China’s 12th Five-Year Plan outlines three initiatives with respect to medical devices:

• 1. Increase the development of China-made medical equipment.
• 2. Implement centralized procurement
• 3. Purchase domestic medical devices.

The health care reform for the domestic medical device industry provides unprecedented opportunities for Chinese biomedical development.

Compared with foreign medical device companies, Chinese domestic medical firms are still relatively weak. Wei Gao, a Chinese company that manufactures and sells single-use medical devices such as syringes, competes with Becton Dickenson which controls 75 percent of that market in China. For high-end products, foreign companies still account for the majority of the market share.

In 2010, GE, Siemens, Philips, Toshiba, and Neusoft accounted for 92 percent of the domestic market share for CT equipment.

Nevertheless, Chinese medical devices are becoming more sophisticated and more international. More domestically made Chinese medical devices are competing in the Class 3 sector, not just in the Class 1 or 2 sectors. For example, LePu is a Chinese maker of drug eluting stents. In addition to increasing its market share in China, LePu is hoping to sell about 20 percent of their locally-made Chinese products overseas in a few years.

INDIA RECEIVES GOOD LABORATORY PRACTICES CERTIFICATE

In March 2011, India achieved the status of full adherence to Good Laboratory Practices (GLP) certified by the Organization of Economic Cooperation and Development (OECD).

The OECD is composed of the world’s most advanced countries such as the US, the UK, Canada, Australia, etc. This international recognition is a giant leap forward for India in the field of quality compliance. Previously, manufacturers wanting to export pharmaceuticals had to conduct tests overseas. Now, the OECD certificate should help to ensure that the results of chemical safety-tests as well as clinical and non-clinical trials done in India will be accepted in all other 34 member countries. At present, there are 18 GLP-certified facilities in India: 6 of which are pharmaceutical and agrochemical companies, and 12 of which are contract research organizations and government laboratories.

In addition, India has proposed new regulations on clinical trials and Clinical Research Organizations (CROs) in India. Once in effect, some risky medical devices will require local clinical trials in India. These regulations will stress the quality of the clinical trials and the need for more skilled CRO staff. CROs and clinical trials will be more strictly regulated in India to reduce corruption and increase accuracy so they can be used for more global clinical trials and product registration. India’s commitment to cleaner and more transparent clinical and non-clinical trials has made the country a prime location for foreign drug companies.

Additionally, costs for trials in India can be up to 60% less than those in the US. For foreign pharmaceutical companies, there will be an increasing number of clinical trials done in India in the near future.

SINGAPORE: IMPLEMENTATION OF THE FINAL PHASE OF HEALTH PRODUCTS ACT

The Health Products Act (HPA) regulates the manufacture, import, supply, and advertisement of health products in Singapore. Originally passed in November 2007, the HPA is being implemented in phases to minimize the impact on the medical device industry in Singapore.

On May 24, 2011, the Health Sciences Authority (HSA) of Singapore announced the final implementation of Phase 3B of the HPA. Phase 3B deals with the registration of Class A and B medical devices in Singapore. The implementation plans are to go into effect from January 1, 2012 onwards. After this date, the supply and sale of all unregistered medical devices is prohibited.

There are currently four risk classifications of medical devices in Singapore – Class A, B, C, and D. Safer medical devices generally fall into Class A or B, while riskier ones into Class C or D. Mandatory product registration is already implemented for Class C and D devices. After the completion of Phase 3B, product registration of Class A and B products will also be mandatory.

To be in compliance with Singaporean regulations, companies who sell Class A or B medical devices must register their products before Jan. 1, 2012. However, since the registration process can take several months, the HSA recommends that companies currently selling medical products should register before August 31, 2011 to be placed on a transition list. The transition list allows medical device companies in Singapore to sell their products before the official approval is granted.

Companies who register after the August 31st transition list deadline must wait for official product approval before continuing to sell their products in Singapore. In addition, the HSA stipulates that if a medical device product is currently used by consumers but is not currently in the market, product registration is not required. However, the medical device company who made or sold the product must still comply with post-marketing regulations (adverse event reporting, product recalls, etc.).

Ames Gross is president and founder of Pacific Bridge Medical, recognized nationally and internationally as a leader in the Asian medical markets. He founded PBM in 1988 and has helped hundreds of medical companies with business development and regulatory issues in Asia. Ames can be reached at info@pacificbridgemedical.com.