WIMAS 2015: International Workshop on Additive Manufacturing for Healthcare

WIMAS (International Workshop on Additive Manufacturing for Healthcare) took place in Campina Grande, Brazil from November 18-20^th. The event gathered together representatives from several different sectors interested in applying additive manufacturing (commonly known as 3D printing) in healthcare. Among the guests, there were people from the academy like researchers from IME  (Military Institute of Engineering) from Rio de Janeiro, NUTES (Center of Strategic Technologies for Health) and the team from the Sao Paulo-based Renato Archer Institute. There were also representatives from regulatory bodies like ANVISA (Brazilian Health Surveillance Agency) and the FDA; public institutions like the Ministry of Health and the SENAI Innovation Institute. Besides people from the private sector and companies like URI Medical and Biokyra.

      During the event, it was discussed relevant strategic issues for the application of the technology in healthcare as the development of protocols throughout the model building process, from segmentation of the medical image, i.e. regulate programs that make this process, until the manufacturing process used for materialization of the implant or biomodel, besides the form of sterilization and the risk ratings for each 3D printed product.

In addition to the round discussions, Biokyra had the opportunity to present the surgical cases that have recently been done and the products that are being developed within the company.

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

Brazil’s Medical Device Market: Opportunities and Challenges

As an important emerging market that has captured the attention of foreign medical device manufacturers, Brazil currently imports 60% of its medical equipment, amounting to US$1.9 billion. With 200 million inhabitants, an Unified Health System (SUS) and an estimated 36 million Brazilians ascended into the middle class within the past four years, public and private partnerships are necessary to increase the access to a better standard of care demanded by the Brazilian people.

However, this attractive market also shows some challenges. This is especially true when it comes to registration and certificates system, audits processes, administrative and import obstacles. ANVISA is Brazil’s National Health Surveillance Agency that suffers from processes delays and lack of professionals. Some initiatives have already happened in order to facilitate registration processes and market access, as  the Memorandum of Understanding that was signed by U.S., Canadian and Australian Notified Bodies with their Brazilian counterparts in 2012.

References: http://www.emdt.co.uk/daily-buzz/opportunities-abound-brazil-medical-device-market-expect-delays?cid=nl.emdt03

Brazilian Health Surveillance Agency simplifies Import processes

Anvisa (Brazilian Health Surveillance Agency) is adopting actions in order to improve the import processes of healthcare products. RDC 15/2014 introduces significant changes to the Certificate of Good Manufacturing Practices and aims to help the new technologies’ registration in Brazil.

First significant change is to validate auditing reports made by third parties  (other regulatory agencies). Also, Anvisa will no longer emit certificates for lower risk products, as gloves, syringes and some surgical devices. Although this measure removes the need for inspection,  it does not change the criteria of effectiveness and security required. Finally, Brazilian Health Surveillance Agency will allow that the protocol of the certificate request is accepted to submit registration applications, maintenance and amendments of highest risk products. This means that a manufacturer will no longer need to wait  for grant of certificate to have an analysis of his products started. With the two processes happening concurrently, the time of arrival of new equipment in the market should be reduced.

References: http://saudeweb.com.br/42867/anvisa-simplifica-processo-de-importacao-de-produtos-de-saude/

Another Attempt to Globalize the Medical Device Industry

When it comes to a globalized economy, one obstacle always bothers the free trade: the regulatory systems of the countries. To stimulate the global economy and favor the free international trade, it is important to think of a way to converge rules and so, the free movement of goods will not become a slow bureaucratic process. As for a harmonized regulatory system for medical devices, the task is even harder because it also deals with national health laws.

This was the concern when in 1992 the European Union (EU), the United States, Canada, Japan and Australia gathered together to establish a method to harmonize the regulations on medical device. The voluntary group was called Global Harmonization Task Force (GHTF) and brought together representatives from medical device regulatory agencies and the regulated industry from its founding members.

Almost 20 years later, the new economic scenario called for new representatives. So, “to build on the strong foundation work of the GHTF and to accelerate international medical device regulatory harmonization and convergence”, the International Medical Device Regulators Forum (IMDRF) was conceived in February 2011, replacing the GHTF. Besides the original 5 founding members of the GHTF, it included Brazil to the discussion of future directions in forming an international harmonized and convergent regulatory system for medical devices.

The membership of China and Russia are currently being confirmed and the new Forum, including the 6 official members, China and the WHO (World Health Organization, an observer member), met in Ottawa in October 2011 to establish strategic topics for its operation.

Trying to standardize rules among the GHTF member countries was a big challenge, now with the creation of the IMDRF and new members added, the debate becomes even harder. Despite the adversity, the future results might turn out to be stronger and more creative once it takes into consideration different points of view. There is still a long way of hard work to build a harmonized and convergent regulatory system, which provides solutions to all the five countries and EU’s concerns. We hope the members create an environment of dialog to accelerate the harmonization and convergence of their regulatory systems, so that we could have a real “international medical device regulatory system”.

References: http://www.imdrf.org/

Brazilian Health Devices Industry Growth Disappoints

The Brazilian Association of High Tech Industry of Medical Equipment, Products and Supplies (Abimed) has recently shown the unsatisfactory results of the Brazilian health devices industry in 2012. Although it has grown above Brazilian growth rate (around 2%), the sector expected a higher progress at the beginning of the year.

The health devices market presented an increase of 4,2%, the industry showed a rise of 3,2% and the sector has created 5 thousand new jobs, which represents an increase of 3,2%.

There are many explanations for this disappointing fact. The national economic growth presented a terrible performance (not only because of the international crisis, but also because of the Brazilian structural problems), the National Health Surveillance Agency strike which jeopardized the health market supply and the slowness on inspections at international factories. Abimed also indicates that the devaluation of the exchange rate and the absence of support for innovation and local production postponed the development.

However, the Association believes there is space for a 10% rate of growth in 2013.

“Brazil is the sixth economy in the world and it represents a 2,8% in World’s GDP, but only a 0,5% in the world’s health devices market. (…) we believe in the economic recovery.”

Carlos Goulart

President of Abimed

References: http://saudeweb.com.br/34165/setor-de-produtos-para-a-saude-cresce-abaixo-do-previsto-diz-abimed/

Brazil and the Global Harmonization Task Force (GHTF)

According to the FDA, the Global Harmonization Task Force (GHTF) fosters international harmonization in the regulation of medical devices. Regulatory and industry authorities from Europe, Asia-Pacific and North America collaborate to encourage the harmonization of regulatory practices to ensure the safety, effectiveness and quality of medical devices.

The GHTF was founded in 1992 and its main purpose is to standardize medical device regulations around the world by the exchange of information. Some of the benefits of the standardization are the convergence in regulatory practices related to ensuring safety and facilitating international trade.

On November 11, Brazil, Argentina, Colombia and Cuba’s regulatory agencies agreed to work in cooperation, through the inspection of manufacturers of medical devices in each country. The Brazilian regulatory agency (ANVISA) requires a Good Manufacturing Practices (GMP) certification from medical devices manufacturers, and the inspection is conducted by the agency itself. From January of 2013 the GMP certification issued by the Argentinean, Colombian, and Cuban agencies will be accepted in Brazil as well, which means more efficiency in the certification process.