Data Sheet and Checklist for Domestic/Imported Class II and III Medical Devices

Precautions: (Starting May 2017)

1. Please submit all required documents and complete this sheet when applying. The documents shall be arranged
according to the checklist and labeled with tags, in order to facilitate initial screening.
2. Documents for the registration of medical devices must meet the Regulation for Registration of Medical Devices.
3. A backup of the application materials shall be prepared in advance, and the seals of the pharmaceutical company as well
as the responsible person must be kept consistent.
4. Items marked with a "★" do not need to be enclosed again when preparing the materials for review by the medical
device advisory committee . Please use two-sided printing for documents submitted for registration of medical devices.
Product Name Product
Applicati (Chinese) Category
on No. Product Name
(English)
□ Class 2; □ Simplified review (applicable Self-check Results of Initial
only to Class 2 with predicted medical Screening
devices; when this is checked, the * Please insert a "" in (to be filled in by the
Product Class
documents listed in Section 15 may be the “Yes” box if reviewers)
waived) applicable
□ Class 3 ; submitted in STED format *Please put a "" in
 No predicted medical □ Yes (When checked, documents listed in the box if not
devices Sections 15, 16, and 17 must also be applicable, and
provided) specify reason(s) in
□ No (when checked, documents listed in the remarks column
Sections 16 and 17 may be waived)
Materials to be attached Document No. Yes Remarks Yes Remarks
I. Background Description Relevant background information: 1.1 * This section is not
(Not required if not Please note the prior application number and □ included in the items
available) provide a copy of the official document(s) for for initial screening
non-first-time applications: 1.1.1
If there are other relevant applications at the
same time, please note the application
numbers and provide a copy of the application □
form: 1.1.2
Please provide the information if the products □
have been received consultation from the
TFDA 1.1.3
Please provide the information if the products □
have been received consultation from relevant
foundations: 1.1.4
II. Application Form for Application form: 2.1
Medical Devices ---One original and one photocopy of the □ □
Registration application form with the seals of the
(One original and one pharmaceutical company and the responsible
photocopy of the person
application form shall ---States the Chinese and English product □ □
both be typed in English names
and in Chinese, and filled ---States the name and address of the □ □
out according to the pharmaceutical company, which shall be
submitted documents) consistent with those shown in the
Pharmaceutical Company License for
manufacturers or the Pharmaceutical
Company License for distributors.
---States manufacturer's name and address □ □
---States the name and address of the sponsor □ □
and contract manufacturer; if it is applicable,
it must be listed
III. Essential Principles and Application for Class 3 medical device □ □ * Only the
Summary of Technical registration shall meet the Essential Principles presence or
Documentation Summary of Technical Documentation absence of the
announced by TFDA: 3.1 documents will
be examined
IV. Medical devices The CCC Codes shall be specified for devices □ □
imported from Mainland that are not stipulated as restricted products
China★ (MP1, MW0) by the Bureau of Foreign Trade
(BOFT); an import permit issued by the BOFT
shall be attached for products that are subject
to import restrictions: 4.1
V. A photocopy of the Pharmaceutical Company License for □ □
Pharmaceutical manufacturers of medical devices: 5.1
Company License for Pharmaceutical Company License for
manufacturers/distributo distributors of medical devices: 5.2.1 □ □
rs of medical devices★ For contract manufacturing products, a
photocopy of the Pharmaceutical Company □
License for distributors shall also be attached:
5.2.2 □
VI. Affidavit (Party A)★ Affidavit: 6.1
---Shall be the original copy with the seals of □ □
the pharmaceutical company and the
responsible person
---The format of the Affidavit shall be of the □ □
latest version
---Relevant information and the seals of the □ □
pharmaceutical company and the responsible
person shall be consistent with those provided
in the application form
---States the declaration date □ □
VII. Free Sale Certificate The FSC issued in the country of origin: 7.1
(FSC) of the country of ---Shall be the original copy (the application □ □
origin★ number of the original copy shall be
specified or description that the original
copy is certifying by the ROC
representative office if a photocopy is
submitted)
---Issued by the highest health authority of the □ □
country of origin, and certified by the ROC
Representative Office in the country (if the
original copy is undergoing certification, a
photocopy may be enclosed)
---States that the product is manufactured and □ □
marketed in the country of origin
---Valid for two years from the date of □ □
issuance
---States the manufacturer's name and address, □ □
which shall be consistent with those
provided in the application form
---For certificates not issued in English, a □ □
translation in Chinese or English shall be
provided
---States the name and model (specification) □ * This issue is not
of the product included in the items
for initial screening
VIII. The Letter of The LOA issued by the manufacturer:8.1
Authorization (LOA) ---Shall be the original copy (the application □ □
issued by the number of the original copy shall be
manufacturer ★ specified if a photocopy is submitted)
---Issued by the manufacturer; valid for one □ □
year from the date of issuance
---States the manufacturer's name and address, □ □
which shall be consistent with those
provided in the application form
---States that the product is authorized for □ □
registration
---States that the name and model of the □ * This issue is not
product (or all products) are authorized for included in the items
registration for initial screening
review
IX. Documents relevant to Contract manufacturing agreement: 9.1
contract manufacturing ---Shall be signed by both parties □ □
agreement★ ---States the name and address of the sponsor □ □
and contract manufacturer; information must
be consistent with the application form
---States the name and model (specification) □ * This issue is not
of the product, and must be valid within the included in the items
effective period for initial screening
review
X. Good Manufacturing cGMP/QSD compliance letter: 10.1
Practice (GMP)/Quality ---A photocopy of the GMP/QSD compliance, □ □
System Documentation or provide the application number
(QSD) compliance letter ---The certified pharmaceutical company must □ □
★ be consistent with the applicant who
(Proceed in accordance submits the application for registration
with the Regulations of ---If the certified pharmaceutical company is □ □
Medicament different from the applicant who submits
Manufacturer Inspection) the application for registration, the
authorization letter issued to the
pharmaceutical company, as well as the
Approval and Registration Certificate and
the authorization letter issued by the
original manufacturer, must be submitted
---The manufacturer's name and address listed □ □
must be consistent with that on the
application form
---Valid for three years from the date of □ □
registration
---The specified item must be in the same □ * This issue is not
category as the product being applied for included in the items
for initial screening
XI. Label attachment Two copies of the package and the label (must □ □ * Only the
including affixed or clearly specify the date of manufacture and presence or
stapled instructions for effective period or expiration date): 11.1 absence of the
 use (Chinese), packaging Two copies of the original package insert □ documents will
and labels contents and their instructions for use in be examined
(Package insert draft Chinese: 11.2
can be written with Two copies of color pictures of the product: □
reference to the 11.3
"Principles for Editing The original package insert contents: 11.4 □
Medical Device The original instructions for use: 11.5 □
Instructions”)
XII. Relevant documents List relevant background information: 12.1 □ * Only the
concerning product The product background description shall □ presence or
structure, materials, contain the time and the country where the absence of the
specifications, product was sold on the market for the first documents will
performance, intended time, the manufacturer's name and address, be examined
uses, drawings, etc. and model number: 12.1.1
However, for If the manufacturer's name, address or model □
instruments, an has changed during the period, please explain
operation manual or a the reason(s) for change and provide a
service manual that before-and-after comparison document: 12.1.2
covers all of the If a previous generation of the product is □
above-mentioned available, the difference between the previous
information may be generation and current product must be
replaced explained: 12.1.3
Product structure, materials, performance and □
other relevant information and specific safety
requirements: 12.2
Certificates for raw materials of cattle or □
sheep origin, explanation of the source(s) of
animal tissues, extraction processes for raw
materials, description of the manufacturing
processes and raw material control process,
and relevant certificates or documentation
shall be attached: 12.2.1
If materials for products with high risk of □
exposure contain PVC and DEHP is used as a
plasticizer, evaluation reports on the limits of
dissolved DEHP and risk assessment shall be
provided: 12.2.2
Original operation manual: 12.3 □
Original maintenance and repair instructions: □
12.4
XIII. Information on similar Comparison documents for similar or related □ □ * Only the
or related products products (including the previous generation presence or
that have been product) that have been approved by the absence of the
approved by the MOHW and relevant information. documents will
MOHW (including Equivalence comparison for the product and be examined
license number, marketed medical devices shall be attached;
package insert, for the contents, please refer to the
indications and “Determination Process Flow for Similar
specifications Medical Device” announced by the
comparison Department of Health on August 18, 2010:
documents) 13.1
XIV. Marketing status in One original certificate for marketing □ □ * Included in
other countries authorization issued by USFDA: 14.1 the items for
(One original One original certificate for marketing □ initial
certificate of market authorization issued by the government or screening only
approval issued by the other competent authorities in any EU if the
government of the member state: 14.2 manufacturer
USA and by the checks the box
government or other for US and EU
competent authorities expedited
of any EU member application.
state can be used to Only the
replace the manufacturer's
information requested name/address
in Section 15, if the will be
medical device is reviewed to
Class II with similar ensure that the
products marketed in information is
Taiwan) consistent
with the
application
form
One original certificate for marketing □ * This issue is not
authorization issued by the highest official included in the items
competent health authority in other for initial screening
regions/countries out of USA and EU: 14.3 review
XV. Acceptance criteria, List preclinical testing acceptance criteria, * Please note if
test methods and methods, and the original test records: not applicable.
records of The following tests shall be enclosed as
preclinical tests and required by product character
product quality ---Electrical safety □ □
control report ---Electromagnetic compatibility □ □
conducted by ---Sterilization validation and release □ □
manufacturer ---Biocompatibility □ □
(One copy each, ---Software validation □ □
required for all ---Functional tests (e.g. physical, chemical, □ □
products) and mechanical)
(Laboratories that are ---Others (testing focusing on product □ □
commissioned to properties)
perform * Please note test reports following the
biocompatibility, numeration method below
electrical safety, 15A.1: XXX test data
electromagnetic 15A.1.1
compatibility, and …
sterility tests shall 15A.2: XXX test data
meet one of the 15A.3: XXX test data
 following The acceptance and method for final product □ □ * Only the
requirements: 1. inspection: 15B.1 presence or
Compliance with the The test records and test reports: 15B.2 □ absence of the
stipulations of documents will
ISO/IEC 17025; 2. be examined
Compliance with
ISO/IEC17025 or
regulations of Good
Laboratory Practice
(GLP)
XVI. Scientific theory List research reports and data of this product: □ * This section is not
and relevant 16A.1 included in the items
research reports and List research reports and data of similar □ for initial screening
data products: 16B.1
(If published papers
are provided, the
source, title and date
of publication of the
reference(s) shall be
listed)
(Submission of the
reports is waived if
similar products are
available)
XVII. Clinical trial reports List clinical trial reports relevant to this □ * This section is not
(If published papers product: 17A.1 included in the items
 are provided, the List supporting evidence and clinical trial □ for initial screening
source, title and date reports thereof for similar products: 17B.1
of publication of the List clinical trials that are conducted □
reference(s) shall be domestically: 17C.1
listed) List clinical trial information approved by the □
(Submission of the US FDA or the EU: 17D.1
reports is waived if Other: 17E.1 □
similar products are
available)
XVIII. Radiation Radiation protection and safety information: □ * This section is not
protection and 18.1 included in the items
safety information for initial screening
for devices capable
of producing
ionizing radiation
(Two copies each.
The information for
radiation safety
review shall meet the
requirements of the
Atomic Energy
Council's regulations;
refer to the Atomic
Energy Council's
website
http://adr.doh.gov.tw
for details)