A Guide to Effective Regulatory Strategies

Regulatory Strategist to Introduce Medical Device in Market 

Once medical device design and development is in place, it is very important for medical device manufacturers to introduce the device in maximum possible Market to sustain their financial goals  

For any medical device manufacturer, it is very challenging to meet Global regulatory requirement at a time. So many a times companies adopt approach of clearing a medical device in one of the major Market places, either Europe or USA and get help of this gathered information to comply regulatory requirements of rest of the countries. 

Normally, ISO 13485 quality management system forms the basis of regulatory clearance as well as it can be considered as starting point for medical device single audit program (MDSAP). 

As there will be increasing complexity of medical devices and associated risks, there will be increasing complexity of regulatory requirement. In addition to this, with changing regulations for example, in case of change in regulations from EUMDD to EUMDR, meeting to the device regulatory requirements to gain access in respective Marketplace is going to be more challenging tasks for medical device manufacturers who wish to continue marketing of their devices in EU market. 

We, at operon strategist along with expert regulatory team are constantly monitoring these changing complexities of regulatory requirements and can help medical device manufacturers to place their medical devices in the global market with appropriate compliances of respective regulatory requirements needed. 

Why it is important to create effective regulatory strategy for medical device? 

Development of medical device is a big competitive as well as economics challenge for any medical device manufacturer.  Although there is huge growth in medical device requirements, increasing complexity of regulatory requirement is also a major burden for medical device manufacturers.. 

Therefore, it is very important to design appropriate regulatory strategy to gain competitive advantage for sale of medical device, which can be achieved with appropriate planning. 

Defining a Regulatory Strategy 

Plan for creating a regulatory strategy should start with identification of market place of interest which again depends on economic challenges of respective manufacturer. 

If there is primary requirement to meet economic challenges, medical device manufacturers can identify non-regulated or Semi-regulatory markets in which regulatory requirements are minimal to get market clearance and access to the respective market. 

Economic challenges of respective markets can be identified by competitive cost of medical device under consideration, ROI (Return on Investment), demand of medical device etc. 

Once the market is identified, further regulatory strategy can be planned by considering: technical as well as financial resource available. Here, Operon Strategies can serve as your technical resource. 

Advantages of Potential Marketplaces 

• If medical device manufacturer considers Europe or US and potential Marketplace, these markets have some advantages because US is the largest single market for medical device and Europe is next emerging opportunity for medical device. 
• If you get a clearance or regulatory approval for US or EU market, this is accepted by many countries for gaining market access with further minimal regulatory requirements. Ex. CE (Europe) or 510k (US) approvals are well accepted by CDSCO (India) to import medical device.  Some technical performance and safely data generated during CE/ 510k approval can be submitted to CDSCO in their format to gain import license for respective medical device, which can be for the marketed in India. 
• Another advantage of US 510k approval is that approval process can be completed in stipulated time predefined by US FDA and once your device gets 510k approval, you need not to go for renewal if you are not making any design or application changes to it. 
• Once the medical device get CE marked, respective device can have benefit of access to various countries of Europe. Though Brexit (UK leaving from EU) has an exception, the technical documentation as well as performance and safety testing conducted during CE certification can be used for application of regulatory approval to Brexit with nominal notifications 

Summary: 

To create effective regulatory strategy of medical device; every medical device manufacturer should consider 

1. Choice of market based on economic and other parameters
2. Regulatory requirement of respective market
3. Identification of Technical resource
4. 4. Identification for performance and safety requirements and respective data generation 
5. Creating technical documentation in compliance with regulatory requirements

We at operon strategist can help you to create, implement and gain necessary approvals by adapting effective regulatory strategy for your medical device