New Medical Device Regulations Challenge or Opportunity?

Since June 1^st, 2014, the newly revised (State Council Decree No. 650, named Regulation as follow) substitutes the former implemented ordinance. The newly revised Regulation is based on the category management and risk management, and classifying the research, manufacturing, distributing and use of medical devices into a unified regulatory framework. The new Regulation controls the permission of medical devices much more strictly, and adding the Good Manufacturing Practices (GMP), re-evaluation of registered medical devices, recall system etc. to strengthen the supervision of medical devices lifecycle. The implementation of new Regulations will promote the development of medical devices industry for sure, but at the same time, what opportunities and challenges it brings to our business?

Opportunity

Generally, the newly revised Regulation would appropriately reduce the pre-market administrative approval, offer the special review for innovative products, simplify review procedures and reduce costs of your company.

a) Class Ⅰ medical devices are no longer required for the pre-market administrative approval. You just need to prepare materials as corresponding requirements, and record your products in the local municipal drug administration department, the record certificate will have its effectiveness permanently, and without the need for the continuation.

b) Class Ⅱ medical devices are no longer required to apply for the distributing certificate. You just need to prepare materials as corresponding requirements, and record your products in the local municipal drug administration department, the record certificate will have its effectiveness permanently, and without the need for the continuation.

c) The medical device registration certificate is now valid for five years instead of four years.

d) CFDA published a clinical trial exemption catalog (draft) and included a number of Class Ⅲ medical products, that is, there will be some Class Ⅲ medical devices can be exempted from clinical trials

e) Establishment applies for the re-registration (or continuous registration) of medical device registration certificate, but CFDA has not yet made a decision in respect of the product continues or not by the expiration day of original registration certificate, then the medical device registration certificate is automatically renewed.

f) The introduction of offers a green channel for a number of innovative products, which allows companies to communicate with center of medical device evaluation (CMDE) in advance, and greatly shorten the period of review and approval procedure but without reduction of evaluation criteria and approval process.

Challenge

While the newly revised Regulation simplifies review procedures, it also strengthens the supervision and administration for products with higher risk simultaneously, and it may put forward higher regulatory requirement on companies.

a) In China, the classification of medical devices is very different from those abroad. According to the newly issued , a large number of products’ classification were adjusted, which leads to the significant difference of classification between domestic products and abroad products , generally, most of domestic products’ classifications are higher than those of abroad products. As a result, materials prepared for registration in original country are much less than those are required in China; therefore, foreign companies those want to conduct registration of their products in China will inevitably encounter the issue of lacking of original materials, which will greatly increase the period and cost of registration.

b) Some Class Ⅰ medical devices were adjusted as Class II medical devices, companies shall refer to Class II medical device supervision requirements when doing the registration, manufacturing, and distributing for these medical devices.

c) CFDA improved the difficulty of medical device registration, even though the Class Ⅰ medical devices become recording system, but CFDA added the requirement of risk assessment, clinical evaluation, manufacturing and research information.

d) Some Class III medical devices with pretty high risk shall acquire the approval before doing clinical trial; CFDA has released the catalogue (draft) of Class III products need to apply for clinical trial pre-review, the formal catalogue will come into force in the near future.

e) When imported products doing the registration, merely products those are listed in can be exempted from clinical trial, all others must conduct the clinical trial in China.

f) China medical device regulations are changing rapidly, but foreign establishments do not understand China regulations very well, while domestic establishments have a weak awareness of regulations; and now, CFDA is going to strengthen the supervision and punishment of medical devices, therefore, companies may face the high penalty of violation.

All in all, how to grasp opportunities and how to deal with challenges under the new situation, it would be a significant question for every company working with medical devices. And in my opinion, “Compliance” shall be the most fundamental factor to be considered in the future development of every enterprise; moreover, every company shall enhance the regulatory awareness, in a timely manner to track regulatory updates, strengthen communication with competent authorities and actively respond to China medical device regulations, thus you can guarantee that your company is with zero risk while meeting challenges under this new situation.

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Mr. Edwin Wen China office
Tel: +86 571 8720 6541 | Fax: +86 571 8720 6533
Email: Edwin.wen@cirs-group.com
Ms. Elaine Lyu Elaine@cirs-group.com