Updates of Medical Device Regulatory System in 5 Major Markets

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.

References: http://www.mddionline.com/article/global-regulatory-update-2015-07-28-15

Foreign Capital Investment in Healthcare: China, India and Brazil

A report by the World Health Organization (WHO) on healthcare financing systems for universal coverage of 2010 suggests discussing innovative ways to increase health investment funds at a global level.

As an example of change in the entire healthcare management system is China, which has pledged by 2020 to provide health services "safe, effective, convenient and affordable" to all urban and rural residents with "a medical clinic and a hospital in each region of the country". In addition to the US $ 124 billion initially invested to restructure out-dated services, the government authorized foreign capital investment across the Chinese healthcare market, including tax incentives in some cities.

India’s situation is similar to Brazilian’s reality: lack of healthcare professionals and poor infrastructure. In 2007, the strategy to raise more money, and restructure healthcare, has allowed foreign capital investment in hospitals, which brought benefits to the country, according to a report by Rupa Chanda, published by the World Health Organization.

Brazil has recently changed the law nº 8.080/1990 and now authorizes foreign capital investment in hospitals.

References: http://saudebusiness.com/noticias/investimento-de-capital-estrangeiro-ja-muda-a-realidade-de-china-e-india/

http://saudebusiness.com/noticias/capital-estrangeiro-em-hospitais-como-alternativa-para-as-instituicoes/

Reconsider Outsourcing Strategies in China

In the last couple of decades, China has attracted manufacturers from all over the world because of low labor costs and excellent export infrastructure. By outsourcing their production, China was a way to cut costs when producing big quantities. The medical device sector was no different than that.

However, this trend may be about to change. Chinese wages and the value of Chinese currency are rising. The government mandate to raise the minimum wage, so it could bring labor cost increases of 15–20% per year in Chinese factories. Meanwhile, freight and other costs associated with offshore manufacturing are continuing to rise. There are other risks when outsourcing in China, such as intellectual property protection and quality control.

So manufacturers are rethinking their strategies of outsourcing in China. Some US-based are returning their production back to the United States. This is particularly good when the product is meant for the American market. This reduces shipping costs and challenges, gives OEMs a higher quality control and allows them to take advantages of improving efficiencies in U.S.-based manufacturing.

References: http://www.mddionline.com/article/could-onshoring-be-next-medtech-outsourcing-trend