Entering a new market is challenging enough when it comes to marketing and sales, but before getting to that point all the regulatory groundwork and due diligence must have been completed. Whether for an existing device already registered elsewhere in the world and that’s similar to something already on the market in the target country, or for a new or novel device, it can be daunting attempting to understand the full extent of the regulatory landscape for your medical device or IVD.
Regulatory Intelligence for Medical Devices and IVDs
Obtaining a regulatory intelligence report will help you navigate all the regulatory complexities of getting your product to market, from document compliance screening and gap analysis to labelling and (pre)clinical testing requirements, from market access licences to fast-track authorisation possibilities.
a. Regulatory classification of the medical device or IVD.
b. Reference of all applicable legislation.
c. Body/bodies responsible for legislation(s) in the market, for example the product may require telecommunications licenses for wifi, Bluetooth and other connected devices, devices containing drug products and controlled substances
d. Details of the process for registration, change notifications or license transfers and timescales.
e. Cost (fees) of registration, change notification or license transfer.
f. Labelling requirements.
g. Testing requirements related to product registration:
i. Any tests that must be completed (in vitro or in vivo).
ii. By whom they need to be carried out.
iii. To which standards.
iv. Any testing location restrictions (e.g., will data generated in another jurisdiction be accepted / is there mutual acceptance of data?)
h. Potential issues / claims that could impact the regulatory classification.
i. Market access requirements such as appointing a Local Authorized Representative, restrictions on imports/exports, customs and duties, price controls.
j. Fast track market authorizations that may exist in the target market, for example due to the COVID-19 crisis, with specific timelines and specifications on any temporary status and controls.
k. Post-market surveillance requirements.
l. Medical device clinical trial requirements, protocol and authorizations.