How a metalworking company can enter medical device parts machining: common parts and materials, market trends, major makers, the PMD Act, ISO 13485 and the hurdles

Market trends: bigger, but the growth went to imports

According to MHLW's Statistics of Production by Pharmaceutical Industry, medical devices in 2024 (Reiwa 6) recorded domestic production of ¥2.6642 trillion, imports of ¥3.4542 trillion, exports of ¥1.1445 trillion and domestic shipments of ¥4.7083 trillion for the year^[1]. The domestic market (production minus exports plus imports) was about ¥4.9738 trillion, roughly 80% larger than the approx. ¥2.7479 trillion of 2015 (a rough guide only, since the survey method changed along the way)^[4].

However, most of the growth went to imports. Domestic production was flat at ¥2.4–2.7 trillion from 2019 to 2024, while imports rose from ¥2.6 trillion to ¥3.5 trillion^[1]. An MHLW survey report also classes Japan, along with the US and France, as a net importer, while China and Germany are net exporters^[7].

Notes on reading the figures① The survey method changed in 2019, and production came out 28% higher than the year before, so figures cannot be compared directly with 2018 and earlier^[1]. ② “Imports” in the statistics are the value of imported products when shipped in Japan, which differs from the import value in trade statistics^[1]. ③ The 2024 figures were revised in 2026 and differ from the initial release (imports ¥3.6056 trillion, domestic shipments ¥4.7195 trillion)^[1][2].

Which fields rely on imports

For metalworking companies, the category that stands out most is this one: Orthopedic products (artificial joints, bone fixation devices, etc.). In 2024, domestic production was ¥135.4 billion against imports of ¥523.7 billion, the largest of all import categories. The US supplied ¥246.7 billion, nearly half, followed by Switzerland at ¥51.6 billion, Ireland ¥47.9 billion, China ¥32.7 billion and Germany ¥27.9 billion. Orthopedic instruments, such as tools for cutting bone in surgery, also show production of ¥26.9 billion against imports of ¥83.1 billion^[1]. For hip prosthesis parts, one device maker has also stated that about 80% of the ceramic femoral heads used in Japan come from overseas^[8].

By contrast, endoscopes are a field where Japan is strong: of ¥265.0 billion produced, ¥259.3 billion is exported^[1]. There are 1,725 companies making medical devices in Japan; 86% of them produce less than ¥100 million a month, yet together they account for only about 8% of total production^[1]. Large makers carry most of the production, with many small producers and parts suppliers spread out beneath them. By prefecture, production value ranks Tochigi, Shizuoka, Ibaraki, Fukushima, Saitama, Aichi, Chiba in that order^[3], a useful guide when deciding which regions to target for sales.

The world medical device market was about $517 billion in 2023, with Japan ranked fourth after the US, Germany and China (about a 5% share). Growth of around 6% a year is expected (private research firm data cited in an MHLW document)^[7].

Major medical device makers

Below are the major device makers you might sell parts to, with sales for their latest fiscal year. Some figures are company-wide and some cover only the medical segment, so check the “Scope” column. We also list products that contain many machined metal parts.

Fiscal years and accounting standards differ by company, so these figures are not suited to ranking. Most large overseas makers have a Japanese subsidiary and import the products they sell in Japan. The big orthopedic makers (J&J, Stryker, Zimmer Biomet) are centered in the US, which matches the fact that nearly half of Japan's orthopedic product imports come from the US^[1]. For artificial joints there are also domestic makers, such as a Kyocera group company and Nakashima Healthforce (formerly Nakashima Medical)^[8][90].

Which metal parts are common

Nearly 80% of implantable medical devices are made of metal, and for orthopedic implants the figure is about 95%. Stents and guidewires are metal too, because they need both the elasticity to bend smoothly along blood vessels and the strength to keep a vessel propped open^[30].

Where lathe and machining center shops can best put their skills to use is in screws and rods for bone fixation and the spine, machining and finishing of artificial joints, surgical instruments, and precision parts for endoscopes and robots. Stents and guidewires belong to the specialist world of wire drawing and laser processing, so they are a stretch for machining shops.

Materials and standards

Standard titles checked on the JSA, ISO and ASTM pages^{[39][40][41][42][43][44][45][38]}. Drawings often specify materials by ASTM number, so also see the ASTM quick reference and Materials database (Ti-6Al-4V, 17-4PH, etc.).

Large parts: CT, MRI and other imaging systems

In contrast to the small parts that go inside the body, imaging systems are built around rotating assemblies about 1 m across and magnet vessels weighing several tons. Looking at medical devices made in Japan in 2024 by generic name, whole-body X-ray CT systems ranked first at ¥88.1 billion. Superconducting whole-body MR systems (MRI) came to ¥31.4 billion. The category that includes CT, “medical X-ray equipment,” exported ¥126.7 billion of its ¥226.0 billion production (the US being the top destination) against imports of ¥80.4 billion: a field where Japan is on the making-and-selling side^[1]. On the user side, too, Japan has 184 CT, MRI and PET units per million people, far above the OECD average of 51^[91].

CT and MRI systems are controlled medical devices (Class II) and also “specified maintenance-controlled medical devices,” which require specialist management for installation and maintenance^[92][93]. Even so, as with other medical devices, a company that makes parts to drawing and delivers them does not need a PMD Act license (see the section on the law). Since most are structural parts that never touch the body, what matters is less cleanliness than dimensions, runout, balance, welding and non-magnetic properties.

Makers producing imaging systems in Japan

Among overseas players, Siemens Healthineers' Imaging segment had €13.182 billion (FY ended Sep 2025)^[104], and Philips' Diagnosis & Treatment €8.531 billion (2025)^[107]. Siemens' Japanese subsidiary handles import sales, repair and maintenance, and does not manufacture in Japan^[103]. GE HealthCare lists Siemens Healthineers, Philips, United Imaging (China), Mindray (China) and Canon as its main global competitors^[106].

CT: a rotating assembly about 1 m across

MRI: multi-ton magnets and "non-magnetic" parts

Parts near an MRI must be "non-magnetic"Annealed SUS304 is not attracted to a magnet, but cold working turns it into martensite and makes it magnetic. SUS316L transforms less readily, but heavy working still gives it weak magnetism^[138]. In measurements by ORIST (Osaka Research Institute of Industrial Science and Technology), the relative permeability of SUS304 was 1.024 on the flat part of a sheet, 1.051 at a bend, 1.225 at the thread of a bolt and 1.624 at its head^[139]. Bending, heading and heavy cutting bring out magnetism, so if the drawing specifies permeability, add a step to measure with a low-permeability meter after machining. In MRI rooms, there have been accidents in which oxygen cylinders or IV stands brought in were pulled into the magnet^[140].

Where to pitch large parts

• Canon: Its "Procurement Information" page has a form for supplier proposals and the steps to start doing business^[108].
• Shimadzu: Its procurement policy and contact (Procurement Department) are public, and quality control and CSR are checked before business starts^[109].
• Fujifilm: The group's procurement policy is public^[110].
• GE HealthCare Japan: Publishes supplier requirements and information on its supplier portal^[111].
• Regional contacts: Tochigi Prefecture is recruiting members for an industry promotion council that covers medical and welfare equipment, and companies planning to enter can join^[112]. Chiba Prefecture's "Chiba Medical Network" supports matching with device makers and medical sites^[113].
• Supplying component makers: Japanese bearing makers also mass-supply CT bearings in Japan and abroad (2008 announcement)^[119], and there are overseas specialists in bearings, slip rings and X-ray tubes^{[120][122][123]}. Instead of going to equipment makers directly, you can also take on housings and structural parts for these component makers.

Who large equipment parts suitCompanies that already have large lathes, vertical lathes, horizontal boring mills, 5-axis gantry machines, large-part welding and annealing, and CMMs, and have made large parts for semiconductor equipment or machine tools. Rather than in the world of cleaning and sterilization that implants live in, you can compete on records of dimensions, runout, balance, welding and non-magnetism. Of the medical rules, advance notice of changes and traceability (section on the law) are required here just the same.

The machining: difficult-to-cut materials and “after cutting”

What changes on the shop floor is "after cutting"Even if the dimensions are right, a part left with burrs, cutting oil or iron particles is a reject in medical work. For products that go through a step to remove machining oils and the like, the MAH has to document its cleanliness and contamination-control requirements (QMS Ordinance, Art. 41)^[61]. Expect your cutting oil brand, washer settings, deburring method and marking method to become conditions of the deal itself. For cutting conditions, see the cutting conditions calculator; for tool wear, the tool life article.

The law: does a parts maker need a license?

In the medical device world, licensing is split between the marketing authorization holder (MAH) licence, held by whoever is responsible for placing devices on the market (Type 1–3 licences depending on the risk of the devices), and manufacturer registration for each site where devices are made^[58]. Manufacturer registration is required for sites that carry out design, main assembly and other main manufacturing steps, sterilization, or storage of finished products in Japan (for general medical devices, the three other than design)^[59].

However, being outside the law is not the same as having nothing required of you. MAHs are subject to the QMS Ordinance (aligned with ISO 13485:2016 by a 2021 revision; the inspection standard since March 26, 2024)^[62], and through their purchasing controls, requirements reach parts companies^[61].

• Selected, and watched continuously (Art. 37): You are evaluated on your ability to supply, track record, impact on quality and the risk of the intended use; your performance is monitored and you are re-evaluated^[61].
• Orders come with process, equipment and personnel requirements (Art. 38): Purchasing information covers not just specifications but requirements for in-plant procedures, processes and equipment, operator qualification and the quality system. In addition, agreeing in writing that "changes affecting conformity will be notified in advance" is mandatory^[61].
• Receiving inspection and on-site audits (Art. 39): The scope of verification depends on risk, and you may be subject to witnessed inspections or audits^[61].
• Traceability (Arts. 48 and 49): Traceability down to components, and for implantable devices, records down to the components and work-environment conditions that affect quality^[61]. You need material mill certificates and lot records.
• Validation for processes that can't be checked afterward (Art. 45): For processes such as cleaning, passivation and welding, whose results can't be verified afterward, the process itself is validated, with procedures covering equipment, operators, acceptance criteria and approval of process changes^[61]. In the industry, installation, operational and performance qualification of equipment are called IQ, OQ and PQ.

Product liability and contracts

A government survey also lists as an issue cases where component makers refuse or hesitate to supply for medical devices, fearing they will be held liable for medical accidents^[68]. The Product Liability Act provides a component-manufacturer defence: if a defect arose solely from following the finished-product maker's design instructions and you were not negligent, you are not liable (Art. 4(2); the parts company bears the burden of proof)^[67]. A METI pamphlet says there were 4 product liability lawsuits involving medical devices in Japan from 2012 to 2021, and in none was a component supplier found liable^[65].

ISO 13485: do you need it, and when to get it

ISO 13485 (JIS Q 13485:2018 in Japan) is a quality management standard that adds medical-device-specific requirements to ISO 9001^[69]. The biggest difference from ISO 9001 is that "regulatory compliance comes first", and it adds risk management throughout product realization, contamination control, validation, traceability and more^[70].

• Not mandatory for parts companies: The standard's introduction says suppliers providing components and the like "can choose it voluntarily, or may be required to by contract"^[69]. With it, some customers may waive their second-party audit^[70].
• Time and order: According to certification bodies, it takes roughly 1–1.5 years from starting to registration, and you need a shipping record for the products in scope. More parts and materials makers are getting certified^[71]. So rather than "certify first, then sell", it is realistic to get certified in parallel with your first customer.
• Cost: Audit fees are quoted individually based on headcount and number of sites; there is no published guideline^[71]. Get quotes from several certification bodies.
• Revision: ISO 13485:2016 was "confirmed" without revision, and one certification body says the current edition will stay until 2030^[72].

Rules overseasThe US FDA's quality rule was revised to incorporate ISO 13485 by reference (QMSR) and took effect on February 2, 2026^[73]. This rule does not apply to manufacturers of components or parts of finished devices, but the same thinking reaches them through manufacturers' purchasing controls^[74]. The EU MDR also requires manufacturers' quality systems to include the selection and control of suppliers and subcontractors, and notified bodies can make unannounced audits at supplier sites if needed^[75]. If you work with overseas manufacturers, you may face audits in English.

Entry routes and where to get support

• Trade shows: Closest to pitching parts machining is the Medical Device Development Expo (MEDIX) (Tokyo, June 16–18, 2027; Osaka, October 6–8, 2027)^[78]. Medtec Japan 2027 runs April 21–23, 2027, at Tokyo Big Sight^[77]. Medical Japan focuses mainly on hospitals and nursing care^[79].
• Medical Device Development Support Network (MEDIC): An AMED program with the University of Tokyo Hospital as secretariat; it offers consultation on development and commercialization^[80]. The Guidebook on Supplying Materials and Components is also posted there^[64].
• AMED's Medical-Engineering Collaboration Global Expansion Program: Subsidies for development with medical institutions and MAHs (two-thirds subsidy rate, up to 70 million yen a year for non-clinical work). Applications for FY2026 closed in February^[81].
• PMDA's RS General Consultation: Free, about 20 minutes per session. Questions about business licences themselves go to the prefecture's pharmaceutical affairs division^[82].
• Regional contacts: Tokyo Medical-Engineering Collaboration HUB Organization^[83], the Osaka Chamber of Commerce and Industry's Next-Generation Medical System Industrialization Forum (matching meetings and sales pitch sessions)^[84], Fukushima Medical Device Development Support Center^[85], Shizuoka Prefecture's Pharma Valley Center^[86] , among others.

Companies that have entered

Order of steps to entry (guideline)

1. Choose your target field: Equipment parts, surgical instruments and implants have very different requirements. Start close to your strengths (difficult-to-cut materials, micro parts, long parts, mirror finishes). A survey by the Kinki Bureau of Economy, Trade and Industry lists these as keys to success: personal connections, taking an objective view of demand for the end product, choosing jobs where spec changes are kept in check and that can be made steadily for a long time, and using outside expertise where you are weak^[76].
2. Add the systems: Build lot traceability, change control, procedures for cleaning, burrs and foreign matter, and contract templates (approved specification, change notification) on top of ISO 9001.
3. Prototypes and audits: Undergo the manufacturer's factory audit and submit prototypes and inspection certificates. For cleaning and passivation, validation records are required too.
4. Production and ISO 13485: Once you have a shipping track record, go for certification^[71]. Certification also helps when selling to overseas manufacturers and contract manufacturers.

The real hurdles and how to deal with them

Compared with aerospace and defense

Titanium alloy machining and record keeping pay off in both aerospace and medical. In fact, some companies make titanium alloy implants and endoscope parts alongside parts for aircraft and semiconductor equipment^[89].

FAQ

Do I need a medical device manufacturer registration just to machine parts?

As a rule, no. The customer, who bears substantial responsibility for the quality of the product, registers. However, registration is required if you carry out the sterilization yourself for parts whose sterility must be assured, or if you take on the whole process as a contract manufacturer responsible for the product^[60]. If in doubt, check with your customer or the pharmaceutical affairs division of your prefectural government.

Can I do business without ISO 13485?

It is not a legal requirement; it depends on the customer^[69]. But certification requires a shipping track record^[71], so the realistic approach is to start your first business with ISO 9001 plus medical-oriented procedures (traceability, change control, cleaning) and pursue certification in parallel.

If there is an accident, can the parts maker be sued too?

If you made the part as instructed by the customer's design and were not negligent, you are not liable under the component-manufacturer defence (Art. 4(2)) of the Product Liability Act^[67]. This is also why you exchange approved specifications and keep inspection records^[64].

Which field is easiest to enter?

Parts for equipment that does not touch the body often have lighter requirements for cleanliness and the like than implants, so they suit building a track record (it depends on the part's role, so check with your customer). Surgical instruments and implants have heavier requirements, but for that reason there are fewer domestic makers; orthopaedic product imports in particular are about 4 times domestic production^[1].

Where can I buy material?

Drawings specify material by standards such as ISO 5832 or ASTM F136, so buy material that comes with a mill certificate to that standard from distributors approved by the customer. It may also be customer-supplied, so check before quoting.

Hole and fit data: Fits and Tolerances, and dimensional change from surface treatment: How to tell black oxide from plating, and how dimensions change; rising tool prices: Tungsten Price Surge and Carbide Tools.