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In short
On 8 November 2021, the Authorities issued Decree No. 98/2021/ND-CP on administration of medical gadgets (“Decree 98“). Decree 98 took impact from 1 January 2022 and changed Decree No. 36/2016/ND-CP, Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP.
- Decree 98 units out new rules on the registration numbers of medical gadgets and a brand new fast-track approval course of for the registration of Class C and D medical gadgets.
- Decree 98 units out new rules on import licenses, product classification, value administration measures, commercial, medical trials, and post-market administration.
1. Product registration/notification
Underneath Decree 98, Class A and B medical gadgets are topic to product notification with the native Division of Well being. In the meantime, Class C and D medical gadgets are topic to product registration with the Ministry of Well being.
The registration numbers of Class A, B, C and D medical gadgets will stay legitimate indefinitely.
Nevertheless, the validity of registration numbers in emergency instances involving epidemic prevention and management and pure catastrophe restoration shall be topic to the Minister of Well being’s choice, relying on every particular case.
The Frequent Submission File Template (CSDT) utility might be obligatory from 1 January 2022.
Quick-track approval for Class C and D registrations
Within the following instances, product registrations are eligible for fast-track approval:
a. Medical gadgets which have been issued a Certificates of Free Sale (CFS) or Market Authorization (MA) by any of the next authorities:
- Meals and Drug Administration (FDA) – USA
- Therapeutic Items Administration (TGA) – Australia
- Well being Canada, Ministry of Well being, Labor and Welfare (MHLW) or Prescription drugs and Medical Gadgets Company (PMDA) – Japan
- EU member international locations, the UK and Switzerland
- Nationwide Medical Merchandise Administration (NMPA) – China, Ministry of Meals & Drug Security (MFDS) – Korea
- Different organizations that grant market authorization acknowledged by Vietnam
b. Medical gadgets which have been issued import license or registration numbers or CFS below business type in Vietnam
2. Import license
The import license solely applies to merchandise with no registration quantity, reminiscent of these used for scientific analysis, testing, inspection, experiments, medical trials, high quality analysis, coaching, donation, reward, show, exhibition, product introduction, and many others.
3. Product classification
Not like the earlier rules, Decree 98 permits the applicant to categorise merchandise by itself. This can assist simplify the classification course of and save value for the applicant.
4. Worth administration
Decree 98 units out new rules on value administration measures for medical gadgets in an effort to deal with shortcomings and inadequacies within the earlier value administration system, as follows:
- Declare the costs of medical gadgets earlier than circulation in Vietnam and replace costs on the Ministry of Well being portal.
- Listing the wholesale and retail costs of medical gadgets in Vietnamese dong on the place of transaction or the place of sale of medical gadgets of the institution buying and selling medical gadgets; publicly announce such costs on the board, on paper or in different varieties.
- Publicize the successful bids for medical gadgets of public medical services.
- Not purchase or promote medical gadgets with no declared value and never purchase or promote larger than the value declared on the web site of the Ministry of Well being on the time of buy and sale.
Earlier than 1 April 2022, the holders of registration numbers or of import licenses issued earlier than 1 January 2022 should declare the costs of medical gadgets as prescribed by this Decree.
5. Info and commercial
Registration quantity holders and buying and selling institutions are liable for publishing danger ranges and different info associated to using medical gadgets.
Previous to releasing commercials, the registration quantity holder or its delegate is liable for publishing on the portal of the Ministry of Well being the promoting content material and type.
The requirement to publish promoting content material for medical gadgets will take impact from 1 July 2022.
6. Medical trials
Decree 98 units out the rules on medical examine phases for medical gadgets, necessities for medical gadgets present process medical examine, necessities for organizations conducting medical examine on medical gadgets, medical examine dossiers, procedures for approval of medical examine on medical gadgets, procedures for approval of adjustments to medical examine on medical gadgets, procedures for approval of medical examine outcomes for medical gadgets, obligations of organizations or people whose medical gadgets are present process medical examine, and the obligations of medical examine establishments.
7. Submit-market administration
Decree 98 requires the registration quantity holder to prepare and handle the tracing of the origin of medical gadgets positioned in the marketplace and totally retain the related paperwork to help the administration of medical gadgets.
Decree 98 additionally units out rules on: (i) dealing with of medical gadgets that pose a severe risk to public well being or could result in customers’ demise; (ii) actions to be taken in case of an opposed occasion (AE) that has brought on hurt to the well being of customers; (iii) dealing with, restore and recall of faulty medical gadgets; and (iv) dealing with of medical gadgets in case the product proprietor or registration quantity holder not engages in manufacturing, goes bankrupt or is dissolved.
The total Vietnamese textual content of the Decree might be discovered right here.
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