Much needed surgery on medical apparatus and instruments regulations

The amended version of the Regulations for the Oversight of Medical Apparatus and Instruments was adopted at the 39th executive meeting of the State Council and took effect on 1 June 2014. The intent of the amended regulations is “to establish the strictest regulatory system covering the entire process”, providing a sound legal basis for the oversight of medical apparatus and instruments.

Q: What is the background to, and reasons for, amending the regulations?

A: In recent years, the development of the localised medical apparatus and instrument industry in China has been rapid, with the level of production greatly improving. Numerous problems had arisen in practice under the regulations, and they had begun to hamper the development of enterprises and the upgrading of products, making it impossible to effectively maintain an orderly competitive environment in the medical apparatus and instrument industry. This is the main reason for the amendments. The main problems existing in the regulations included the following:

1. A discrepancy in the classification of medical apparatus and instrument products with that of developed countries, and one that was also divorced from medical practice in China. For example, in China, all medical implants, regardless of the history of their use, the location of their implantation or their safety factor, were classified as Type 3 apparatus. This made the entry threshold for enterprises that produce low and medium-end implants too high, discouraging the entry of new competitors and hurting market competition.
2. Product registration requirements were excessive, registration times too long and the terms of effectiveness relatively short. These were not only a burden on enterprises but also a burden on the approval work of the food and drug authorities, one of the important reasons why the registration period for medical apparatus and instruments is relatively long.
3. The emphasis of the oversight of medical apparatus and instruments was on pre-market oversight, with a lack of oversight measures for the post-market use of the products and administration.
4. The effect of the regulations on stimulating innovation in medical apparatus and instruments was relatively weak, hampering the research and development of innovative medical apparatus and instruments in China.
5. The provisions on legal liability of the regulations were not sufficiently specific or clear, lacking effective and sufficient intensity and basis for cracking down on and punishing certain violations of laws and regulations that accompanied the development of the medical apparatus and instrument industry in recent years.

Cheng Bing is a partner at AnJie Law Firm