Offers applicant initial feedback on their situationTakes place 7-10 days following consultation requestFree of charge
2nd Consultation:Provides assistance with application without prior review of application documents (i.e. new vs. partial change application)Cost: about 36,000 yen (about $350 USD)
3rd Consultation:MHLW gives recommendation on expectations for regulatory processRecommendation provides insight into what the MHLW is likely to do, but is non-binding Cost: about 1,700,000 yen (about $16,000 USD)
There are new consultations types that the PMDA is currently proposing.
Healthcare SystemIncreased spending on healthcare, but over 80% of population is without health insurance.50% of people who should seek medical care do not.47% of urban citizens and 31% of rural inhabitants self-medicate instead of going to hospitals.Changing epidemiological profile
Pricing Policy for Medical DevicesSome medical device products can be reimbursed or co-paid by National Essential Medical Insurance and prices are controlled by the government.National Development and Reform Commission (NDRC) issues price caps.NDRC has issued various price caps, such as only allowing the price of disposable medical devices increasing 40% or less from manufacturer to patient.NDRC also plans to strengthen price monitoring and lower sales margins for medical devices sold to hospitals.
Increased SupervisionSFDA has increased its QA and GMP enforcement with recent bribery scandal of former SFDA head.Increased unannounced GMP inspections, establishment of SFDA’s regional branch responsibilities in terms of daily administration and supervision of medical device manufacturers.Increased inspection to ensure proper labeling and translation of key documents in Chinese.
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Medical Device MarketLocal non-multinational medical manufacturers are small, low tech, generally low cost, and medium quality: some are FDA/CE approved.
There are about 120 significant local medical companies, of which 25 are large companies.Products include syringes, needles, urine bags, gloves, oxygen supply tubing, condoms, stents.
Multinational medical companies also manufacture/import into India.
These include: Bausch & Lomb, Baxter, Boston Scientific, J&J, Becton Dickinson, Siemens, Philips, GE Medical Systems, Zeiss, B. Braun, Terumo.
Healthcare SystemPublic sector share is 70% and private sector is 30% of healthcare delivery.Healthcare delivery market has recently grown at 13% per year and is expected to grow at 15% per year over the next 5 years.Growth will be in both public and private sectors, though higher in the private sector.As of now only 25% of population has access to allopathic healthcare, as other systems of medicine also used.
Definition of DeviceThere is NO specific definition for a “device”in the Drug & Cosmetics Act (DCA).DCA defines a “drug” as including any medicine or substance which is used for treatment, prevention, mitigation, diagnosis of disease or condition, and any devices notified as drugs by the Government.
Product RegistrationCertain devices specified for regulation include disposable hypodermic syringes, tubal rings, perfusion sets, IVD kits for HIV/HCV, surgical dressings etc.After March 2006, new devices were added including cardiac stents, drug eluting stents, catheters, heart valves, orthopedic implants, etc.Device registration uses drug forms and laws as templates.
Insurance & ReimbursementThere is no single national health insurance system.What exists is a number of schemes of free/ concessional treatments and insurance, mainly for hospitalization.There is no system of pre-approval of drugs or devices for treatment / reimbursement.
Proposed Structure for Device RegulationCreate a Central Drug Authority of India “CDAI” (like the USFDA) headed by the Drug Controller General of India (DCGI), in place of the Central Drugs Standard Control Organization (CDSCO)All manufacturing and import licensing with CDAI, State FDAswill inspect factories and grant wholesale/ retail licenses.Define Medical Devices and nutraceuticals specifically under the DCA and provide rules and guidelines for their regulation.CDAI has been approved by the Cabinet but legislation still pending.
KoreaKorea Food and Drug Administration (KFDA), main regulatory body under Ministry of Health and Welfare.Devices MUST be approved in countries of manufacture before product registration in Korea can start.Medical Device Act enacted in 2003, full enforcement planned by May 2007 To sell devices in Korea, you need to have a product license, Korean Good Manufacturing Practice certification and a Device Business License (Class II and III; Class I just needs a notification to government).
SingaporeCurrently, voluntary registration for medical devices.Main regulatory body is Health Sciences Authority (HSA). New Health Products Bill presented in January 2007.
Regulate manufacture, import, supply, presentation and advertisement of medical products
Hong KongVoluntary registration under Medical Device Administrative Control System (MDACS).Medical Device Control Office (MDCO) is main regulatory body. Conformity Assessment Framework official for medical devices November 2006.
MalaysiaOnly radiation-emitting devices such as x-ray equipment have specific requirements for import and registration now.Only recently began regulations on medical devices with introduction of Voluntary Registration of Medical Devices Establishments (MeDVER) in 2006.
ConclusionNext few years important as more nations create regulatory authorities to oversee industry.With ever-changing regulations, medical device companies and manufacturers will need to keep abreast of this evolving regulatory climate.In each market, have a well thought-out strategy.
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