As the world does not
agree on a harmonized medical device regulatory system, manufacturers face
different scenarios in terms of market entry, registration requirements and
compliance issues to be able to sell their
products in foreign countries. Therefore, it’s important to monitor regulatory
updates in major markets.
Brazil:
ANVISA (Brazilian
Health Surveillance Agency) has shown intentions to make market entry less
burdensome—both externally for Brazilian market registrants and internally.
Early this year, the government passed a new law, which allows ANVISA 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.
However, the regulator is now fully authorized to streamline the country’s
device registration process. ANVISA has also extended its deadlines for
technical requirement responses: 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.
India:
Although a
comprehensive regulatory system has not yet been implemented, the Indian
government has adopted significant actions to launch a more substantial medical
device regulation. The government has proposed the creation of a new regulatory
body, the National Medical Devices Authority (NMDA), a step towards a more
strong regulatory system, which would provide transparency and predictability.
China:
Despite recent
initiatives towards a more structured and transparency to the registration
process, China’s medical device regulatory system remains complicated and
expensive. China Food and Drug Administration (CFDA) has formalized and clarified
clinical trial requirements for medical devices and even established a process
similar to FDA's substantial equivalence that can waive clinical trial
requirements for qualifying devices. However, medical device registration fees
have increased substantially in 2015. In many cases, it’s more expensive to
bring a device to market in China than in the United States.
Japan:
The Pharmaceutical and
Medical Device Law (PMDL), which replaced the country’s longstanding
Pharmaceutical Affairs Law (PAL) last year, has impacted all aspects of the
registration process. PMDL allows Japanese market registrants to utilize
third-party certification from Registered Certification Bodies instead of
Pharmaceutical and Medical Devices Agency (PMDA) reviews. There is also a new
pre consultation program for manufacturers beginning their Japanese
registration efforts.
South
Korea: The Ministry for Food
and Drug Safety (MFDS) has already introduced a new pathway that requires
Korean Good Manufacturing Practice (KGMP) certification earlier in the
registration process. MFDS has also suggested other changes to be implemented
over the next months. The ministry is also planning to regulate in vitro
diagnostic devices as medical devices rather than pharmaceutical products,
which manufactures will have to ensure compliance under the South Korean
Medical Device Act instead of the Pharmaceutical Affairs Act and comply with
KGMP. Low-risk device market pathways in South Korea are also scheduled for
reform.
