Chương IX Nghị định 96/2023/NĐ-CP: Điều khoản thi hành

Chapter IX

IMPLEMENTATION

Article 147. Effect

1. This Decree comes into force from January 01, 2024.

2. Provisions on updating and publishing of information on the healthcare management information system in this Decree shall apply from January 01, 2027.

3. The Government’s Decree No. 109/2016/ND-CP dated July 01, 2016 prescribing issuance of practicing certificates to medical practitioners and issuance of operating licenses to health facilities and Article 11 of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 providing amendments to regulations on business conditions under state management of the Ministry of Health of Vietnam shall cease to have effect from the effective date of this Decree.

4. Health facilities may make payment of healthcare costs according to regulations promulgated or approved by competent authorities until new regulations are promulgated but not later than December 31, 2024.

Health facilities that are issued with operating licenses within the period specified in clause 4 of this Article may apply regulations on classification to payment of healthcare services covered by the health insurance fund in accordance with regulations of law on health insurance.

5. Administrative procedures prescribed in this Decree shall be followed directly, by post or online in accordance with regulations of law on online completion of administrative procedures when relevant conditions are met.

6. Hospitals must complete the implementation of provisions of clause 4 Article 105 and Article 106 of this Decree before January 01, 2026.

7. The phrase "trang thiết bị y tế" is replaced with the phrase “thiết bị y tế” (there is no change in their meaning) in legislative documents promulgated before January 01, 2024.

8. Heading of Chapter IV of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is changed as follows:

“Chapter IV. CLINICAL TRIALS FOR MEDICAL DEVICES”.

9. Article 12 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 12. Clinical trial phases for medical devices

1. A clinical trial for medical devices other than in vitro diagnostic (IVD) medical devices has the following phases:

a) Phase 1: preliminary study on the safety of medical device for patients and its usability for medical practitioners and healthcare workers.

b) Phase 2: confirmatory study to ascertain and establish evidence for the safety and efficacy of medical device;

c) Phase 3: post-market study which is conducted after the medical device has been placed on market to collect additional evidences on the safety and efficacy of the medical device when used at the request of competent authorities.

2. A clinical trial for IVD medical devices has the following phases:

a) Phase 1: evaluation of clinical performance of the IVD medical device;

b) Phase 2: post-market study which is conducted after the IVD medical device has been placed on market to collect additional evidences on the safety and efficacy of the IVD medical device when used at the request of a competent authority.”.

10. Article 13 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 13. Exemption from clinical trials or some clinical trial phases before applying for marketing authorization for medical devices

1. The following medical devices will be exempt from clinical trials:

a) Class-A or Class-B medical devices;

b) Class-C or Class-D medical devices for which marketing authorization has been granted by the Ministry of Health of Vietnam or competent authorities of foreign countries.

2. Class-C or Class-D medical devices which are domestically manufactured and are not IVD medical devices will be exempt from the clinical trial Phase 1 if the following requirements are met:

a) The medical device has been manufactured employing a transferred technology which has been used in the manufacturing of a medical device granted marketing authorization by a competent authority, unless such marketing authorization has been revoked;

b) The subject medical device has the same indications for use as the one which has been granted marketing authorization by a competent authority as prescribed in point a of this clause.

3. The exemption from clinical trials or one or some clinical trial phases granted to medical devices used to serve urgent needs for national defense and security, epidemic prevention and control or disaster recovery shall be subject to the Ministry of Health of Vietnam’s decision.”.

11. Article 14 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 14. Requirements for medical devices undergoing clinical trial

1. All legal and technical requirements set out in documentation requirements for marketing authorization for a medical device are met.

2. The investigational medical device must be labeled as “for clinical trial only - not for any other purposes”. The labeling of the investigational medical device shall comply with regulations of law on labeling of goods.”.

12. Article 15 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 15. Eligibility requirements for institutions conducting medical device clinical trials

1. It must meet good clinical practices (GCP) for medical devices in accordance with regulations of the Minister of Health of Vietnam.

2. It is capable of performing scientific research function and has its scope of operation conformable with the medical device subject to the clinical trial.

3. It must be a juridical person whose organizational structure, personnel and finance are independent from the organization or individual whose medical device is subject to the clinical trial.”.

13. Article 16 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 16. Clinical trial dossier for medical devices

1. A clinical trial dossier for medical device includes: an application for approval of clinical trial, application for approval of changes in clinical trial, and application for approval of clinical trial results. Components of each application will comply with the provisions of Article 17 of this Decree.

2. Documentation requirements:

a) Documents included in the clinical trial dossier for a medical device must be made in Vietnamese. Documents in a language other than Vietnamese must be accompanied by their certified Vietnamese translations.

b) Documents issued by foreign regulatory authorities must bear consular legalization made in accordance with regulations of law on consular legalization, unless such consular legalization procedures are exempted in accordance with regulations of law.”.

14. Article 17 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 17. Components of a clinical trial dossier for medical device

1. An application for approval of clinical trial includes:

a) An application form made by the organization or individual whose medical device is subject to the clinical trial.

b) An application form made by the institution in charge of the clinical trial.

c) A competent authority’s written request in respect of the medical device which must undergo the clinical trial phase 3 or the IVD medical device which must undergo the clinical trial phase 2.

d) Documents on the medical device subject to the clinical trial, including:

- Description of the product (general information about the medical device subject to the clinical trial, including: name, characteristics, uses, indications, contraindications, technical specifications and other relevant information);

- Documents on preclinical study on the investigational medical device, including: study report on the safety and efficacy of the medical device, recommendations for use and storage of the medical device, and study reports on the stability and analytical performance (of IVD medical device) which have been appraised and certified to be satisfactory by the Expert Council of the institution conducting the clinical trial or the institution conducting preclinical study vested with certification task by the Ministry of Health of Vietnam;

- Documents on the clinical trial phases before the requested phase.

dd) Legal documents, including:

- Information on the owner and manufacturer of the medical device, manufacturing process;

- Technical file of the medical device;

- Technical standards applicable to the medical device as announced by its owner;

- Assessment report certifying that the medical device is conformable with technical standards provided by a qualified conformity assessment body as prescribed by law or quality assessment certificate issued by a competent authority of Vietnam;

- The approved user manual, if the medical device undergoes the clinical trial phase 3;

- Certificates of consent given by institutions participating in the trial;

- The clinical trial agreement signed by and between the authority, organization or individual whose medical device is subject to the clinical trial and the institution conducting the clinical trial; the research support agreement signed by and between the organization or individual whose medical device is subject to the clinical trial and the sponsor (if any).

e) Scientific documents, including:

- Description of the medical device clinical trial;

- Case Report Form (CRF);

- Informed consent forms given by the clinical trial participants.

g) Administrative documents:

- Academic resume and copy of certificate of completion of a training course in GCP, issued by the Ministry of Health of Vietnam or a qualified GCP training institution, of the principal investigator;

- A record of scientific and ethical assessment prepared by the internal Research Ethics Committee;

- Label of the investigational medical device as prescribed in clause 2 Article 14 of this Decree and its user manual.

2. An application for approval of changes in clinical trial includes:

a) For changes in administrative documents or contact information of the institution conducting the clinical trial: this institution shall take charge of reporting such changes to the Ministry of Health of Vietnam for information consolidation.

b) For replacement of the principal investigator or the institution conducting the clinical trial, the application shall include:

- An application form for approval of changes in clinical trial;

- Documents proving corresponding changes.

c) For changes other than those specified in points a and b of this Clause, the application shall include: 

- An application form for approval of changes in clinical trial;

- Updated versions of the corresponding documents specified in clause 1 of this Article, as changed.

3. An application for approval of clinical trial results includes:

a) An application form for approval of clinical trial results;

b) The copy of the approved clinical study protocol;

c) A copy of the decision to approve the clinical trial;

d) The record of appraisal of clinical trial results made by the internal Research Ethics Committee;

dd) Report on clinical trial results.”.

15. Article 18 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 18. Procedures for approving clinical trial

1. The clinical institution shall send an application for approval of clinical trial directly, online or by post to the Ministry of Health of Vietnam.

2. The Ministry of Health of Vietnam shall check the validity of the application within 05 working days from its receipt. If the application is valid, within 02 working days, the Ministry of Health of Vietnam shall transfer the application to the National Research Ethics Committee for appraisal and ethical considerations. If the application is invalid, within 02 working days, a written notice providing specific instructions for application modification shall be given to the applicant.

The clinical institution shall complete the application within 60 days from the receipt of the notice. After this period, procedures for approving clinical trial must be restarted.

3. The National Research Ethics Committee shall conduct review and ethical consideration of the trial on a periodical basis of every month.

4. Within 05 working days from the receipt of the certificate of approval of clinical trial given by the National Research Ethics Committee and the accompanied application, the Ministry of Health of Vietnam shall issue a decision to approve clinical trial.”.

16. Article 19 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 19. Procedures for approving changes in clinical trial

1. The clinical institution shall send an application for approval of changes in clinical trial directly, online or by post to the Ministry of Health of Vietnam.

2. The Ministry of Health of Vietnam shall check the validity of the application within 05 working days from its receipt. If the application is invalid, within 02 working days, the Ministry of Health of Vietnam shall give a written notice providing specific instructions for modification until the application is considered valid.

The clinical institution shall complete the application within 60 days from the receipt of the notice. After this period, procedures for approving changes in clinical trial must be restarted.

3. For changes specified in point b clause 2 Article 17 of this Decree: within 07 working days from the receipt of adequate and valid application, the Ministry of Health of Vietnam shall issue a decision to approve changes in clinical trial.

4. For changes specified in point c clause 2 Article 17 of this Decree:

a) If the application is valid, within 02 working days, the Ministry of Health of Vietnam shall transfer it to the National Research Ethics Committee for review;

b) The National Research Ethics Committee shall conduct review and ethical consideration of the trial on a periodical basis of every month;

c) Within 05 working days from the receipt of the certificate of approval of changes in clinical trial given by the National Research Ethics Committee and the accompanied application, the Ministry of Health of Vietnam shall issue a decision to approve changes in clinical trial.”.

17. Article 20 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 20. Procedures for approving clinical trial results

1. The clinical institution shall send an application for approval of clinical trial results, which must be made in Vietnamese, directly, online or by post to the Ministry of Health of Vietnam.

2. The Ministry of Health of Vietnam shall check the validity of the application within 05 working days from its receipt. If the application is valid, within 02 working days, the Ministry of Health of Vietnam shall transfer it to the National Research Ethics Committee for review. If the application is invalid, within 02 working days, the Ministry of Health of Vietnam shall give a written notice providing specific instructions for modification to the clinical institution.

The clinical institution shall complete the application within 60 days from the receipt of the notice. After this period, procedures for approving clinical trial results must be restarted.

3. The National Research Ethics Committee shall conduct review and ethical consideration of the trial on a periodical basis of every month.

4. Within 05 working days from the receipt of the certificate of approval of clinical trial results given by the National Research Ethics Committee and the accompanied application, the Ministry of Health of Vietnam shall issue a decision to approve clinical trial results.”.

18. Forms of documents and reports used in clinical trials for medical devices:

a) The application form for approval of clinical trial made by an organization or individual whose medical device is subject to the clinical trial included in the application for approval of clinical trial as prescribed in clause 14 of this Article shall be made using Form 10 in Appendix VI enclosed herewith;

b) The application form for approval of clinical trial made by a clinical institution included in the application for approval of clinical trial as prescribed in clause 14 of this Article shall be made using Form 11 in Appendix VI enclosed herewith;

c) Description of the clinical trial protocol included in the application for approval of clinical trial as prescribed in clause 14 of this Article shall be made using Form 12 in Appendix VI enclosed herewith;

d) The application form for approval of changes in clinical trial included in the application for approval of changes in clinical trial as prescribed in clause 14 of this Article shall be made using Form 13 in Appendix VI enclosed herewith;

dd) The application form for approval of clinical trial results included in the application for approval of clinical trial results as prescribed in clause 14 of this Article shall be made using Form 14 in Appendix VI enclosed herewith;

e) The report on clinical trial results included in the application for approval of clinical trial results as prescribed in clause 14 of this Article shall be made using Form 15 in Appendix VI enclosed herewith.

19. Article 30 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

a) Point h is added following point g clause 1 Article 30 as follows:

“h) Certificate of results of clinical trial for medical device issued by a competent authority, if the medical device is subject to a clinical trial as prescribed in clause 2 Article 94 of the Law on Medical Examination and Treatment.”.

b) Point c clause 2 Article 30 is amended as follows:

“c) The documents specified in Points b, c, d, dd, e and h clause 1 of this Article.”.

c) Point h is added following point g clause 4 Article 30 as follows:

“h) Certificate of results of clinical trial for medical device issued by a competent authority, if the medical device is subject to a clinical trial as prescribed by law.”.

d) Point e is added following point dd clause 5 Article 30 as follows:

“e) Certificate of results of clinical trial for medical device issued by a competent authority, if the medical device is subject to a clinical trial as prescribed in clause 2 Article 94 of the Law on Medical Examination and Treatment.”.

20. Provisions of clause 5 Article 105 of this Decree and clause 19 of this Article shall apply from January 01, 2026.

21. Article 32a is added to the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices as follows:

“Article 32a. Priority in processing applications for marketing authorization for medical devices

1. Processing of applications for marketing authorization for medical devices shall be prioritized in the following cases:

a) Domestically manufactured medical devices;

b) Imported medical devices for which applications for import license have been submitted to the Ministry of Health of Vietnam before January 01, 2022 but not yet been processed, and for which applications for marketing authorization have also been submitted;

c) Chemicals and preparations which are only used for decontamination of medical devices;

d) Medical devices which are employed for performing new techniques or methods in medical examination and treatment under official approvals given by the Ministry of Health of Vietnam but for which marketing authorization numbers have not yet been granted in Vietnam;

dd) Medical devices for which there is no change in information on type and HS code on the unexpired import license or decision to grant marketing authorization number or marketing authorization but which is subject to one of the following cases:

- There are changes in the importer or the applicant for marketing authorization;

- The name of the manufacturer is changed but its address;

- The name of the medical device’s owner is changed but its address;

e) A medical device for which there is no information on its type on the unexpired import license or decision to grant marketing authorization number or marketing authorization but information on product code on the same document is changed due to terminated manufacturing of products of the previous code;

g) The Ministry of Health of Vietnam has given a document rejecting, or requesting modification of, the submitted application for marketing authorization due to validity of one of the following documents: letter of authorization of the marketing authorization holder, certificate of conformity with ISO 13485 quality standards, or marketing authorization for the medical device;

h) The Ministry of Health of Vietnam has given a document rejecting, or requesting modification of, the submitted application for marketing authorization due to the name of the medical device.

2. Procedures for priority processing of an application for marketing authorization:

a) The applicant shall submit the following documents to the Ministry of Health of Vietnam:

- An application form for priority processing of the application which must indicate adequate information on the code of the submitted application for marketing authorization on the website of the Ministry of Health of Vietnam;

- Corresponding support documents for the cases specified in clause 1 of this Article;

b) The Ministry of Health of Vietnam shall consider permitting the priority processing of application for marketing authorization for medical device within 10 working days from its receipt of the application form for priority processing and accompanied documents. If an application is refused, a written response indicating reasons for such refusal shall be provided.

3. Applications for license to import medical devices prescribed in point b clause 1 of this Article for which marketing authorization has been issued shall not be rejected.".

22. The Government’s Decree No. 102/2011/ND-CP dated November 14, 2011 on liability insurance in healthcare sector shall cease to have effect from the effective date of this Decree.

23. Authorities issuing practicing licenses and operating licenses shall:

a) establish secretarial boards in charge of appraising applications for issuance, re-issuance and modification of practicing licenses falling within their jurisdiction;

b) establish counseling boards to provide advice in case of disputes that arise during the issuance, re-issuance, modification or renewal of practicing licenses falling within their jurisdiction;

c) establish appraisal teams to serve the issuance, re-issuance, modification or renewal of operating licenses falling within their jurisdiction.

Article 148. Responsibility for implementation

Ministers, heads of ministerial agencies, heads of Governmental agencies, Chairpersons of Provincial People’s Committees and relevant authorities, organizations and individuals are responsible for the implementation of this Decree.