Decree 29 Measures For The Administration Of Medical Device Recall

Order of the China Food and Drug Administration (No. 29)
The Measures for the Administration of Medical Device Recalls, as deliberated and adopted at the
executive meeting of the China Food and Drug Administration (“CFDA”) on January 5, 2017, is hereby
issued, and shall come into force on May 1, 2017.
Director: Bi Jingquan
January 25, 2017
Measures for the Administration of Medical Device Recall
Chapter I General Provisions
Article 1 In order to strengthen the supervision and administration of medical devices, control defective
medical device products, eliminate the hidden safety risks of medical devices, ensure the safety and
effectiveness of medical devices, and protect human health and life safety, these Measures are
developed in accordance with the Regulation on the Supervision and Administration of Medical Devices.
Article 2 These Measures shall apply to the recall of medical devices that have been sold within the
territory of the People’s Republic of China and the supervision and administration thereof.
Article 3 For the purpose of these Measures, “medical device recall” means a medical device production
enterprise’s act of handling defective medical device products of certain categories, models or batches
which have been sold through warning, inspection, repair, re-labeling, modification and improvement of
instructions, software updating, replacement, recovery or destruction or other methods under the
prescribed procedures.
“Medical device manufacturers” as mentioned in the preceding paragraph means the applicants for the
registration or recordation of medical devices within the territory of China and the agents designated by
the overseas manufacturers of imported medical devices within the territory of China.
Article 4 For the purpose of these Measures, “defective medical device products” shall include:
(1) products which have unreasonable risks that may endanger human health and life safety under the
circumstances of normal use;
(2) products that do not comply the compulsory standards or the technical requirements for products
that have been registered or undergone recordation formalities;
(3) products that may have unreasonable risks due to their failure to comply with the relevant
provisions on medical device production and operation quality management; and
(4) other products that need to be recalled.
Article 5 Medical device manufacturers are the parties responsible for the control and elimination of
product defects and shall take the initiative to recall defective products.