FDA's device registration and listing files, exported 2026-09-07, carry 4,704 FDA-registered device manufacturing establishments in China. Of those, 151 establishments list at least one product code that FDA flags as an implant, 3.2%. The United States count under the same filter is 6,502 FDA-registered manufacturing establishments, of which 1,215 list an implant-flagged code, 18.7%.
That difference is the working gap between a country's device manufacturing base and its implant bench, and it is the figure a sourcing or supply-chain director at an implant OEM needs when a corporate China-plus-one directive arrives. The strategy lead at a US or European implant contract manufacturer, pricing against Asian competition, needs the same figure from the other side of the quote.
What changes for both is where the shortlist comes from. For implants sold into the US market, Vietnam, Malaysia and Thailand hold 32 FDA-registered implant-listing manufacturing establishments between them, while Mexico and Costa Rica hold 73 and Ireland holds 43. A plant that is not registered with FDA and listing an implant code is a supplier-qualification and registration project. Registration is an annual fee and a form, and a listing rides on the OEM's own premarket submission, so the administrative part is small; a plant that has been through neither still carries a schedule before it carries parts.
Sourcing staff who have bought orthopaedic implants for a decade know the clusters and do not need a federal file to tell them where bone screws are made. These counts quantify a familiar direction and put a figure on places where the direction is normally asserted without one.
The bench by country
The same activity filter across the whole file returns 19,937 FDA-registered manufacturing establishments, including a single row that carries no country code, and 101 countries when the file's distinct non-null country codes are counted. The twelve countries below are the ones a shortlist reaches for. In each case the first figure is FDA-registered manufacturing establishments, the second is those with at least one implant-flagged listing, and the third is the share.
- The United States holds 6,502 FDA-registered manufacturing establishments and 1,215 implant-listing ones, 18.7%.
- China holds 4,704 FDA-registered manufacturing establishments and 151 implant-listing ones, 3.2%.
- Germany holds 956 FDA-registered manufacturing establishments and 170 implant-listing ones, 17.8%.
- South Korea holds 830 FDA-registered manufacturing establishments and 105 implant-listing ones, 12.7%.
- France holds 375 FDA-registered manufacturing establishments and 97 implant-listing ones, 25.9%.
- Mexico holds 310 FDA-registered manufacturing establishments and 48 implant-listing ones, 15.5%.
- Vietnam holds 265 FDA-registered manufacturing establishments and 9 implant-listing ones, 3.4%.
- Switzerland holds 249 FDA-registered manufacturing establishments and 77 implant-listing ones, 30.9%.
- Malaysia holds 222 FDA-registered manufacturing establishments and 15 implant-listing ones, 6.8%.
- Thailand holds 151 FDA-registered manufacturing establishments and 8 implant-listing ones, 5.3%.
- Ireland holds 123 FDA-registered manufacturing establishments and 43 implant-listing ones, 35%.
- Costa Rica holds 64 FDA-registered manufacturing establishments and 25 implant-listing ones, 39.1%.
Thailand's total of 151 FDA-registered manufacturing establishments happens to be the same figure as China's implant-listing count of 151 establishments. They are counts of different things and the coincidence is worth flagging before either lands in a slide.
What FDA's implant flag counts
The flag follows the regulatory definition of a device intended to stay in the body for thirty days or more. Implant-flagged product codes therefore include sutures, surgical mesh, staples and clips alongside joints, plates and spinal hardware, which lifts every country's count above what a sourcing team would call an implant plant.
Narrowing it changes the size of the bench and leaves the ordering alone. Dropping implant-flagged codes whose device name matches suture, mesh, staple, clip, dressing, marker, stent or drain leaves 104 FDA-registered manufacturing establishments in China and 1,070 in the United States, with the country ordering unchanged.
Part of the Chinese share is what the bench lists at all. In China, 55.7% of FDA-registered manufacturing establishments list only 510(k)-exempt product codes, against 33.6% in the United States. Restrict both countries to establishments holding at least one listing in a code that is not 510(k)-exempt and the implant share is 7.2% in China and 27.9% in the United States.
What the Chinese implant bench makes
Of China's 151 implant-listing FDA-registered manufacturing establishments, bone fixation screws (product code HWC) are listed by 28, bone fixation plates (HRS) by 20, knee prostheses (JWH) by 19, intramedullary rods (HSB) and nail, blade and plate fixation appliances (KTT) by 16 each, and dental implant abutments (NHA), pedicle screw systems (NKB) and hemostatic gastrointestinal clips (PKL) by 15 each.
The US bench leads with the same orthopaedic family at a different scale: 263 FDA-registered manufacturing establishments list HWC, 225 list HRS, 209 list MAX and 200 list NKB.
FDA's medical specialty field gives one more cut of the same registry. In China, 53 implant-listing establishments list a code in the Orthopedic specialty, against 593 in the United States.
Southeast Asia and the nearshore bench
The destinations that come up on a China-plus-one brief do not read alike. Vietnam's 265 FDA-registered manufacturing establishments include nine that list an implant-flagged code, 3.4%, and one of those nine lists a code in FDA's Orthopedic specialty; the nine are suture makers, dental laboratories and captive Japanese plants. Thailand's 151 FDA-registered manufacturing establishments include eight establishments that list an implant-flagged code, 5.3%, one of which lists an Orthopedic-specialty code. Malaysia's 222 FDA-registered manufacturing establishments include 15 establishments that list an implant-flagged code, 6.8%, and nine of those 15 establishments list a code in FDA's Orthopedic specialty, the largest of the three counts.
The nearshore and European benches are on a different scale relative to their size. Mexico holds 48 implant-listing establishments of 310, 15.5%; Costa Rica 25 of 64, 39.1%; Ireland 43 of 123, 35%. Mexico and Costa Rica together hold 73 implant-listing FDA-registered manufacturing establishments.
Ownership sits behind those numbers. In Mexico, 35 of the 48 implant-listing establishments have an owner-operator number that also appears on a US-registered establishment; in Costa Rica 21 of 25, in Ireland 25 of 43, and in China 15 of 151. In China, 96 implant-listing establishments declare the contract-manufacturer activity, against 647 in the United States. Behind China's 151 implant-listing establishments are 146 owner-operators, against 953 owner-operators behind the 1,215 in the United States, so the Chinese bench is close to one plant per owner.
Inside the US figures, 45 FDA-registered manufacturing establishments are in Puerto Rico, 23 of which list an implant-flagged code. Any comparison that treats the US count as mainland-only is already off by that much.
Two grains, two answers
At establishment grain, one row counted is one registration number. At listing grain, one row is a registration number paired with a product code, which measures catalogue breadth rather than plant count. In classified product codes held by FDA-registered manufacturing establishments, implant-flagged listings are 9,574 of 61,529 in the United States (15.6%), 703 of 33,964 in China (2.1%), 974 of 13,869 in Germany (7%), 648 of 2,220 in Switzerland (29.2%), 396 of 1,307 in Ireland (30.3%), 216 of 5,077 in Mexico (4.3%) and 324 of 3,253 in South Korea (10%).
The two grains disagree in two countries. Mexico reads 15.5% at establishment grain and 4.3% at listing grain, because its plants list broad non-implant catalogues. Malaysia reads 6.8% at establishment grain and 19.6% at listing grain, on 308 implant listings. For a shortlist of plants, establishment grain is the figure to use.
What has already been published
FDA publishes the inputs and displays no country-level implant share of its own. The agency's Establishment Registration & Device Listing search exposes the country and product-code fields, and Registration and Listing (openFDA) serves the same data in bulk, so any reader can rebuild these counts and a competitor can rebuild them quickly. GAO-08-780T, Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments is the nearest official use of registered foreign establishment counts, framed as inspection coverage by device class rather than implant composition. Trade coverage such as Costa Rica Emerges as Medtech Nearshoring Hub (MD+DI) asserts the nearshore implant cluster qualitatively and supplies no establishment-level shares.
Consultancy posts that chart FDA-registered manufacturer counts by country were not checked for this piece, and if one of them has already published implant density by country, these counts confirm rather than add.
How the numbers were counted
The establishment file, export 2026-09-07, supplies the denominators. One row counted is one registration number. The filter keeps establishments whose establishment_types field contains 'Manufacture Medical Device' or 'Manufacture Medical Device for Another Party (Contract Manufacturer)'. Country is the establishment's iso_country_code, and the US figures include Puerto Rico, identified by state_code PR. The period is the snapshot as at that export, 2026-09-07.
The establishment listing file, export 2026-09-07, supplies the product codes each registration holds. One row is a registration number paired with a product code. Listings in product codes that have no row in the classification file are excluded from the listing-grain counts.
The product code file, export 2026-09-07, supplies implant_flag, submission_type_id and medical_specialty_description. An establishment counts as implant-listing when at least one of its listings falls in a product code with implant_flag 'Y'. 510(k)-exempt means submission_type_id 4. The narrower implant definition drops implant-flagged codes whose device_name matches suture, mesh, staple, clip, dressing, marker, stent or drain. The owner-operator counts are distinct owner_operator_number values across a country's implant-listing manufacturing establishments, and the US-site proxy marks an establishment whose owner_operator_number appears on any US-registered establishment.
What these files cannot say
The registered bench is the US-market bench. China has a large orthopaedic implant industry serving its domestic market and Europe that never registers with FDA, so 151 FDA-registered implant-listing establishments is a floor on Chinese capability. What would settle capability is a source outside this corpus, such as NMPA registrations or EU MDR certificates counted by country, and neither is in these files.
Registration and listing are administrative facts. The obstacle in front of a sourcing team is supplier qualification: audits, process validation, material traceability, capability studies. None of that is in the registry, and no figure here should be read as evidence that a listed plant can build a part to an OEM's drawing.
Listing an implant code does not make an establishment available to buy from. Captive plants owned by large implant OEMs sit inside every country's count, and intra-group plants declare the contract-manufacturer activity when they make for a sister entity, so the 96 establishments in China and 647 in the United States that carry that activity include capacity nobody outside the group can book. The owner-also-holds-a-US-site proxy mixes captive plants with the offshore sites of US-headquartered contract manufacturers, which are genuine suppliers. Only reading the owner names separates them, so no count of available suppliers appears here.
Contract sterilizers and packagers register as manufacturers and list the implant codes they handle, which puts service sites inside the implant-listing counts. Across these twelve countries the effect is too small to move a share, though a ranking of establishments by portfolio size would be distorted by it.
The Orthopedic specialty counts understate spine. Several spinal implant codes carry an Unknown specialty in the classification file, so the orthopaedic subsets for China, the United States, Vietnam, Malaysia and Thailand are conservative.
The files are a snapshot as exported on 2026-09-07 and carry no record of what any country's bench held earlier, so nothing above is a trend.
