(ICMED) is the first home developed international class certification scheme for the medical devices in the country – is an initiative of Association of Indian Medical Device Industry (AIMED) in collaboration with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB).  

ICMED aims to enhance patient safety, to provide enhanced consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers and users. This Scheme is intended for significantly elimination trading of sub-standard products or devices of doubtful origins, a widespread and injurious phenomenon in the Indian market. 

For manufacturers, it aims to bring down the substantial time and cost-run to obtain globally accepted quality certification for Indian companies and eliminate the malpractices of sub-standard or fraudulent certification or quality audits, thereby ensuring substantial savings, enhanced credibility and increased competitiveness.

The Scheme has been launched with two levels of certification:

• ICMED 9000 certification which is ISO 9001 plus additional requirements;
• ICMED 13485 which is ISO 13485 plus additional requirements.


China’s 13th Five-Year Plan

 One of the key sectors targeted by the Plan is Health and Aged Care. The 13th Five Year Plan promotes the idea of a “Healthy China”, encouraging the participation of the private sector in the establishment of an integrated health and aged care system. Foreign investment is viewed favourably due to its ability to introduce international best practices in to the Chinese market.

The Plan details a number of key targets in the health and aged care space:

• Increase the number of qualified doctors and medical assistants to 2.5 per 1,000 persons;
• Increase the number of general practice doctors to 2 per 10,000 persons;
• Systematically train 500,000 resident doctors to adequate standards;
• Establish 1-2 public hospitals in each county;
• Maintain the proportion of urban and rural citizens with health insurance above 95%;
• Reduce premature mortality from critical chronic diseases by 10%;
• Reduce the infant mortality rate to 7.5%, the mortality rate for children under 5 years to 9.5%; and the mortality rate for childbirth to 18 per 100,000 persons.

Opportunities for international businesses in China

 As China’s demographics alter and its population becomes older and increasingly more urban, China’s growing middle class is beginning to demand higher quality health care. This trend is already generating opportunities for offshore service suppliers, and it is expected more opportunities for international providers offering packaged health, medical and leisure services. Others are likely to take advantage of specific policies, which encourage cross border investment – for example, China’s policy to allow Hong Kong entities to set up wholly-owned hospitals.

 The Plan also promotes the concept of “smart health care”. This covers a wide range of initiatives, including internet-based health information platforms and electronic health records. As expected, China’s demand for various types of technology and innovation in the health sector to increase, presenting a unique opportunity for foreign investors with expertise in advanced medical research and technology to provide system solutions for a growing Chinese market.