Decree 103/2016/ND-CP was issued by the government on July 1, 2016, replacing Decree 92/2010/ND-CP, amending and supplementing certain points regarding the assurance of biosafety in laboratories. Notable points include the following:
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Regulations in Article 2 Decree 103/2016/ND-CP, the business establishments providing pathogenic microorganism testing services must meet the condition of being legally established under the law, and must have standardized laboratories. Additionally, establishments involved in medical examinations and treatments must comply with the legal provisions on medical examinations and treatments.
Additional Conditions for Bio-safety Testing Facilities:
Regarding the conditions of Level IV bio-safety testing facilities, Decree 103 also stipulates certain supplementary contents in Decree 92/2010/ND-CP concerning the conditions for four levels (I, II, III, IV) in Articles 5, 6, 7, and 8. For Level I testing facilities, Decree 103 no longer requires a minimum area of 12m² (excluding the area for administrative work related to testing); it adds requirements about the floor, walls, and testing surface being smooth, waterproof, heat and corrosion-resistant, and easy to clean and sanitize; adequate electrical grounding and backup power supply; and sufficient lighting for testing purposes. Similarly, the requirements for the remaining facility levels are also supplemented. Therefore, facilities not meeting the required conditions must make the necessary adjustments within the validity period of the Bio-safety Certificate to avoid penalties during inspections by competent authorities.
Regarding human resources for Level I bio-safety facilities, Decree 103 specifically requires that the testing facility must have at least two testing staff, with staff directly performing the tests needing appropriate diplomas or certificates. The Decree also requires each facility to have regulations on testing practices, including rules for entering and exiting testing areas, reporting policies, guidelines for using equipment related to testing activities, health, and medical monitoring; procedures for decontaminating and handling waste and maintaining appropriate testing procedures and record-keeping.
New Issuance, Reissuance, and Revocation of Bio-Safety Certificates under New Procedures:
The content in Article 10 of Decree 103, states that Level III and IV bio-safety facilities remain under the management of the Minister of Health (except those under the management of the Ministry of Defense). For Level I and II bio-safety facilities, the Directors of the Department of Health will no longer follow the old procedures for appraisal, new issuance, reissuance, and revocation. Instead, the new Decree assigns the facilities to self-declare compliance with Level I and II bio-safety standards. Based on this declaration, the Department of Health will post the list of testing facilities meeting Level I and II bio-safety standards on its electronic information portal.
It can be seen that the new procedure for Level I and II bio-safety facilities will streamline time-consuming procedures and reduce travel costs for appraisal staff. This can expedite the establishment of testing facilities that meet the regulatory conditions, addressing the medical needs of remote and difficult areas where often only Level I and II bio-safety testing service establishments can be sufficiently established.
