID

Timelines and data exchange requirements to meet the ever evolving global UDI obligations must be captured in your regulatory assessment and regulatory strategy communications.

kimyoung@instem.com

K Young

References

Photo by Charlie Solorzano on Unsplash

China UDI:Medical Devices

For those regulatory professionals who thought the UDI quagmire was sorted, have you thought about the unique identification requirements as legislated by Peoples Republic of China via the NMPA? On 10 August 2020 the NMPA launched Unique Device Identification (UDI) Database on its website.

  • From 01 January 2021 (43 days from blog posting date)
    • the first group of 64 Class III medical devices shall have unique identifiers
Please be aware, even though only 50 data attributes are necessary for submission to the China UDID database, less than US FDA and significantly less than under MDR, 30% of these attributes are UNIQUE for China UDI. Thus, yet another set of regulatory data to capture and maintain.

It really took a bit of trolling through the internet to finally find a complete list (in English) of the 64 devices assigned for the first phase of UDI implementation (It would appear that access to English translations of the 64 product names are carefully shrouded in unobtainability ):

The Chinese medical device and in vitro diagnostic market is growing substantially. When conceiving and articulating your global regulatory strategy, the requirements for global UDI demand to be at the forefront for accurate decision making. Regulatory professionals, ensure that senior management understands your operational workflow constraints and prerequisites for capturing, maintaining, accessing, amending and transmitting global UDI data necessary for maintaining compliance and therefore marketability. Compliance translates into revenue and patient satisfaction.

As always, please refer to the original NMPA data sources for confirmation of requirements as translations may be inaccurate.

KimYoung@instem.com

K Young

REFERENCES:

National Medical Products Administration (NPMA)

NMPA UDID CIC Message Mapping-Aug2020-v1.0-en

NMPA UDID to GDSN Attribute Mapping 20200609 v1.5

Quick Guide for NMPA UDID GDSN Testing-Sep2020-v1.1-en

https://udi.nmpa.gov.cn/

GSI China: http://gmd.gds.org.cn:8080/index.php?doc-view-43601

China Medical Device https://chinameddevice.com/udi-nmpa/

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