The current state of medical device regulatory environments worldwide is, as ever, a mixed bag in terms of ease of market entry, registration requirements, and related compliance issues manufacturers must address in order to sell their product abroad.
But recent regulatory developments in five major markets bear mentioning. India, China, Japan, South Korea, and Brazil have all seen updates to their regulatory systems of late. Here's what you need to know.
India: Moving Toward a Formal System?
For several years, the Indian government has expressed intentions to develop and implement a comprehensive regulatory structure to oversee medical device registration in the country. Although such a system still has yet to materialize, the Indian government has taken significant steps this year toward launching more substantial medical device regulation.
Specifically, the Indian government has proposed the creation of a new regulatory body, the National Medical Devices Authority (NMDA) to oversee the country’s growing but mostly unregulated medical device market. According to draft regulations published by government, the NMDA would be responsible for ensuring the safety and effectiveness of devices sold in India, as well as setting price caps on some types of devices and boosting domestic device manufacturing. The latter is a priority issue of the current government in India.
The current Indian system, in which medical devices are loosely regulated by a division of the Ministry of Health and Family Welfare, the Central Drugs Standard Control Organization, requires registrants to prove prior regulatory authorization in the United States, Canada, Europe, Japan, or Australia, as well as submit proof of home country approval. But that only applies to a subset of 22 devices and in vitro diagnostics.
Moving toward a more robust national regulatory system would provide more transparency and predictability for manufacturers eager to tap into the Indian market.
China: Higher Fees, More Clinical Requirements
China’s medical device regulatory process has proven challenging in recent years. Frequent regulatory changes and a lack of clarity to support those changes have flummoxed foreign manufacturers undergoing registration with the China Food and Drug Administration (CFDA). But the situation has been improving gradually. Over the past year, Chinese regulators have introduced more structure and transparency to the registration process, although that process remains complicated and expensive.
Over the past year, the CFDA has formalized and clarified clinical trial requirements for medical devices, but it also expanded those requirements. Now, Chinese regulators require most Class II and Class III devices to undergo clinical trials in China before those products may be legally sold in the country. The CFDA has made some exceptions to this new rule and even established a process similar to FDA's substantial equivalence that can waive clinical trial requirements for qualifying devices.
Separately, medical device registration fees have increased substantially in 2015. According to CFDA, the new fees were established in order to boost its review capabilities and resources, but the increases nonetheless will have an impact on foreign manufacturers’ decisions on whether to pursue market authorization in China. With initial CFDA registration fees now at more than $30,000 for Class II devices and nearly $50,000 for Class III devices, it has become, in many cases, more expensive to bring a device to market in China than in the United States. The high market entry costs may discourage many smaller Class II manufacturers from entering the Chinese market.
Japan: New Law Provides More Clarity
The size of the Japanese medical device market—one of the world’s largest—is matched only by its complexity. Japan’s new Pharmaceutical and Medical Device Law (PMDL), which replaced the country’s longstanding Pharmaceutical Affairs Law (PAL) in late 2014, has impacted all aspects of the registration process, and in some cases has made the market authorization process less challenging.
For instance, the PMDL allows more Japanese market registrants to utilize third-party certification from Registered Certification Bodies instead of Pharmaceutical and Medical Devices Agency (PMDA) reviews. Previously, only devices classified as Class II Special Controlled that qualified for premarket certification could undergo RCB review.
Although the PMDL also includes strict new device labeling rules and adds quality management system requirements to Marketing Authorization Holders’ responsibilities, such measures may be somewhat offset by a new preconsultation program from the PMDA for manufacturers beginning their Japanese registration efforts. The preconsultation, or Taimenjogen, process is designed to assist manufacturers with questions regarding proper classification, appropriate submission materials, clinical data requirements, and similar issues associated with Japanese market registration. The Taimenjogen option was previously not available for registration applicants, so this new option could prove a valuable resource for foreign firms unsure of how to initiate registration with the PMDA.
Although Japan has a shrinking population, life expectancy continues to climb and the growing elderly population is in need of more medical care. Thus, Japan will remain a good market for years to come.
South Korea: Major Changes Proposed
Medical device market regulators have begun overhauling South Korea’s regulatory system to boost efficiencies as well as attract more interest from foreign manufacturers. The Ministry for Food and Drug Safety (MFDS) has already introduced a new market authorization pathway that requires Korean Good Manufacturing Practice (KGMP) certification earlier in the device registration process. The ministry has also proposed several other changes to be implemented over the next several months.
One of the MFDS’s most important changes pertains to when South Korean market registrants must obtain KGMP certification. Under existing rules, registrants undergo KGMP audits and obtain quality system certification after they begin the registration process and submit required application materials; KGMP certification is the last step to complete before registrants may begin commercializing their devices in South Korea. Following a one-year grace period ending January 29, 2016, registrants will have to undergo KGMP audits and obtain KGMP certification before submitting their applications to the MFDS.
The MFDS is also planning to regulate in vitro diagnostic devices as medical devices rather than pharmaceutical products. Affected IVD manufacturers will have to ensure compliance with the South Korean Medical Device Act instead of the Pharmaceutical Affairs Act and comply with KGMP. The MFDS will enforce phased compliance deadlines: Higher-risk Class 3 and Class 4 IVDs will have until November 15, 2015, to establish KGMP compliance, and lower-risk Class 2 IVDs will have until November 11, 2016, to ensure KGMP compliance.
Low-risk device market pathways in South Korea are also slated for reform. The MFDS is launching a new division, the Medical Device Information & Technology Assistance Center (MDITAC), this summer. The MDITAC will focus on registration and oversight of low-risk devices in order to free up other MFDS staff and resources to more closely manage and monitor higher-risk devices sold on the South Korean market.
Brazil: ANVISA Shows Signs of Loosening Up
Brazil’s ANVISA, one of the most “active” medical device market regulators in South America in terms of monitoring and enforcing requirements for manufacturers, has shown indications that it’s exploring ways to make market entry less burdensome—both externally for Brazilian market registrants and internally in terms of the agency’s own resources.
In early 2015, the Brazilian government passed a new law allowing ANVISA greater latitude to address public health risks and conduct market surveillance with more efficiency. Specifically, ANVISA now has the authority to do the following:
- Expand validity timeframes for some medical devices by up to 10 years.
- Accept quality management inspection reports conducted by other regulators.
- Expand certifications of laboratories authorized to conduct inspections and postmarket surveillance activities.
- Revamp requirements for registration transfers.
ANVISA must still develop its own regulations to take advantage of the new law’s allowances, but the fact that the regulator is now fully authorized to streamline the country’s device registration process should bode well for manufacturers interested in Brazilian market entry or expansion.
Following passage of the new law, ANVISA has extended its deadlines for technical requirement responses—that is, the time market applicants are allowed for responding to technical inquiries the regulator has regarding their Brazil registration submissions. Registrants now have 120 days, rather than 90, to respond to ANVISA inquiries.
Brazilian clinical testing rules for medical devices have also been harmonized more closely to those of international standards and agencies. By revising clinical testing regulations, ANVISA is boosting Brazil’s image as an attractive country in which to conduct clinical studies and activities.
The five medical device markets covered here reflect major discrepancies regarding ease of market entry and compliance from country to country; while regulators in Japan, South Korea, and Brazil seem to be moving toward less cumbersome requirements, China’s CFDA apparently has not taken similar steps (yet), while Indian regulators’ efforts to develop a more comprehensive registration process remain a work in progress.
|Get an inside look at FDA's 510(k) review process at MEDevice San Diego, September 1–2, 2015.|
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