Session 4.0 International registration
1. Learning objective
In this session we analyse the strategy to mark medical device globally at pre-market - and post-market stage.
2. Video
3. International registration
a. Prerequisite and condition to register medical device in new market
It is counterproductive to approach international medical device registration with the belief that the process will be completely different and challenging. Instead, begin by determining whether all necessary prerequisites are fulfilled
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 (as legal person) could be a good option to support registration if manufacturer has no own subsidiary. Normally he 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.
Home country approval
We have to mention one document in advance before gap analysis of technical documentation in many markets. It is called home country approval. You have to prove often with a legalised product certificate that subject medical device in home market is approved. Very oft it is a combination with free sales certificate.
There is always exception market as US where no home country approval is needed or China where without home country approval an extensive innovative registration is essential.
With home country approval it means you should have solid technical documentation as basis to adapt to country specific dossier. Oft the manufacturer starts international rollout especially for a new product after establishing home country market without non-compliance of product.
Market analysis is also the key for future sales. It must be questioned which product with which feature has big potential. Does the competitor exist in new market? What is the price of medical device and how are sales chain, tender process and reimbursement?
Internal resource
Besides typical budget and timeline, the internal resource plan is very critical. Every department has its own responsibility. For registration it needs priority between interested markets. So the planned personal resource with actions is primary important for the registration of most critical markets. A good project management and controlling is asked during the registration because e.g. R&D department might have capacity conflict supporting regulatory affairs and some testing is failed to continue registration.
b. Pre-market analysis
Now we decide to mark medical device in respective market. In this chapter we just want to limit the pre-market analysis to regulatory items. These are mostly ignored by the manufacturer or regulatory professional starts to make pre-market analysis late at preparation of submission dossier.
Gap analysis of technical documentation
Normally this is most extensive part during the preparation stage of registration. If local authority approves your technical documentation without deficiency, simply said, the launch of medical device will be successful.
However in the fact you can’t use all original technical documentations. So it is better to have a gap analysis of country specific documentation with current requirements in new market.
Among technical documentation the local testing and clinical data is complex and time-consuming. If a local testing or clinical trial is essential, they should be started as early as possible independent from the typical preparation packet. For some markets it needs local testing as safety, EMC, usability and wireless.
Gap analysis of quality management system (QMS)
Normally the certificate ISO 13485 is sufficient to prove conformity of quality management system. In some countries you need apply a local QMS for the initial registration as in Brazil and in Korea. And every year or in every 3 or 5 years there is renewal of certificate in which some QM documents are needed.
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 rule with fixed product group. If there were no product group matched, it might be automatically determined to innovative products.
The classification is not just to find I, II III or IV class as a number. It is related to pathway of registration in which extent the technical documentation comprises and how complex local authority reviews the dossier.
Like in US and China there is product code system. In this case you can use product code searching product specific requirements from guidance and standards.
The last point is to understand legislative of subject market and in the whole lifecycle it should be monitored, analysed and maintained. The international regulation is evolving so fast. If you start following the draft guidance till final issuance and explanation of regulation, you will fully understand the thought of authority and what they might review in focus. In this case language is a hurdle. With translation the original meaning is discounted. It could be helpful if some local consultant or even from own subsidiary could support to understand all regulatory updates.
c. Post-market strategy
After product approval it begins the control of product change. It can be form active development of next generation of approved medical device. Or the change is from passive discontinuation of component supplier. Normally the company has own change process assessing the impact of changes. Upon significant change manufacturer has different actions to make globally as starting a new registration, noticing authority about change or filing the uncritical changes in quality management system as letter to file in US.
Inspection by authority
The overseas inspection is not that representative if the production is not in that market. One of the famous inspections is Medical Device Single Audit Program (MDSAP) for manufacturer who has marked medical device in US, Canada, Australia, Japan or Brazil. The focus of inspection is quality system with country specific requirements. The screenshot below summarises all related regulation in 5 countries.
Less famous and complex inspection is in paper of quality management system. Manufacturer has to update annually, every 3 or 5 years the data of post market and quality management depending on markets.
Post market surveillance (PMS)
The top one demanding market of post market surveillance is MDR in EU. You need edit clinical evaluation, Safety and Clinical Performance (SSCP), Periodic Safety Update Report (PSUR) and Post-Market Clinical Follow-Up (PMCF).
From other markets there are similar reports in term of post market surveillance. The authority wants to monitor surveillance of medical device as of after approval data on the field.
Vigilance under PMS
After placing product in new market, there should be customer complaints. If the grade of harm of complaints by medical device is over defined serious adverse event or recall, manufacturer has to collect, report, investigate, analyse, evaluate and control the events to authority and inform users with country specific deadline.
