QWP-CDRRHR/LRD-04 Annex 5
Rev. No.00 Date Effective: 30 November 2022
APPLICATION FORM FOR MEDICAL DEVICE NOTIFICATION
TO THE DIRECTOR GENERAL
Food and Drug Administration
Department of Health
ATTN: The Director
Center for Device Regulation, Radiation Health, and Research
Sir/Madam:
In accordance with R.A. 9711 and other related issuance/s, we wish to apply for the (X ) initial ( ) renewal
notification of our product.
APPLICATION FOR MEDICAL DEVICE NOTIFICATION
Device Name: STERILE NEGATIVE PRESSURE WOUND THERAPHY DRESSING KIT
Device Proprietary/Brand Name: RAINHOME
Model/Reference Number/Property Code/Item Code: PU-III
Intended Use of Device:
Intended to be used for negative pressure sealing drainage treatment, suitable for drainage of acute or chronic wounds.
Applicant’s Company Name: P h i l - C h i M e d i c a l E q u i p m e n t & S u p p l i e s C o m p a n y I n c .
Address: 2104 Century Diamond Tower, Century City, Poblacion, Makati City, Metro Manila,
Philippines
LTO No. CD R R H R- N C R - MDI - 1 0 0 8 3 5 7 Validity: J u n e 2 4 , 2 0 2 5
Tel [Link]. No. E-mail address: philchimedicalrph@[Link]
Company President/General Manager: Weicheng Wu
Regulatory Officer: Gene Crosby Marino
Legal Manufacturer (Product Owner): Guangzhou Rainhome Pharm&Tech Co., LTD
Address: Room 201 of 2F, 5F of Building 6, No. 10 Yongsheng Road, Huangpu District, 511356, Guangzhou
City, Guangdong Province, P.R. China
Manufacturing site: Room 201 of 2F, 5F of Building 6, No. 10 Yongsheng Road, Huangpu District, 511356,
Guangzhou City, Guangdong Province, P.R. China
We hereby certify that the foregoing information and all other data submitted in connection with this application
are true and correct. We understand that the failure to report all required information or submission of false or
misleading information is an offense punishable by law. We certify that we have examined the following
statements and we attest to their accuracy:
1. The Current Good Manufacturing Practice/ Quality Management System (ISO) is
applied in full in the manufacture of this product.
2. The manufacturing procedure is exactly as specified in the submitted manufacturing process.
3. The finished product is tested and certified to be fully compliant with the
specifications in the accompanying documentation.
4. The person releasing the product for sale is an authorized and/or qualified person.
5. The procedures for control of the finished product have been validated.
6. The applicant has a standard operating procedure for handling any adverse event
related to the use of the device.
QWP-CDRRHR/LRD-04 Annex 5
Rev. No.00 Date Effective: 30 November 2022
7. The applicant has a standard operating procedure for handling product recalls.
8. All the documentation referred to in this application is available for review during
comprehensive inspection of the establishment.
9. We shall change the brand name so submitted should the proper authority decides with
finality that we have no right to appropriate and utilize the said brand name; and
10. We shall acknowledge and agree to indemnify and/or hold FDA free and harmless
against any and all third party claims arising from the acceptance of such brand name
of the product for registration with FDA.
11. The product covered by this declaration will not undergo any change in the ownership,
registrant’s address/location, manufacturer, ingredients, formulation, size, reference
number, use, manufacturing process (if applicable), labeling or commercial
presentation, and packaging of the product covered by this certificate of notification
without prior approval of this office.
12. We acknowledge and agree that in the event that there is an unauthorized change in the
ownership, its address/location, manufacturer, ingredients, formulation, size, reference
number, use, manufacturing process (if applicable), labeling or commercial
presentation, and packaging of the product:
i. The CDRRHR may automatically suspend the LTO and/or CMDN of the product;
ii. We will voluntarily recall the product from the market; and
iii. We will indemnify and/or hold CDRRHR free and harmless against any and
all third party claims and/or actions pertaining to the above unauthorized
change(s).
13. For abridged application, we attest that all of the product details including the CSDT
technical documentation are exactly the same as the product details and CSDT
technical documentation submitted in the ASEAN counterpart. In the event that there is
an unauthorized change in the product details and CSDT documentation:
i. The CDRRHR may automatically suspend the LTO and/or CMDR of the product;
i. We will voluntarily recall the product from the market; and
ii. We will indemnify and/or hold CDRRHR free and harmless against any and
all third party claims and/or actions pertaining to the above unauthorized
change(s).
Regulatory Officer: Owner/General Manager:
SIGNATURE OVER PRINTED NAME SIGNATURE OVER PRINTED NAME
Government issued ID Number: Government issued ID Number:
Date Issued: Date Issued:
Place of Issuance: Place of Issuance:
SUBSCRIBED AND SWORN before me this day of affiant exhibiting to
me his/her government issued ID Number indicated above.
NOTARY PUBLIC
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