Major Changes in Medical Device Regulations in China Affecting Market Access

The revised Regulation on the Supervision and Administration of Medical Devices, endorsed by Chinese Premier Li Keqiang, was published on March 31th, 2014, and it will come into effect on June 1st, 2014. (Below we call it “Order 650”, ex-Order 276).

There are 5 key sub-regulations, including the Provision on Medical Device Registration which have been published by CFDA calling for comments by April 30th, 2014. They are:

  • a) Provision on Medical Device Registration (current decree #16)
  • b) Provision on In-Vitro Diagnostic Products Registration (current CFDA [2007]229?)
  • c) Provision on Instruction for Use and Labeling (current decree #10)
  • d) Clinical Trial Exemption List for Class II Medical Devices
  • e) Clinical Trial Exemption List for Class III Medical Devices For medical devices manufacturers, below Eight Critical

Changes should be noted:

  1. Class I medical devices, no registration is required any more, only to be put on record at CFDA (imported) or Provincial FDA (China domestic).
  2. Clinical Trial Requirements, foreign companies and domestic companies are equally treated. Clinical trial in China will required for Class II and Class III products registration. CFDA will issue the exemption lists for some Class II&III products.
  3. Manufacturing license will be required after products registration, in the past, it was the other way around.
  4. Submission Dossier will be more harmonized with international requirements, for instance, referring to STED (Summary Technical Document) from GHTF.
  5. Country of Origin approval will be required before the product is registered in China (this wasn’t the case in the past).
  6. Product registration is valid for 5 years instead of 4 years.
  7. Product Changes registration, differentiation will be made depending on whether the changes are significant or not. Registration access through either approval process or record process will be done..
  8. Registration is no longer free of charge, may be 10,000-100,000 RMB per registration application.

COCIR is intensively working with MITA, CAMDI (China Association for Medical Device Industry) and other Associations from US and Japan, in order to have group discussion to the draft regulations, to collect input from members, and to consolidate industry comments and suggestions to CFDA. CFDA assigned CAMDI to take industry lead in China to collect comments by end of April, 2014.

Although COCIR welcome the simplified registration process for Class I products and some minor changes; and submission dossier to refer to international guidance such as STED from GHTF, we remain concerned with the new requirements for clinical trial to be performed in China, and additional tests, such as EMC tests.