This recently re-focused page on our website aims to bring you coverage of  medical technology developments around the world.

For information and photos about our China Mission, click on to our Special Promotions page.

For information about the Ukraine project, you can click on to our Global Focus page.

KFDA to eliminate certain requirements for foreign devices

In a move likely to ease the way for foreign medical device manufacturers, the KFDA is planning to eliminate certain requirements for certificates of product approval. Manufacturers must currently submit a copy of the product approval in the country of manufacture, the approved technical file, the approved type test, and a list of the facilities.

Currently, medical devices manufactured outside of Korea must be approved in their country of manufacture before they can receive product approval in Korea. The manufacturer must submit a valid certificate issued by the government within the last two years. However, the KFDA is currently taking steps to eliminate this requirement. In the future, foreign device manufacturers would be able to apply for product approval in Korea before receiving approval elsewhere. This change is expected to be implemented mid-2009.

While the approved technical file will still be necessary, the KFDA also plans to eliminate the requirements for a copy of the approved type test, as well as a list of the manufacturing facilities. The type tests are conducted by a KFDA-registered third-party lab that physically tests samples submitted by the manufacturer. These changes should also be implemented mid-2009.

To make the product approval process more efficient, the KFDA also recently announced a new risk classification system, which will be effective beginning July 1, 2009. The current risk classification system has four classes that encompass 1,012 classifications: Class I, or low risk, contains classifications such as surgical instruments; Class II, or low-moderate risk, contains classifications like hypodermic needles; Class III, high-moderate risk, contains devices such as orthopedic implants; and Class IV, high risk, contains devices such as implantable defibrillators. The new system will contain around 2,000 classifications separated into the four risk classes.

For pre-market approval, device manufacturers with Class II-IV devices are required to obtain a certificate of product approval, a device business license, and KGMP certification. The product approval certificate and business license are permanent, but the KGMP certificate is only valid for three years and will need to be renewed. Manufacturers of Class I devices only need a certificate of product notification rather than the certificate of product approval, although the business license and KGMP certification are still required.
 

Steps to streamline device and drug registration process

On April 1, 2009, the Japanese government decided to bring the "me-too" application category back to its medical device registration system. "Me-too" devices are those that are demonstrated to be equivalent to devices that already have market approval in Japan. The enforcement of the new Pharmaceutical Affairs Law (PAL) in 2005 had abolished the "me-too" category, but the PMDA has decided to reinstate it to facilitate the review process. There are now three tracks for medical device registration applications: one for completely new products, one for improved products, and one for "me-too" products.

Along with the addition of the "me-too" category, the PMDA's medical device review fees also increased on April 1. This fee increase was planned to finance the hiring of more reviewers so that the PMDA can streamline its registration application process. (Please see Volume 9, Issue 3 of the PBM newsletter for more information on the change in fees.)

Device review time should be reduced in the future. In addition to hiring more reviewers in accordance with its action program, the PMDA will also allocate specialized reviewers for each application category by 2011.

Furthermore, the PMDA is streamlining the application document requirements for the "me-too" and improved product categories. The target review time for the "me-too" category is four months. The target review time for the improved products category is ten months for products that require clinical trial data and six months for those that do not.

With respect to drugs, the PMDA now delineates what kind of information will be shared with applicants at each phase of their new drug application (NDA) review. This practice just started in April 2009. For instance, after receipt of the application documents for the NDA, the PMDA will inform the applicant of the schedule for the first meeting with the PMDA, the expected delivery date of the first inquiry from the PMDA, and the current document review order.
 

ASEAN Signs MRA for GMP

On April 10, 2009, the Association of Southeast Asian Nations (ASEAN) Economic Ministers signed the ASEAN Sectoral Mutual Recognition Arrangement (MRA) for Good Manufacturing Practice (GMP). When implemented, GMP certification and inspection reports received in one ASEAN member nation (in accordance with the MRA) will be accepted in all ASEAN countries without requiring additional testing. The MRA also calls for increased harmonization of standards and reduced non-tariff barriers. ASEAN member nations have until 2011 to fully implement the MRA terms.

Upon implementation of the MRA, GMP certificates and inspection reports that are issued in one country will be available to all other ASEAN countries, eliminating repetitive testing and broadening the market potential for drug manufacturers looking to sell in any of the ASEAN countries. This will also facilitate postmarket surveillance and product registration.

Inspections should be done regularly, and member nations will monitor their inspection services to ensure that different countries' standards stay at the same level and that inspectors are able to adequately assess manufacturing facilities.

2008 Medical technology mission
makes it way through China

The contingent of 10 companies and organizations which made up TMTA’s 2008 medical  technology Mission left Canada on April 11. After settling in at the lovely Royal Plaza Hotel and taking a day to explore Hong Kong’s sights and sounds, the group soon headed off to the Science Park. This amazing high technology facility gave everyone a detailed overview of how other countries are involving themselves in research and development in the field of health sciences. The centre also emphasizes what Hong Kong is doing to assist small entrepreneurs in their entry into the vast healthcare market in this part of the world.

Just-in-time hospital
The group was then hosted by the Hong Kong Hospital Authority which operates some 40+ hospitals in the region. The Hospital Authority gave a detailed explanation of how it purchases medical goods and receives them through its network of hospitals. Mission members were assured that the bidding process is wide open and that any company that wishes to bid on tenders issued by the Hospital Authority can do so. Of course, trying to enter this market without first linking up with a local distributor who can service a company’s products would be a serious impediment. This factor is growing in importance as Chinese hospitals switch to just-in-time delivery for all of their needs.

Arriving in Shenzhen
The Mission next headed off to Shenzhen where most stayed at the brand new Futian Sheraton Hotel which is attached to the convention centre in which the China Medical Equipment Fair is located. The first stop in the group’s itinerary was a visit to Shenzhen’s largest hospital. Then it was onto the convention centre where the group participated in setting up the Canadian pavilion which housed all of the individual counters for each participating company. Participating firms included: CardioMed, Edu-Science Ltd, Gowlings, Lafleur and Henderson, IMRIS Inc., NDI Asia Pacific, Pharmax, Phoenix BioMedical, Prime Pacific Health Innovations, Industry Canada and TMTA. 

Heavy traffic at the fair
Traffic at the CMEF was intense and the Canadian Pavilion was constantly flowing as many visitors dropped in to check out our fine choice of products and services. Many visitors also left their business card to enter their name in the Norman Bethune contest. The contest involved giving away more than 100 commemorative T-shirts. Designed by TMTA and sporting slogans in English and Mandarin, the T-shirts featured an authentic 1940’s poster of Dr. Bethune providing medical care to a young child in the midst of a village setting. Honouring Dr. Bethune at the Canadian pavilion was a good fit because his Canadian origin, medical breakthroughs and humanitarian accomplishments are well known all over China. The contest served to increase traffic to the pavilion and raise the profile of the “Canada” brand in the minds of fair attendees.

Many contacts to follow-up on
As the CMEF wrapped up, each firm left Shenzhen with a lot of work ahead of them. All had contacts to follow up on. For several participants, contacts made during the fair are likely to turn into sales in the short term. Some even felt that they had informally sealed deals with distributors and are confident they may soon start offering their products to this huge market.

By April 23, most participants in the Mission had returned to Canada but TMTA chairman Christian and his translator and guide, Anderson Zhen went onto to Beijing to meet with the SFDA and consult with Chinese authorities. Their goal was to find ways of accelerating the licensing process for Canadian manufacturers of medical devices.  Since this meeting with Chinese authorities was considered a government to government exchange, Christian’s visit was spearheaded by Ms. Leah Clark, Director General of Health Sciences at Industry Canada and Mr. George Michaliszyn, Director of the same branch.

Making the case for Canadian businesses
The meeting was cordial and more transparent than the one held with the SFDA last year. The Canadians were reminded that the SFDA has gone through major changes and continues to strive to bring China up to international regulations requirements. Management is aware of the backlog and committed to bringing it under control. But patience will be required on the part of the industry because the massive backlog does not only affect imports. It also impacts a long list of domestic companies requiring certification for their products.

As an official representative of the Canadian government, Ms. Leah Clark made a compelling case for the numerous Canadian companies that waiting to have their products approved. Pointing out that some companies applied up to 4 years ago, she asked for assurances that their products will be approved in a timely fashion. She also stressed that the Government of Canada is ready to assist the SFDA in any way that might improve the situation. Christian Dube also emphasized that several TMTA members have been waiting to get clearance for their products and offered that TMTA would be very willing to offer any assistance which might help.

A massive challenge
The Canadian delegation left the meeting feeling confident that their case had been heard. The SFDA does appear to be quite committed to clear up their backlog. The Director of the SFDA and his assistant formally committed their agency to implement their approval process with all due diligence.  They could certainly use more staff since they presently only have 14 people to process all claims being made.  The task is quite overwhelming.

The weather in Shenzhen had been very hot and humid, "a real killer" according to Christian. Fortunately, the climate in Beijing was somewhat milder and more comfortable. Christian Dube, the Mission’s Head kept members updated with regular postings. Thanks to our new “Spark” communication program, we have also been able to have the occasional real-time conversation with the group as the voyage unfolded.

More details are being shared with TMTA members via this website as reports and photos about the Mission are submitted. Keep checking this page for updates. Background details about TMTA's annual Mission to China can be found on our special promotions page.

Promoting peace through science and technology initiatives

Far resting in anticipation of TMTA's upcoming 4th yearly Mission to China, our intrepid traveling chairman, Christian Dube attended the Canada-Ukraine Business Summit in early March 2008.

Invited to attend the summit by Foreign Affairs and Trade Canada, Christian participated in the 3 day event after landing in Kiev and heading off to Dnipropetrovsk to make a presentation on Canada's Research and Development needs.

The International Science and Technology Centre was the main focus of the summit. The ISTC was formed in 1992 as a non-proliferation program for former countries of the Soviet Union. It coordinates the efforts of numerous governments, international organizations and private sector industries to provide former weapons scientists with new opportunities in international research and development partnerships. The emphasis of ISTC programs is to focus on encouraging commercialization and world-wide application of skills and discoveries which once were exclusively reserved for defense applications. 

As Canada's chosen representative for the medical technology industry, Christian was called upon to elaborate on the needs of Canadian manufacturers for the services of scientists from a wide range of applications from robotics to nanotechnology and almost every other discipline in between.

For additional information about the CIS and the ISTC, click on our global_update  page.