International registration for start-ups and Small and medium-sized enterprises

International registration is at late stage of product whole life cycle. However the plan of international registration impacting quality, safety and performance of medical device (law, guidance, standard, country specific feature, regional labelling) should be considered as user need in early design stage. The change of first product marked triggers design change assessment and as bundle a new generation of product which should developed and verified in new design and development.

Especially for start-ups and Small and medium-sized enterprises is market access of international markets not easy to plan as:

• No prototype to show stakeholder
• No similar competitor
• No time and cost
• No manpower for RA and QM
• No resource in each market
• Not sufficient technical documentation

Often an urgent international registration is needed due to sponsor, distributor, and beneficial regional legislative. The manufacturer has to react and to learn by doing a registration.

We dedicate this article for the ignored controlled “plan” and “lessons learned” for start-ups and Small and medium-sized enterprises of medical device, because everybody could do, check and act.

There are huge regulatory intelligences (shortcut) for all stakeholders to create and follow.

1.    Market analysis

The trigger of placing a product in respective market is potential return to asset there and need of patient.

Here the information through sales-, product management and local distributor must be collected and evaluated.

Besides these factors could impact the win of planned medical device at markets:

·        Local buying volumes

·        Competitor analysis

·        Reimbursement

Very critical is time and cost to place product at markets, please make deference about:

• Evaluation time
• Preparation time of dossier
• Review time by authority
• Deficiency reply time by manufacturer
• Market access time before final product release
• Official cost
• Cost of consulting
• Cost of additional testing, translation, legalisation of documents
• Cost of RA and Co.

KPI: market analysis, time and cost for registration

2.    Legislative of medical device

The legislative of medical device evolves rapidly, so for sure to book newsletter, to visit webinar or even to join a training or eLearning can at least guarantee to get informed in time to new regulation.

We suggest at least for new registration, manufacturer should ask for, study and record:

• Law in subject market
• Classification rule
• Guidance related to technical documentation
• Guidance of labelling
• Guidance of change notification
• Guidance of quality management if applicable
• Guidance of post market
• Official resource of time and cost

The good proposal either intern or outsourced to consulting should have gap analysis of registration, because exact the gap takes long to be catched. We analysis the critical gaps to start a registration in a free proposal.

KPI: gap analysis for registration, updated legislative of international market

Gap analysis: classification and product code

The first question to mark product in a new country is to determine whether subject product belongs to medical device. In many markets there are classification rules or fixed product group (often with a product code).

The classification is not just to find I, II III or IV class as digits. It is related to pathway of registration in which extent the technical documentation comprises and how complex local authority reviews the dossier.

Gap analysis: Pre-requisite

For most markets the legal manufacturer has to prove country of origin:

• Product certificate
• ISO 13485 (rarely ISO 9001)

Gap analysis: time and cost, technical documentation (item 6), country specific testing

In our eLearning you will get the free evaluation form to make a registration strategy plan or you can ask for a template with more details

KPI: pathway of international registration, technical documentation in each market

3.    Model or configuration management (related to item 10)

Many manufacturers have their country specific model managements. So not all home country approved products have an international journey. It is recommended to start to best-selling model followed by others.

Even for one medical device especially with software, to make an easy and fast registration it is better to select standard module to mark. Here are reasons to consider to have differentiated model or configuration management:

• Market need
• Cost of registration
• Production capacity
• No manpower of RA
• Avoid regulatory hurdle as no equivalent device to compare as needed

Unfortunately we see many manufacturers have maintained renewal of old medical device models with more efforts and without sales records.

KPI: release management, international configuration

4.    International partner

We believe that for start-ups and Small and medium-sized enterprises, you don’t have immediately in each market a partner or even subsidiary.

Distributor might be the first contact person deciding your success in a new market. He should have a supply network of similar product and can predicate the potential market share. On the other side at distributor site, a warehouse with storage and transportation condition should be guaranteed. It is worthy to plan a regular audit there.

In the most case the distributor does registration too. However it could be tricky if you want to change distributor because in some markets as registration holder you can`t easily change distributor without letter of attorney of old distributor.

Consulting company could be a good option to support registration if manufacturer has no own subsidiary. Normally he as legal representative plays a neutral role making registration in term of after approval sales. As experienced consulting company the quality and efficiency to mark a product is way better than typical distributor. Besides it, consulting can assist well post market activities as vigilance and monitor regulatory update.

KPI: selection and qualification of critical supplier, contract of extern partner

5.    Quality management system

If the pre-requite of ISO 13485 is fulfilled, in many markets a frequent quality management in paper check or onsite is possible. These are typical requirements for quality management:

MDR

MDSAP

Brasil GMP

Taiwan QSD

Japan GMP

Overseas inspection

The final purpose is to achieve recertification to be able to place the medical device in market.

KPI: quality management in home and international market

6.    Technical documentation (waht to submit to authority)

At the end a dossier also called technical documentation (TD) should be submitted. Depending on requirement the TD will be differently complied which brings more efforts and non-understanding by long years MDR or FDA experts for international registration. These TD can be:

• Device description (comparison with similar product)
• Marketing history
• Country specific application form
• Testing report to special regional standards (as Chinese type testing)
• Regional IFU and label
• Documents related to production site

Fortunately the following standard-TDs have always some content and can be used everywhere:

• Home country certificate
• Risk management
• Verification and Validation report
• Biocompatibility report
• Packaging report
• Production workflow

So for many manufacturers it is unknown that you could even submit a TD in many markets with drafted device description, risk management, testing report and instruction for use which means in one side that the TD should be in compliant to ISO 14971 (risk management), on the other side that the new revision is not critical.

Indeed the technical documentation is only a part of design and development or design history file. During the short or long review, deficiency rely stage, it should be corrected (added or removed) and updated so it is best basis for next registration.

The transfer of TD to stipulated language, in wished format to regional guidance, in suitable wording to authority is the fun and pain at intentional registration of medical device.

KPI: technical documenation

7.    Post market activities

After product approval is more or less before next post market activities.

The reactive post market activities are:

• Customer Complaints
• Adverse event- and recall reporting

The active post market activities:

• Registration of manufacturer
• Registration of UDI
• Renewal of certificate
• Assessment of product design change
• Renewal of quality management system in some markets
• PSUR PMCF SSCP in EU

These efforts of post market activities should be considered as a factor whether to renewal an old model of medical device in new generation plan in item 10.

KPI: international change assessment and vigilance system

8.    Monitoring of registration (“lessons learned” in whole product life cycle)

The information of regulation, TD and other upcoming post market activities for diverse markets can be explosive.

A tool of Customer Relationship Management (CRM) either extern or intern must be created for the whole company to follow.

Even for start-ups and Small and medium-sized enterprises, the valuable info can be written in

Excel

SharePoint or other Drive

OneNote

The purpose of this tool is to find all data ideally with a button and to avoid any critical timeline of international activities.

*we are always ready to create any digital tool with you. Even with our knowledge of computer system validation, a tool of registration can be showed to any notified body.

KPI: project management, tracking system of international registration

9.    Resource as Regulatory affairs manager (related to all items)

The key person for international registration is regulatory affairs manager. For start-ups and Small and medium-sized enterprises it can be started by any employee with support of international partners. However the knowhow introduced in item 8 including the experienced should be recorded well and by an assigned professional called regulatory affairs manager. See another article about soft skills of RA manager.

Alternative for a complex project of international, the registration can be outsourced by a third person or firm, namely interim regulatory affairs manager.

Another resource for a complex international registration must be evaluated. The stakeholder can be:

• Project manager
• Product manager
• Research experts
• Testing engineer
• Quality manager
• Outsourced labs

The idea project management is not 100% project plan which will never happen, but made of

• Focus on the critical tasks
• Communication through all participants especially to authority
• Delegation of task to correct person
• Control deadline to milestone with measurement

KPI: resource management, regulatory affairs manager

10. Next generation development (related to item 3)

After initial registration and sale in subject market, for most manufacturers they react for registration of next generation because

• Since 10 years same model on market
• Passive change of critical components
• Distributors own wish
• Competitor has new features of products

The clever manufacturers will selectively start prioritised international registration. Even for the transition of generations, manufacturer could decide to make change registration (1 model at market) or to make a new registration (2 models at markets).

There are experience from last registration and current status of feasibility to decide when, what and how to mark a new generation model.

KPI: stakeholder requirement, international product matrix, criterion for next registrationa

How can we support

If you want to control international success of medical device at international markets, book a personal workshops or our regulatory KPI kit.

Our most critical controlling finding is not to have an international procedure (registration, vigilance, change assessment).

A good news besides MDR or MDSAP certification, these procedures are never or rare proved by international authority. So you write procedure and records improving your efficiency of regulatory affairs.