Jordan Medical Device Legal Framework: Three-Tier Chain of Laws and Directives

1. Key takeaways

The legal structure of Jordanian medical device regulation is a three-tier chain: the institutional law (Law No. 41, 2008) answers “who regulates”, the Drugs and Pharmacies Law (Law No. 12, 2013) answers “on what authority”, and the subordinate importation directives, circulation criteria and registration guidelines answer “how it is regulated”.

GRZAN stresses a point that is easy to miss: although Law No. 12 is named “Drugs and Pharmacies”, it functions as the general law for health product regulation in Jordan, and the competence to regulate medical devices is derived from it. The inspections, penalties and circulation controls a company encounters in Jordan often carry their legal consequences under this general law rather than under the instruments specifically named after devices.

The third conclusion is that Jordan does not have a stand-alone “medical device law”. Device regulation is dispersed across an enabling provision in the higher-tier law plus a set of subordinate specialised documents. This means regulatory research must cover the circular layer: anyone who reads only the statute layer will miss the rules with the greatest executive force.

• Three tiers: an institutional law, a general health product law, and a body of subordinate directives, criteria and guidelines.
• Law No. 12 of 2013, though named for drugs and pharmacies, is the umbrella basis for device regulation.
• No single device statute exists; the operative rules are spread across directives, criteria, guidelines and circulars.
• Circular-level research is mandatory, because the most immediately enforceable rules live there.

Read as a whole, the three tiers operate as one system rather than as separate references. A question about whether a product may be imported is answered by a directive, but the enforceability of that directive rests on the umbrella law, and the body that applies all of them exists only because the institutional law created it. Companies that map their obligations tier by tier, starting from the institutional law and descending to the circulars, obtain a complete and stable picture of Jordanian compliance; companies that start from a single document tend to misjudge both scope and sequence.

2. Legal basis

The six laws below together constitute the statutory framework within which JFDA operates, as listed by the Jordanian General Budget Department in its official chapter statement on JFDA.

Provision numbers are subject to the Arabic original texts of the Jordanian Official Gazette.

3. Expert insights

Insight 1: the umbrella law defines the radius of JFDA’s supervision. Law No. 41 grants JFDA control over food, drugs and related substances, and devices are brought within the scope of “related substances”. A practical consequence follows: JFDA’s enforcement instruments against devices — spot checks, detention, recalls and penalties — share their origin with those used for drugs, and their force exceeds what is seen in some markets where devices have their own dedicated statute.

Insight 2: Law No. 33 of 2017 is the real lever at the circulation stage. The 2017 Law on Regulating and Inspecting Economic Activities provides the procedural basis for JFDA’s on-site inspections, sampling and penalties at circulation premises. In handling Jordan market surveillance matters, GRZAN finds that the legal basis for JFDA inspection actions against clinics, beauty establishments and points of sale mostly comes from this law rather than from the device-specific directives. Companies should therefore brief their distributors on this law as thoroughly as on the device directives, because the inspection script that field officers follow is written there.

Insight 3: cross-application of laws creates combined risk. Devices containing animal-derived ingredients may touch TSE/BSE requirements; devices containing medicinal substances must submit composition, indications, contraindications and stability data as drug-device combination products; devices containing narcotic or psychotropic substances fall under Law No. 23 of 2016. A market access assessment must therefore search both the device line and the drug line at the same time.

4. Practical recommendations

• Build a five-tier regulatory register covering law, directive, criterion, guideline and circular. Jordanian compliance evidence is not contained in one document, and missing any tier leads to misjudgement.
• Run an ingredient review early for products with special ingredients. Animal-derived, drug-derived and narcotic/psychotropic ingredients each carry separate documentary requirements in Jordan, and the issuing cycles are long.
• Put circulation-stage compliance into the agreements. The inspection cooperation duties of the AR and distributors at circulation premises should be expressly stipulated in the distributor agreement, so that responsibility does not hang unresolved when an inspection occurs.
• Keep translation-ready copies of the umbrella law and the key subordinate documents, so that a regulatory query can be answered with the precise instrument within one working day.

5. Verification checklist

• □ Check whether the current list of laws in JFDA’s statutory framework has added or repealed any law
• □ Confirm whether the product constitutes a drug-device combination that triggers drug-line requirements
• □ Confirm whether the product contains animal-derived ingredients and needs TSE/BSE certificates
• □ Confirm whether the product contains narcotic or psychotropic substances governed by Law No. 23 of 2016
• □ Search current JFDA circulars for any dedicated provisions on the intended product category
• □ Re-verify the cited provision numbers against the Arabic original texts of the Official Gazette

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Jordanian market. Our team manages Jordan Food and Drug Administration (JFDA) registrations, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com