Much needed surgery on medical apparatus and instruments regulations

By Cheng Bing, AnJie Law Firm
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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.

程冰 Cheng Bing 安杰律师事务所 合伙人 Partner AnJie Law Firm
程冰
Cheng Bing
安杰律师事务所
合伙人
Partner
AnJie Law Firm

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.

Q: What are the main contents of the amendments to the regulations?

A: The amendments provide the means to resolve problems in the practical operation of the regulations, improving the system for the oversight of medical apparatus and instruments. The major amendments include the following:

  1. Amendment of the definition of the product categories. More clearly demarcates Type 2 and Type 3 medical apparatus and instrument products, and broadens the scope of Type 1 medical apparatus and instruments.
  2. Relaxation of the oversight over medical apparatus and instruments for which the risk is low and the safety high. For Type 1 medical apparatus and instruments, only recordal is required for the products, and no permit or recordal is required for the operation. For dealings in Type 2 medical apparatus and instruments, administration changes from permits to recordal.
  3. Reduction of before-the-fact permissions. Three administrative permissions are directly abolished: approvals for clinical testing of Type 2 medical apparatus and instruments; approvals for the research and manufacture of medical apparatus and instruments by medical institutions; and mandatory safety certification of Type 3 medical apparatus and instruments. Three permissions are changed to recordal: registration of Type 1 medical apparatus and instrument products; registration of non-substantive changes to Type 2 and Type 3 medical apparatus and instruments; and permits for Type 2 medical apparatus and instruments. Finally, the scope of approval for clinical testing of Type 3 medical apparatus and instruments is narrowed.
  4. Increases the responsibility of producers and dealers for product quality control, establishes delivery inspection and sale record systems at the dealing and use stages, and establishes for the first time a recall system for adverse events involving medical apparatus and instruments.
  5. Strengthens oversight, improves relevant legal liability, intensifies penalties for violations of laws and regulations, and enhances the deterrent effect of the law.

Q: What is the significance of amending the regulations?

A: The amendment is significant. With respect to the versions of the regulations before and after, the amended regulations will have the following effect once implemented:

  1. The administrative approval procedures for the medical apparatus and instrument industry will be faster, reducing the costs of enterprises and the public, economising regulatory resources and enhancing regulatory efficiency.
  2. Will stimulate the research and development of innovative medical apparatus and instruments, promoting industrial upgrading and the shakeout of mediocre producers in the medical apparatus and instrument industry.
  3. Will further regulate the production of medical apparatus and instruments, which will be conducive to ensuring the safety of the public when using the apparatus and instruments, and the traceability of liability for medical apparatus and instrument products.

Q: What issues will medical apparatus and instrument producers have to focus on following the amendments?

A: First, for such producers and dealers, in addition to being required to satisfy the pertinent hardware conditions – e.g. place of production or operation, environmental conditions, etc. – they will be required to attach importance to improving their software level, e.g. improving quality management systems, after-sales service capabilities, delivery inspection record systems, etc.

Second, the producers have to pay attention to whether their entire production process complies with the requirements of laws and regulations, and to monitor usage of their medical apparatus and instruments, and conduct regular self-inspections in accordance with the requirements of laws and regulations to ensure the safety and efficacy of their medical apparatus and instruments.

Cheng Bing is a partner at AnJie Law Firm

(AnJie Law Firm)

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chengbing@anjielaw.com

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