Công văn 7395/BYT-TB-CT năm 2020 về hồ sơ đăng ký lưu hành trang thiết bị y tế do Bộ Y tế ban hành

To: Applicants for medical device registration
(hereinafter referred to as “applicants”)

Pursuant to the Government’s Decree No. 36/2016/ND-CP dated 15/5/2016 on medical device management (hereinafter referred to as “Decree No. 36/2016/ND-CP”), the Government’s Decree No. 169/2018/ND-CP dated 31/12/2018 amending some Articles of Decree No. 36/2016/ND-CP (hereinafter referred to as “Decree No. 169/2018/ND-CP”), the Government’s Decree No. 03/2020/ND-CP dated 01/01/2020 amending Article 68 of Decree No. 36/2016/ND-CP (hereinafter referred to as “Decree No. 03/2020/ND-CP”), and Circular No. 46/2017/TT-BYT dated 15/12/2017 by the Minister of Health on guidelines for Decree No. 36/2016/ND-CP (herein after referred to as “Circular No. 46/2017/TT-BYT”).

Recently, the Ministry of Health has received, processed and appraised applications for medical device registration (hereinafter referred to as “registration applications”) and provided Official Dispatches and guidelines to assist you with preparing these applications according to regulations.

In order for you to understand and comply with regulations properly and accelerate appraisal of registration applications according to regulations of Decree No. 36/2016/ND-CP, Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP, the Ministry of Health would like to request you to perform the following tasks:

1. Regularly check your accounts and email addresses to follow the application appraisal process on the online public service system for medical device management (hereinafter referred to as “online public service system”).

2. Study regulations in Article 25 and Article 26 of Decree No. 36/2016/ND-CP and Decree No. 169/2018/ND-CP and instructions of use uploaded onto the online public service system to submit the appropriate application following the correct procedure.

Ex: apply for registration of a medical device without applicable national technical regulations following the procedure for medical devices with national technical regulations; submit an ineligible application following the procedure for quick issuance of registration number.

3. Review compliance of components of your applications such as ISO certificate, certificate of free sale, letter of authorization, etc. submitted to the online public service system with regulations in Articles 26 and 28 of Decree No. 36/2016/ND-CP and Decree No. 169/2018/ND-CP to prepare to update expired documents at the request of application appraisal specialists.

4. For certificate of conformity with ISO 13485 standard per regulations in Clause 1 Article 68 of Decree No. 36/2016/ND-CP and Decree No. 169/2018/ND-CP:

- The scope written on the certificate must specify the medical device applying for registration number. E.g., the scope of the certificate included in an application for registration of an ultrasound machine must specify the factory manufacturing the machine.

- ISO 13485 certifying bodies operating in Vietnam must comply with regulations in the Government’s Decree No. 107/2016/ND-CP dated 01/7/2016 prescribing conditions for provision of conformity assessment services, and have their names and scopes of service published on the web portal of Directorate for Standards, Metrology and Quality - Ministry of Science and Technology.

5. Regulations on supplement to registration applications:

a) Review your registration applications on the online public service system and comply with regulations in Article 29 of Decree No. 36/2016/ND-CP and Decree No. 169/2018/ND-CP: if you fail to revise your applications within 90 days starting from the date upon which the Ministry of Health requests you to do so in writing or your applications are still unsatisfactory after 05 supplementation times, the registration procedures will be restarted.

b) Remove registration applications that you no longer wish to be considered or are unable to complete.

6. Regarding medical device classification form: review your medical device classification forms and ensure that these forms are published on the web portal of the Ministry of Health according to regulations in Point c Clause 5 Article 66 of Decree No. 36/2016/ND-CP and Decree No. 169/2018/ND-CP, excluding classification results included in registration applications submitted prior to 01/9/2019 according to regulations in Circular No. 42/2016/TT-BYT dated 15/11/2016 by the Ministry of Health.

7. Study regulations on grouping of medical devices in Circular No. 39/2016/TT-BYT dated 28/10/2016 by the Ministry of Health on classification of medical devices when preparing registration applications to minimize number of applications and reduce pressure of application appraisal on the competent authority.

8. Declare information in your registration applications following the guidance provided in Appendix I (attached document).

Any difficulty arising during registration application submission should be reported to the Ministry of Health (Department of Medical Equipment and Construction), phone number: 024.62732272, email: dmec@moh.gov.vn for consideration and guidance on resolution.

For your reference and compliance./.

APPENDIX I

SOME GUIDELINES ON DECLARATION OF INFORMATION IN APPLICATIONS FOR MEDICAL DEVICE REGISTRATION

1. Applications for new registration number:

a) Declare full and accurate information on the applicant’s name (including tax identification number, address, phone number and email) and information on the applicant’s legal representative as written on the enterprise certificate/ investment certificate.

b) Name of medical device:

- Declare information in Vietnamese and lowercase (no capitalization, no English name, commercial name, brand name, code or type or combination of names of multiple medical devices).

- The device’s name is appropriate to its medical use as follows:

+ Names of in-vitro diagnostic medical devices must include the following information:

1. Product type: reagent/ calibrator/ control/ kit/ test tray/ test strip/ electrode/ card.

2. Test type: qualitative/ quantitative/ semi-quantitative.

3. Analytical parameters/ analyte.

In addition, there are some support products such as in-vitro diagnostic medical devices for lysis-based testing; in-vitro diagnostic medical devices for fluorescence testing, etc.

E.g., incorrect name: “Chemical_diagnosis_HIV => correct name: HIV qualitative reagent; incorrect name: Immuno testing chemical_for testing_syphilis => correct name: Treponema pallidum qualitative reagent; incorrect name: Chemical_detection_ SARS-CoV-2 IgG antibodies =>  correct name: SARS-CoV-2 IgG antibodies qualitative test kit.

+ For medical devices besides in-vitro diagnostic medical devices: e.g., incorrect name: Guide wire => correct name: Guide wire used for cardiovascular intervention; incorrect name: Medical material used in dentistry => correct name: Dental implant.

- For applications for registration of a medical device as a part of a kit/ cluster/ group/ family/ system, the medical device’s name must abide by rules for grouping of medical devices in Circular No. 39/2016/TT-BYT dated 28/10/2016 by the Ministry of Health on classification of medical devices.

c) Type:

- Declare information written on the certificate of free sale in an adequate and accurate manner and do not write the name of the medical device in the type field.

- For applications for registration of medical devices of different types and product codes, list the types based on product code and packaging specification (if any).

- Declare the class of medical devices of classs B, C and D in a correct manner based on medical device classification forms the results of which have been published on the online public service system by facilities eligible for medical device classification. The medical device classification form must specify whether a medical device is registered as a part of a kit/ cluster/ group/ family/ system.

d) The country/ies in addresses of the manufacturing facility, warranty service providers, medical device owner and applicant shall be written in a consistent manner.

e) Name of manufacturing facility and address of manufacturing facility: declare full and accurate information as written on the certificate of conformity with ISO 13485 standard or certificate of free sale of imported product.

g) Information on product owner: declare full and accurate information as written on the certificate of free sale of imported product.

2. Catalogues:

a) For applications for registration of medical devices besides in-vitro diagnostic medical devices domestically manufactured: applicants shall provide the documents mentioned in Article 26 of Decree No. 36/2016/ND-CP and Decree No. 169/2018/ND-CP, and study and adhere to regulations of Decree No. 46/2017/TT-BYT.

b) For applications for registration of a medical device as a part of a kit/ cluster/ group/ family/ system: applicants shall provide a separate catalogue for each product type or one consolidated catalogue with reference or link to the page/section corresponding to each product type.

c) Catalogues shall include full information and not refer to other documents (e.g., do not write “Refer to attached instructions for use”), unless the information could not be summarized or is too long (e.g., preclinical, clinical, manufacturing process, etc. sections). If a catalogue has multiple appendixes, each part shall have a heading and table of contents.

3. Instructions for use in Vietnamese:

Instructions for use shall include the following basic information: intended purposes/ indications, contraindications (if any), warnings, precautions, adverse effects (if any), administration, information on diagnostic efficiency for in-vitro diagnostic medical devices and storage conditions and use conditions necessary for maintenance of safety and effectiveness of medical devices.

4. Label specimens:

a) Labels shall adhere to regulations of the Government's Decree No. 43/2017/ND-CP dated 14/4/2017 on goods labels.

b) For original labels: specimens of labels of every product type and packaging specification, including container labels, secondary container labels, etc., shall be provided. In case of application for registration of a medical device as a part of a family, applicants may submit the common label used for the whole family and specify which information on the label is replaceable.

5. Attached files:

a) Scan documents included in your applications in color. All pages of notarized copies shall be scanned with the notary seal stamped on each page or over the fanned edges of the pages.

b) Add all scanned pages of a document into one file in the correct order and name the file according to the document’s content. E.g., certificate of free sale, certificate of conformity with ISO 13485 standard, letter of authorization, etc.

c) If the certificate of free sale has multiple pages, scan all pages and mark which product is applying for registration number.

d) Do not upload files irrelevant to your registration applications.

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