Stewart Eisenhart / Senior Regulatory Analyst / Emergo Group
If the title of this article sounds pessimistic, it’s for a reason. Compared to the highly evolved medical device markets in the U.S., Europe and Japan, the growing BRIC markets–Brazil, Russia, India and China–continue to perplex new entrants.
The BRIC markets have long been pursued by device manufacturers as attractive alternatives for generating new business. However, these emerging markets are presenting their own challenges, in terms of regulatory structures and enforcement, transparency (or lack thereof) and associated costs.
Brazilian regulators may ease quality system audit requirements
Brazil’s medical device market is the biggest and most dynamic in South America, but the country’s registration process is anything but easy for foreign manufacturers. Recent moves by ANVISA, Brazil’s medical device market regulator, suggest that the agency has grown more aware of registration challenges and begun loosening some requirements for applicants.
Brazil’s participation in the Medical Device Single Audit Program (MDSAP), under which regulators in the U.S., Canada, Brazil and Australia will accept quality system audit reports from one another, should prove particularly beneficial for foreign manufacturers eager to register with ANVISA but not so eager to undertake the effort and cost of Brazilian Good Manufacturing Practice (BGMP) compliance.
Once the MDSAP is fully implemented, manufacturers with devices already registered in the U.S., Canada or Australia will be able to submit their ISO 13485 certificate (or FDA inspection report) without having to meet additional BGMP requirements. Implementation dates remain unknown, but now it’s a question more of “when” than “if.”
Russia’s regulatory process still enigmatic
Medical device registration requirements in Russia often strike foreign manufacturers as highly complicated or highly opaque –and sometimes both. Although the government recently shook up leadership and staff at the Russian medical device regulatory agency Roszdravnadzor (RZN), the sometimes arbitrary process of obtaining approval to sell devices there can still befuddle first-time registrants.
This year, Roszdravnadzor implemented a plan to make market registration for low-risk Class I devices easier, but also introduced rules making its change and amendment approval process more difficult:
• First, Class I devices submitted for RZN approval now only undergo one round of quality and safety review, rather than two as was previously the case. The new rule also exempts Class I devices from “clinical trial” requirements, which pertain to both clinical data and actual clinical trials conducted in Russia; registrants must include any previous clinical data in their submissions to Roszdravnadzor. This change was made primarily to lessen the huge backlog of applications awaiting RZN review.
• On the other hand, manufacturers whose devices are already registered for sale in Russia must meet additional requirements if and when they need to amend their instructions for use or technical documentation. Under the new rule, all modification requests must undergo review by Expertise Centers just like new registrations do. These review requirements may lead to longer approval times and additional costs for manufacturers needing to change or modify their Roszdravnadzor registrations.
Based on the example of these two recent developments, it appears that Russia will continue to be one of the more challenging markets going forward; additional reforms similar to that for Class I device registrations would, however, attract greater interest from foreign firms.
India: Signs of a formal regulatory system on the horizon?
Will 2015 be the year that the Indian government actually establishes a formal medical device registration system? Signs are encouraging, but then again, India has been talking about regulating a broader array of devices for many years.
The country’s latest moves in this direction include, most notably, plans to establish the National Medical Devices Authority, or NMDA, and to regulate India’s highly fragmented medical device market. Pending Indian parliamentary approval, the NMDA would take over market oversight duties from the Central Drugs Standard Control Organization (CDSCO).
Unlike the CDSCO, the NMDA would be solely responsible for medical device regulation, not drugs as well, indicating that the Indian government is willing to devote more discrete resources to overseeing the country’s medical device sector.
Current CDSCO regulations apply to an odd mix of only 22 devices and IVDs, requiring proof of prior registration in the U.S., Canada, Europe, Australia or Japan, as well as home country approval. Expanding its regulatory system to include a broader array of medical devices and IVDs would lead to a more predictable process for registrants in India.
Higher costs for Chinese market entry
Although the Chinese Food and Drug Administration (CFDA) has taken steps to address challenges such as poor transparency and unpredictability in the Chinese medical device registration process, satisfying Chinese registration requirements will remain difficult for many foreign manufacturers.
One major barrier to market entry in China was introduced recently in 2015 by the CFDA: The regulator raised its fees significantly for Class II and III device registrations. Class II registrations now cost roughly $30,000 for imported devices, while Class III registrations cost about $50,000.
Although successful commercialization in China can prove highly lucrative for foreign device manufacturers, ongoing challenges in terms of meeting CFDA requirements, now coupled with heftier application fees, may cause additional difficulties particularly for smaller Class II device companies lacking the resources needed for Chinese market entry. Companies looking to enter the Chinese market are well advised to seek a professional opinion to determine what, if any, clinical data will be required to support their registration.
Conclusion: Look before leaping
Given disparate market and regulatory characteristics across the BRIC countries, deciding whether or when to undertake device registration in one or any of these markets should involve several careful considerations.
Whether it makes good business sense for a medical device manufacturer to expand into one or more BRIC markets depends on that firm’s individual resources, growth strategies and cost-benefit analytical foresight.