Border[HEALTH EQUIPMENT, IN VITRO DIAGNOSTIC HEALTH EQUIPMENT, AND PKRT]

Distribution License for Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Products

Izin Edar Alat Kesehatan, Alat Kesehatan Diagnostik In Vitro, dan PKRT

Regulation Details

Legal Basis: Peraturan Menteri Kesehatan Nomor 60 Tahun 2017 jo Kepmenkes Nomor HK.01.07/MENKES/234/2018
Issuing Authority: Ministry of Environment (KLHK)
Effective From: March 31, 2022
Affected HS Codes: 130 products

What This Means

This regulation requires importers to obtain a Distribution License for Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Products before clearing goods through Indonesian customs.

As a border regulation, the permit must be obtained before the goods arrive at the Indonesian port. Without this document, customs will not release the shipment.

An Importer of Record (IOR) with the proper licenses can handle this requirement on your behalf.

Affected HS Codes

39232119Articles for the conveyance or packing of goods, of plastics; stoppers, lids, caps and other closures, of plastics; Sacks and bags (including cones); Of polymers of ethylene; Aseptic bags reinforced with aluminium foil (other than retort pouches), other 39232990Articles for the conveyance or packing of goods, of plastics; stoppers, lids, caps and other closures, of plastics; Sacks and bags (including cones); Of other plastics, other 39232910Articles for the conveyance or packing of goods, of plastics; stoppers, lids, caps and other closures, of plastics — Aseptic bags whether or not reinforced with aluminium foil (other than retort pouches), of a width of 315 mm or more and of a length of 410 mm or more, incorporating a sealed gland 39233090Articles for the conveyance or packing of goods, of plastics; stoppers, lids, caps and other closures, of plastics; Carboys, bottles, flasks and similar articles, other 39232111Articles for the conveyance or packing of goods, of plastics; stoppers, lids, caps and other closures, of plastics — Of a width of 315 mm or more and of a length of 410 mm or more, incorporating a sealed gland 39232191Articles for the conveyance or packing of goods, of plastics; stoppers, lids, caps and other closures, of plastics — Aseptic bags not reinforced with aluminium foil (other than retort pouches), of a width of 315 mm or more and of a length of 410 mm or more, incorporating a sealed gland 39232199Articles for the conveyance or packing of goods, of plastics; stoppers, lids, caps and other closures, of plastics; Sacks and bags (including cones); Of polymers of ethylene, other 39249030Tableware, kitchenware, other household articles and hygienic or toilet articles, of plastics — Supplementary feeding system for babies 30049010Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale — Transdermal therapeutic system patches for the treatment of cancer or heart diseases 30049030Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale — Antiseptics 30061010Pharmaceutical goods specified in Note 4 to this Chapter — Sterile absorbable surgical or dental yarn; sterile surgical or dental adhesion barriers, whether or not absorbable 30063030Pharmaceutical goods specified in Note 4 to this Chapter — Other microbial diagnostic reagents 30059020Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes — Gauze 30061090Pharmaceutical goods specified in Note 4 to this Chapter; Sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical or dental yarns) and sterile tissue adhesives for surgical wound closure; sterile laminaria and sterile laminaria tents; sterile absorbable surgical or dental haemostatics; sterile surgical or dental adhesion barriers, whether or not absorbable, other 30064010Pharmaceutical goods specified in Note 4 to this Chapter — Dental cements and other dental fillings 30065000Pharmaceutical goods specified in Note 4 to this Chapter — First-aid boxes and kits 30064020Pharmaceutical goods specified in Note 4 to this Chapter — Bone reconstruction cements 30069100Pharmaceutical goods specified in Note 4 to this Chapter — Appliances identifiable for ostomy use 30069290Pharmaceutical goods specified in Note 4 to this Chapter; Waste pharmaceuticals, other 33079050Pre-shave, shaving or after-shave preparations, personal deodorants, bath preparations, depilatories and other perfumery, cosmetic or toilet preparations, not elsewhere specified or included; prepared room deodorisers, whether or not perfumed or having disinfectant properties — Contact lens or artificial eye solutions 34013000Soap; organic surface-active products and preparations for use as soap, in the form of bars, cakes, moulded pieces or shapes, whether or not containing soap; organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap; paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent — Organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap 34070020Modelling pastes, including those put up for children's amusement; preparations known as �dental wax� or as �dental impression compounds�, put up in sets, in packings for retail sale or in plates, horseshoe shapes, sticks or similar forms; other preparations for use in dentistry, with a basis of plaster (of calcined gypsum or calcium sulphate) — Preparations known as "dental wax" or "dental impression compounds", put up in sets, in packings for retail sale or in plates, horseshoe shapes, sticks or similar forms 34070030Modelling pastes, including those put up for children's amusement; preparations known as �dental wax� or as �dental impression compounds�, put up in sets, in packings for retail sale or in plates, horseshoe shapes, sticks or similar forms; other preparations for use in dentistry, with a basis of plaster (of calcined gypsum or calcium sulphate) — Other preparations for use in dentistry, with a basis of plaster (of calcined gypsum or calcium sulphate)35069110Prepared glues and other prepared adhesives, not elsewhere specified or included; products suitable for use as glues or adhesives, put up for retail sale as glues or adhesives, not exceeding a net weight of 1 kg — Optically clear free-film adhesives and optically clear curable liquid adhesives of a kind used solely or principally for the manufacture of flat panel displays or touch-sensitive screen panels 35061000Prepared glues and other prepared adhesives, not elsewhere specified or included; products suitable for use as glues or adhesives, put up for retail sale as glues or adhesives, not exceeding a net weight of 1 kg — Products suitable for use as glues or adhesives, put up for retail sale as glues or adhesives, not exceeding a net weight of 1 kg

Need help with this regulation?

Kickrate handles all permit applications as your Importer of Record.

Get a Quote