Announcement
of Relevant Issues on Implementing Provisions
for Medical Device Manufacture and Provisions for Medical Device Distribution
by CFDA
SYJXJ No. 143 [2014]
Issued on August 1, 2014
All
food and drug regulatory authorities of the provinces, autonomous regions and
municipalities directly under the central government:
Provisions for Medical Device
Manufacture (CFDA Decree No. 7) (hereinafter referred to as
“Manufacture Provisions”) and Provisions for Medical Device Distribution (CFDA Decree No. 8) (hereinafter referred to
as “Distribution Provisions”)
have been issued and shall come into force as of October 1, 2014. Relevant
issues are hereby announced as follows:
-
The food and drug regulatory authorities
at all levels shall strengthen the publicity and training of Manufacture
Provisions and Distribution Provisions so as to deeply understand, proficiently
master and assiduously implement them in combination with the actual situation of
all administrative regions.
-
From October 1, 2014, the application
for Manufacture Certificate and filing of new medical device manufacturers
shall be carried out in accordance with relevant regulations in Manufacture
Provisions. Application
for Manufacture Certificate of new medical device manufacturers which has been
accepted but not approved prior to October 1, 2014 shall be carried out in
accordance with relevant regulations in Manufacture Provisions after the
implementation of Manufacture Provisions.
-
Existing Manufacture Certificate for
Medical Device remains effective within its validity. After the implementation
of Manufacture Provisions, the application for change, renewal and reissuance
of the certificate shall be reviewed in accordance with relevant regulations in
Manufacture Provisions. On-site inspection may be carried out if necessary.
Those complying with the specified requirements shall be granted to new
Manufacture Certificate for Medical Device with its validity starting from the
issuing date. If
registration of Class I medical device has been conducted, manufactures shall
apply for the filing of Class I medical device with the food and drug regulatory
authority of the municipality consisting of districts where the
enterprise is located in accordance with relevant regulations in Manufacture
Provisions prior to March 31, 2015.
-
For manufacturers of which the
registration and filing of commissioned manufacturing of Class II and Class III
medical devices has been conducted, if the Manufacture
Certificate for Medical Device of either party is expired or there is
change, renewal and reissuance occurred after the implementation of Manufacture
Provisions, original registration and filing of commissioned manufacturing
shall be terminated. For manufacturers who need to continue commissioned
manufacturing, relevant procedures shall be gone through in accordance with the
relevant regulations in Manufacture Provisions. Manufacturers
with the registration and filing of commissioned manufacturing of Class I
medical devices conducted shall go through relevant procedures in accordance
with relevant regulations in Manufacture Provisions when the continuing
commissioned manufacturing is in need since the original one being terminated
on March 31, 2015.
-
Manufacturers with manufacture sites
established cross the provinces shall continue manufacturing until the expiry
date of Manufacture Certificate for
Medical Device. If continuing manufacturing is needed after the expiration
of the certificate, manufacturers shall apply for Manufacture Certificate
separately with the food and drug regulatory authorities at provincial level
where the enterprise is located in accordance with relevant regulations in
Manufacture Provisions. Manufacturer
with manufacture sites established cross the municipality consisting of
districts in the Registration Form for
Class I Medical Device Manufacturers shall continue manufacturing until
March 31, 2015. If continuing manufacturing is needed after the expiration of
the form, manufacturers shall apply for the filing of Class I medical devices
separately with the food and drug regulatory authority of the municipality
consisting of districts where the enterprise is located in accordance with
relevant regulations in Manufacture Provisions.
-
The manufacturers of export medical
devices shall file relevant information of export products with the food and
drug regulatory authority of the municipality consisting of districts where the
enterprise is located. Relevant information includes export products,
manufacturers, export enterprises, countries (regions) sold in as well as
whether it is commissioned manufacturing by overseas enterprises.
-
From October 1, 2014, Distribution
Certificate and filing of new medical device manufacturer shall be carried out
in accordance with relevant regulations in Distribution Provisions. Application
for Distribution Certificate of new medical device manufacturers which has been
accepted but not approved prior to October 1, 2014 shall be carried out in
accordance with relevant regulations in Distribution Provisions after the
implementation of Distribution Provisions.
-
Distribution Certificate for Medical
Device of existing medical device distributors remains effective within its validity.
After the implementation of Distribution Provisions, the change, renewal and
reissuance application from medical device distributors involving distribution
of Class III medical devices shall be reviewed in accordance with relevant
regulations in Distribution Provisions. On-site inspection may be carried out
if necessary. Those complying with the specified regulations shall be granted
to new Distribution Certificate for Medical Device with its validity starting
from the issuing date.
-
Manufacture Provisions, Distribution
Provisions and relevant forms involved in this announcement are attached as
annexes.
-
From the implementation date of
Manufacture Provisions and Distribution Provisions, where the requirements are
inconsistent with those in this announcement, the requirements in this
announcement shall be implemented. Relevant problems encountered in the work
shall be timely feed back to CFDA.
Attachment:
1. Manufacture Certificate for Medical
Device (template) and its specification accreditation
2. Application Form for Manufacture
Certificate for Medical Device (template)
3. Application Form for Changes of
Manufacture Certificate for Medical Device (template)
4. Application Form for Renewal of
Manufacture Certificate for Medical Device (template)
5. Application Form for Reissuance of
Manufacture Certificate for Medical Device (template)
6. Application Form for Cancellation of
Manufacture Certificate for Medical Device (template)
7. Filing Form for Class I Medical Device
Manufacture (template)
8. Filing Certificate for Class I Medical
Device Manufacture (template)
9. Filing Form for Changes of Class I
Medical Device Manufacture (template)
10. Filing
Certificate Form for Reissuance of Class I Medical Device Manufacture
(template)
11.
Filing Form for Commissioned Manufacture
of Medical Devices (template)
12.
Filing Certificate for Commissioned
Manufacture of Medical Devices (template)
13.
Export Filing Form for Medical Devices
(template)
14.
Distribution Certificate for Medical
Device (sample) and its specification accreditation
15.
Application Form for Distribution
Certificate for Medical Device (template)
16.
Application Form for Changes of
Distribution Certificate for Medical Device (template)
17.
Application Form for Renewal of
Distribution Certificate for Medical Device (template)
18.
Application Form for Reissuance of
Distribution Certificate for Medical Device (template)
19.
Application Form for Cancellation of
Distribution Certificate for Medical Device (template)
20.
Filing Form for Class II Medical Device
Distribution (template)
21.
Filing Certificate for Class II Medical
Device Distribution (template)
22.
Filing Form for Changes of Class II
Medical Device Distribution (template)
23.
Filing Certificate Form for Reissuance
of Class II Medical Device Distribution (template)
China Food and Drug Administration
August 1, 2014
Annex
of SYJXJ No. 143 [2014]
