Commercialisation of healthcare in South Korea: overview

A Q&A guide to the commercialisation of healthcare in South Korea.

This Q&A provides an overview of the regulatory framework for the commercialisation of medical products in South Korea. It covers the key requirements for manufacturing, advertising and selling drugs, medical devices, biological products and natural health products.

To compare answers across multiple jurisdictions, visit the commercialisation of healthcare Country Q&A tool.

This Q&A is part of the Commercialisation of Healthcare Global Guide. For a full list of jurisdictional Q&As visit www.practicallaw.com/healthcare-guide.

Contents

Regulatory overview

1. What is the regulatory framework for medical products?

Legislation

The Pharmaceutical Affairs Law (PAL) and subordinate regulations govern most aspects of the commercialisation of pharmaceuticals, biological products and quasi-pharmaceuticals. Medical and assistive devices are regulated by the Medical Devices Law (MDL), although certain assistive devices designated by the Ministry of Health and Welfare (MOHW) (for example, prosthetic hands, foot orthoses and orthopaedic footwear) are regulated under the Disabled Persons Welfare Act (DPWA) and related rules and regulations.

Many pharmaceuticals, biological products and medical devices are reimbursed through a public health insurance system, and matters relating to pricing and reimbursement are governed by the National Health Insurance Act.

Nutritional supplements can be regulated as one of the following:

  • Food, under the Food Sanitation Act (FSA).

  • Health functional food, under the Health Functional Food Act (HFFA).

  • Drugs, under the PAL.

In addition, general anti-trust and fair trade statutes apply to the marketing and advertising of medical products including the:

  • Monopoly Regulation and Fair Trade Law (FTL).

  • Act on Fair Labelling and Advertising (AFLA).

Regulatory authorities

The two principal regulators in charge of medical products are the:

  • MOHW.

  • Ministry of Food and Drug Safety (MFDS).

For more information on the MFDS, MOHW and other relevant regulatory authorities, see box: The regulatory authorities.

Private parties

Generally, private parties (including product manufacturers and importers, industry associations, NGOs and so on) play a limited role in regulatory approval of medical products. Where applicable, the manufacturers and importers prepare and submit the dossier for product approval to the authority and participate indirectly in policy formation by submitting comments during the notice-and-comment period.

In the case of pharmaceuticals, biological products and medical devices, after market approval is obtained, the approval holder applies to the relevant authorities to set the reimbursement price. Private health insurers provide coverage for certain payments that are not reimbursed by the national health insurance, such as the patient co-paid amount of reimbursed treatments.

 
2. What types of medical products are regulated?

The following medical products are regulated in South Korea:

  • Pharmaceuticals.

  • Quasi-pharmaceuticals (that is, a category of product including deodorants and toothpaste).

  • Herbal medicines.

  • Traditional medicines (that is, Korean folk remedies).

  • Biological products.

  • Medical devices.

  • Health functional foods (see Question 19).

Under the Pharmaceutical Affairs Law (PAL), a drug is defined as:

  • A product other than a quasi-drug which is listed in the Korean Pharmacopoeia.

  • A product that is used for the purposes of diagnosis, medical care, alleviation, treatment or prevention of disease in human beings or animals, excluding appliances, machinery and equipment.

  • A product other than an appliance, machinery or equipment that is used for the purpose of exerting pharmacological effects on the structure or functions of human beings or animals.

Under the Medical Devices Law (MDL), a medical device is defined as an instrument, machine, device, material or any other similar product used to diagnose, cure, alleviate, correct or prevent a disease, injury or impairment. The definition of medical device generally encompasses assistive devices. Most medical devices and assistive devices are regulated under the MDL and subordinate rules and regulations. Certain assistive devices designated by the Ministry of Health and Welfare (MOHW), such as prostheses and orthoses (for example, prosthetic hands, foot orthoses and orthopaedic footwear), are regulated by the Disabled Persons Welfare Act (DPWA) and related rules and regulations.

 

Drugs

3. What are the general requirements for a drug to be manufactured, advertised and sold?

Manufacturing

Generally, a company seeking to manufacture a drug in South Korea for sale must both:

  • Be duly licensed/authorised.

  • Obtain product registration (also referred to as marketing approval) from the Ministry of Food and Drug Safety (MFDS) for the manufacturing of each drug.

The product registration of patented drugs must follow the new drug application (NDA) procedure. The NDA dossier consists of:

  • Data regarding the drug's safety and efficacy (including stability, toxicity, pharmacological action and clinical data).

  • The standards and testing methods used for the drug.

  • Good manufacturing practice (GMP) evaluation data.

  • A drug master file (DMF), which is a GMP evaluation for the drug's active pharmaceutical ingredient.

The clinical data package to be submitted as part of the NDA dossier is developed through consultation with the MFDS, which has substantial discretion over materials that must be included. A recurring issue is whether a bridging study (that is, a testing of the drug on the Korean population to determine any impact that ethnic differences may have on its safety and efficacy) should be included in the clinical data package. Pre-NDA meetings with MFDS personnel are available to give applicants a sense of what will be required in the application package and to expedite the application process. The processing periods for GMP and DMF evaluations are 90 and 120 business days, respectively. It is possible to facilitate the process by commencing DMF approval early, before initiation of the NDA procedure.

Applicants seeking marketing approval of generic drugs for the South Korean market can follow the abbreviated new drug application (ANDA) procedure. The basic ANDA dossier comprises:

  • Safety and efficacy data.

  • The standards and testing methods used for the drug.

  • GMP evaluation data.

  • DMF.

However, the standards and testing methods review need not be submitted if the drug is one that is listed in the Korean Pharmacopeia or other pharmacopeia recognised by the MFDS, such as those of the US, EU, UK, Germany, France and Japan. In addition, registration of a generic drug under the ANDA procedure does not require the submission of clinical trial data, provided that there is sufficient data showing that the drug in question is therapeutically interchangeable with the reference drug. Therapeutic interchangeability can be demonstrated by submitting bioequivalence data, comparative dissolution test data or physical chemistry equivalence data, depending on the nature of the drug. As with the NDA process, the processing periods for GMP and DMF evaluations are 90 and 120 business days, respectively.

Under the GMP certification system, which has been in effect since 2014, the GMP evaluation is waived for a product if the product's manufacturer already underwent GMP evaluation for another product with the same dosage form in the previous three years. This applies to both generic and patented drugs.

Finally, an expedited form of review called reporting procedure is available for:

  • Drugs listed in the Korean Pharmacopeia or other pharmacopeia recognised by the MFDS.

  • Drugs that are identical to an already registered drug, excluding the generic of a new drug or biological product.

  • Drugs that are otherwise deemed acceptable for reporting by the MFDS.

However, in practice, the review of applications under the reporting procedure typically lasts almost as long as for drugs subject to approval, as a GMP evaluation (with the usual review period of 90 business days) is usually required, whether by statute or at the discretion of the MFDS.

Advertising

As a general rule, advertisements that use false, misleading or exaggerated expressions regarding a product's effect or efficacy are prohibited. Direct-to-consumer advertising for ethical drugs is banned. Advertising requirements are discussed in further detail in Question 8.

Sale

To sell drugs in South Korea, companies other than manufacturers and importers must:

  • Obtain a pharmaceutical wholesaler licence.

  • Comply with good supply practice (GSP) requirements.

 
4. Are there different requirements for patented and generic drugs?

Patented drugs are subject to the new drug application (NDA) process while generic drugs are subject to the abbreviated new drug application (ANDA) procedure (see Question 3).

Until recently, the Korean regulatory authorities issued market approval for generics even where the original drug was still protected by a patent. However, as a result of the Korea–US Free Trade Agreement, patent holders are entitled to a certain period of protection for patents listed in the Green List (which is similar to the US Food and Drug Administration's Orange Book). Once a patent is placed on the Green List, the patent holder will be given notice of any application for market approval concerning a generic drug. The patent holder can then petition the government to prohibit the marketing of the generic drug, provided that certain requirements are met (such as having filed a patent litigation regarding the generic). In such a case, a generic drug can be subject to a sales ban of up to nine months.

 
5. What authority is responsible for regulating the manufacture, advertising and sale of drugs?

The Ministry of Food and Drug Safety (MFDS) regulates the manufacture, importation and advertising of drugs, while the Ministry of Health and Welfare (MOHW) is responsible for issues relating to the sale and distribution of drugs. The Korea Fair Trade Commission (KFTC) can also be involved in matters such as compliance with fair trade laws in the course of the sale and advertising of drugs.

For more information on the MFDS, MOHW and KFTC see box: The regulatory authorities.

 
6. Are there fewer or different requirements for drugs that have already been licensed/approved in another jurisdiction?

An applicant needs not submit toxicological and pharmacological data for drugs that are both:

  • Used in a country other than the country where the drug was developed.

  • Listed in the drug compendium of any one of eight listed nations (that is, the US, Japan, UK, Germany, Switzerland, Canada, Italy and France), provided that the compendium was published in the three years preceding the application.

 
7. Is it possible to sell drugs to or buy drugs from other jurisdictions?

As for drug manufacturers, importers of drugs must obtain a product registration for each drug (see Question 3, Manufacturing), and starting September 2015, will also be required to be licensed by the MFDS as pharmaceutical importers. Selling unregistered drugs obtained overseas is prohibited. In addition, South Korean residents are not permitted to buy drugs online from sellers operating abroad.

For pharmaceutical products manufactured in South Korea and sold in other jurisdictions, a pharmaceutical manufacturer licence and product registrations for the relevant products are required. The documentation submission requirements on safety, efficacy or quality may be relaxed or waived for a pharmaceutical product that is exclusively manufactured for export purposes. Good manufacturing practice (GMP) certification is required even for products that are manufactured for export purposes.

 
8. Is it permitted to advertise drugs to consumers? Are there restrictions on advertising?

Under the Pharmaceutical Affairs Law (PAL), only drugs for which market approval has been obtained can be advertised in South Korea. Advertising unapproved drugs can subject the advertising company to criminal and administrative sanctions. As a general rule, the mass advertising of drugs to consumers by means such as print, broadcast, television and internet is prohibited for ethical drugs other than certain vaccines. The indirect advertising of ethical drugs, which occurs when a company refers to diseases or disorders while displaying the company's name or corporate logo in such a way that consumers can identify the drug that is being alluded to, is also prohibited. However, direct-to-consumer advertisements of certain vaccines for infectious diseases designated by statute are permitted, as well as advertising in professional and academic media that is targeted at medical experts.

Over-the-counter (OTC) drugs can be advertised through media such as print, broadcast, television and internet, but the relevant advertisement must be reviewed and approved by the Korea Pharmaceutical Manufacturers Association (KPMA).

Companies cannot engage in the following when advertising pharmaceutical products (PAL):

  • False advertising or advertisements using superlatives regarding the relevant product's name, manufacturing process, efficacy or effect.

  • Advertisements that suggest that a healthcare professional (for example, a doctor, dentist, practitioner of oriental medicine or veterinarian) or other individual has endorsed the relevant product's efficacy or effect.

  • Advertisements that include suggestive articles, pictures, diagrams, designs and other visual depictions regarding the relevant pharmaceutical's efficacy or effect, or which use other suggestive methods.

  • Advertisements involving documents or designs suggesting abortion.

  • Advertisements regarding the name, manufacturing process, efficacy or effect of a product for which a manufacturing or import product registration has not been obtained from the health authorities.

Additional restrictions are set out in the Regulation on the Safety of Pharmaceuticals (issued under the PAL), including:

  • Prohibition on advertisements that denigrate other products (whether or not the claim made is true).

  • Examples of language and advertising methods that may be misleading or otherwise improper.

 

Medical devices

9. What are the general requirements for a medical device to be manufactured, advertised and sold?

Manufacturing

A medical device manufacturer must obtain:

  • A business licence.

  • A product registration for each product.

  • Good manufacturing practice (GMP) certification for each category of product that the company manufactures (there are 26 product categories).

Medical devices are classified into four classes, depending on the possible health risks posed by the devices:

  • Class I medical devices are subject to a reporting requirement only. This means that the medical device can be manufactured or imported after the device has been registered using the Ministry of Food and Drug Safety's (MFDS) online registration system. Information to be provided includes, among others, the product's name, specifications, intended use, operation methods, warnings and origin of manufacture.

  • Classes II to IV consist of medical devices that must be approved by the MFDS. Technical documentation is the most important part of the application for approval. Whether the product is equivalent to existing products is determined by an MFDS-approved third party institution that considers factors such as equivalence in the medical devices' intended use, principle of operation, material composition, performance, specifications and operation methods. If there is no equivalence, submission of a clinical data report is required. For new medical devices, new technologies, new intended uses for class II medical devices and all class III/IV medical devices, the MFDS requires submission of technical documentation including clinical trial data in order to conduct a review of the medical device's safety and efficacy. The technical documentation for certain class II medical devices designated by the MFDS is reviewed by an MFDS-authorised third party institution. All other technical documentation is reviewed directly by the MFDS.

Additionally, a company must obtain GMP certification from an MFDS-authorised evaluation body before submitting an application for product approval. The certification process includes an audit of the manufacturing site. Class II, III and IV medical devices are subject to this audit. A GMP certification is valid for three years, while business and product approvals are valid for an unlimited period of time provided that the product is not modified.

To be an official holder of a manufacture or import product registration, an entity must be located in South Korea. Therefore, a foreign entity must establish a branch or subsidiary in South Korea or designate a third party domestic entity to obtain the product registration.

Any person engaged in the business of manufacturing, modifying, repairing or attaching prostheses and/or orthoses must:

  • Notify the competent local government of the business's establishment within seven days of starting such business.

  • Employ at least one prosthesis/orthosis technician.

Other than the notification procedure, the Disabled Persons Welfare Act (DPWA) does not expressly require any separate registration or approval. However, the DPWA requires prostheses and orthoses to be manufactured or modified only in accordance with a doctor's prescription.

Advertising

As a general rule, mass advertisements are subject to pre-review by the Korea Medical Devices Industry Association (KMDIA). A seller need not obtain pre-review for advertisements produced by the manufacturer or importer if such manufacturer/importer already obtained the KMDIA's review for the advertisement. If the seller produces its own advertisement, such advertisement must be reviewed by the KMDIA.

Sale

Manufacturers can sell products they manufacture if they hold a valid manufacturer licence and the relevant product registrations, and have received GMP certification. Importers can import and sell products manufactured overseas once they have an importer licence, relevant product registrations, and a GMP certification is obtained for the overseas manufacturer.

Sellers other than manufacturers or importers must obtain a sales business licence from the relevant municipal authorities (that is, the si, gun or gu governments, to which this responsibility has been delegated by the MFDS).

 
10. What authority is responsible for regulating the manufacture, advertising and sale of medical devices?

The Ministry of Food and Drug Safety (MFDS) is responsible for regulating the manufacture, advertising and sale of medical devices. Certain matters, such as the review of advertisements, have been delegated to the Korea Medical Devices Industry Association (KMDIA). Prostheses and orthoses are regulated by the Ministry of Health and Welfare (MOHW).

For more information on the MFDS and MOHW see box: The regulatory authorities.

 
11. Are there fewer or different requirements for medical devices that have already been licensed/approved in another jurisdiction?

Licensing or approval of medical devices in other jurisdictions does not directly affect the product registration process in South Korea, but may have an indirect effect. In the case of medical devices, the Ministry of Food and Drug Safety (MFDS) allows certain materials (including test reports) that are required for product approval to be substituted with documents confirming that the material was submitted to and approved by the relevant foreign government, or an institution authorised by such government to provide approval.

 
12. Is it possible to sell devices to or buy devices from other jurisdictions?

To import and sell medical devices, companies must obtain an importer licence, product registration for the relevant products and GMP certification for the overseas sites where the imported products are to be manufactured. See also Question 9, Manufacturing.

Companies that manufacture devices to be sold in other jurisdictions must hold a manufacturer licence and the relevant product registrations. The submission requirements (for example, the technical documentation requirement) may be relaxed or waived for medical devices that are manufactured exclusively for export purposes. In addition, GMP certification is only required when the medical device is to be imported and sold in South Korea, not when the device is manufactured solely for exportation. However, a Korean manufacturer must satisfy itself of meeting all the relevant requirements applicable in the jurisdiction where it intends to sell the devices.

Selling/buying prostheses and orthoses to/from other jurisdictions will likely be permissible if the requirements outlined in Question 9 are satisfied.

 
13. Is it permitted to advertise medical devices to consumers? Are there restrictions on advertising?

Under Korean law, there are no specific restrictions on who can advertise medical devices, or to whom. However, those wishing to advertise through mass media such as daily newspapers, television or radio must obtain prior approval from the Korea Medical Devices Industry Association (KMDIA). Advertisements in certain professional media are exempt from this prior approval requirement.

The following is prohibited:

  • Advertisements that contain falsehoods or exaggerations regarding the name of a medical device, its manufacturing methods, performance, efficacy or effectiveness, or principles of operation.

  • Advertisements that are likely to mislead people into believing that doctors, dentists, traditional medicine specialists, veterinarians or other persons guarantee, recommend, certify, instruct use of or recognise the performance, efficacy or effectiveness of the medical device, or that such persons use such device.

  • Advertisements that use suggestive articles, photographs, drawings or other materials regarding the performance, efficacy or effectiveness of a medical device.

  • Advertisements that encourage abortion or make use of obscene text or images.

  • Advertisements that make use of the name, manufacturing methods, performance, efficacy or effectiveness of a medical device that has not been approved.

  • Advertisements in mass media such as daily newspapers, television or radio which have not been subject to prior review and approval, or advertisements whose contents differ from what has been approved.

  • Any other advertisements prohibited by the Ministry of Health and Welfare (MOHW).

The Disabled Persons Welfare Act (DPWA) and its subordinate rules and regulations do not specifically regulate the advertising of prostheses and orthoses. The relevant legislation that is more generally applicable is the Act on Fair Labelling and Advertising (AFLA). AFLA prohibits advertising and labelling that is false, exaggerated, deceptive, slanderous or makes use of unfair comparisons.

 

Biological products

14. What are the general requirements for a biological product to be manufactured, advertised and sold?

In South Korea, biological products are regulated as drugs under the Pharmaceutical Affairs Law (PAL).

Manufacturing

See Question 3, Manufacturing.

Advertising

See Question 3, Advertising.

Sale

See Question 3, Sale.

 
15. What authority is responsible for regulating the manufacture, advertising and sale of biological products?
 
16. Are there fewer or different requirements for biological products that have already been licensed/approved in another jurisdiction?
 
17. Is it possible to sell biological products to or buy biological devices from other jurisdictions?
 
18. Is it permitted to advertise biological products to consumers? Are there restrictions on advertising?

Certain vaccines against infectious diseases can be advertised to consumers. However, biological products other than vaccines can only be advertised in professional and academic media. See also Question 8.

 

Natural health products

19. Is there a category for natural health products (including, for example, traditional medicines, homeopathic medicines, supplements, vitamins and minerals)?

Many natural health products fall within the category of health functional foods. The Health Functional Food Act (HFFA) defines health functional foods as food products intended to "enhance and preserve human health with one or more functional ingredients".

The health functional food category was established in 2004 to account for food products that could not be categorised as either general food or drug, and are intended to aid the maintenance of human health. This new category was designed to encompass the growing number of food products that made claims to potentially improve health or body functions, and which fell somewhere between drugs and general foods, but were distinguishable from drugs.

Accordingly, while traditional medicine products that are intended to cure or treat a specific ailment or disease are not health functional foods, homeopathic products purporting to assist with a specific function, dietary supplements, vitamins, minerals and other similar products qualify as health functional foods.

Functional ingredients, which form the basis of the health functional food designation, are classified according to the health benefit claims that are associated with such ingredients. There are three categories of claims:

  • Claims regarding the physiological effects of the nutrients on the human body with respect to growth, development or other normal bodily functions.

  • Other functional claims regarding positive contributions to health which may be achieved through the improvement of bodily functions or the enhancement or preservation of health in the context of a person's daily diet.

  • Claims regarding reduction of disease risk which may be achieved in the context of a person's daily diet.

However, in practice, the most significant categories of functional ingredients are:

  • Ingredients listed in the Health Functional Food Code.

  • Ingredients that are not listed in the Code but are marketed following individual recognition by the Ministry of Food and Drug Safety (MFDS).

 
20. What are the general requirements for natural health products to be manufactured, advertised and sold?

The primary laws governing the general food and health functional food industries are the Food Sanitation Act (FSA) and Health Functional Food Act (HFFA), which establish the requirements for the importation, manufacture, distribution and sale of all food products. Depending on the categorisation of a natural health product as either a general food or a health functional food, separate requirements apply regarding classification, labelling, ingredients and business licence registration.

Health functional foods

Manufacturing. The HFFA requires manufacturers of health functional foods to:

  • Manufacture the relevant products at a facility that meets certain standards or requirements.

  • Obtain a manufacturer licence from the Ministry of Food and Drug Safety (MFDS).

  • Report to the MFDS before manufacturing particular Health Functional Foods.

Advertising. Any label or advertisement of health functional foods must be subject to pre-censorship review by the Korea Health Supplement Association (KHSA). However, such review is not required if the label or advertisement only reiterates the standards or functions of the relevant product as promulgated by the MFDS. All television broadcasts are usually also subject to censorship by the Korea Communications Standards Commission.

In addition, the HFFA prohibits labelling or advertising health functional foods in a way that may mislead consumers into believing that the product is a pharmaceutical product, or includes any unapproved functional claims on the product's label or advertising materials.

Sale. Under the HFFA, companies selling health functional foods (including importers) must have facilities that meet certain standards and report on their business to the relevant municipal authority.

General food

Manufacturing. Under the FSA, persons who intend to engage in the business of producing or processing food products must:

  • Have facilities that meet certain criteria prescribed by the MFDS.

  • Obtain a food manufacturer licence from the relevant municipal authority.

Manufacturers must be aware of and comply with the relevant laws and regulations. A key obligation is to make sure that products only contain ingredients and additives approved under the Food Code or the Food Additive Code. Food products containing non-approved ingredients and/or additives cannot be manufactured, imported or sold in South Korea. There is an exception for ingredients and additives that, although not included in the Food Code or Food Additive Code, are approved individually under an official ruling of the MFDS.

Advertising. Manufacturers and importers of food products must ensure that their product bears a Korean-language label listing all the required information (for example, product name, list of ingredients, nutritional facts, manufacturer/distributor information, expiration date, country of origin, and so on).

Sale. Manufacturers can sell food products based on their manufacturer licence without the need to obtain a separate sales licence. Importers and other sellers that are not the product's manufacturer must report their business to the relevant municipal authorities.

 
21. What authority is responsible for regulating the manufacture, advertising and sale of natural health products?

The manufacturing, advertising and sale of health functional foods are generally regulated by the Ministry of Food and Drug Safety (MFDS) (for certain matters, regulation is delegated to local governments by the MFDS).

Other authorities, such as the Korea Fair Trade Commission (KFTC) and the police/prosecutors, can become involved if a complaint or report is submitted to them. For example, a competitor may file a complaint with the KFTC for an advertisement that allegedly violates the Act on Fair Labelling and Advertising (AFLA).

For more information on the MFDS and KFTC, see box: The regulatory authorities.

 
22. Are there fewer or different requirements for natural health products that have already been licensed/approved in another jurisdiction?

Licences or approvals obtained in other jurisdictions do not formally reduce the requirements for the manufacture and sale of natural health products in South Korea. However, in certain cases, the fact that a product has been approved, sold and used successfully in other jurisdictions may be used to support the product's safety. For example, when applying to use individually approved health functional food ingredients (that is, ingredients that only companies that have been approved by the authorities under the Health Functional Food Act (HFFA) can handle), companies must submit information, if any, on whether and to what extent the ingredient is recognised and used in South Korea and abroad, as part of general information regarding the product. In other words, the fact that a product has been licensed or approved in other jurisdictions can be helpful in applying for manufacturing approval and sale in South Korea.

 
23. Is it possible to sell natural health products to or buy natural health products from other jurisdictions and/or electronically?

Generally, the parallel importation of products is permitted in South Korea, provided that the manufacture, advertising and sale of all health functional foods and other food products comply with the laws and regulations discussed in Questions 19 and 20.

Foods to be exported to other jurisdictions are treated as any other food, and there is no separate set of provisions applicable to such products.

 
24. Is it permitted to advertise natural health products to consumers? Are there restrictions on advertising?

The Health Functional Food Act (HFFA) requires pre-approval of all advertisements and labels of health functional foods. This pre-censorship review is conducted by the Korea Health Supplement Association (KHSA) under the authority of the Ministry of Food and Drug Safety (MFDS). The purpose of pre-approval is to prevent consumers from being misled about the relevant product. Therefore, the KHSA conducts its review to ensure that any label or advertisement does not:

  • Mislead consumers into believing that the relevant food is effective in preventing or treating a disease, or cause consumers to mistakenly think that the relevant food is a medicine.

  • Include names (including oriental medicine prescriptions) usually used for medicines only.

  • Contain slanderous labelling or advertising regarding other companies or their products.

For natural health products that are not categorised as health functional foods, the restrictions on advertising under the Food Sanitation Act (FSA) apply. Under the FSA, the same principles against false or exaggerated labels and/or advertising apply, as well as pre-censorship approval in accordance with the guidelines of the MFDS.

 

Reform

25. Are there any plans to reform the rules on the development, manufacture, advertising and sale of medical products?

The third edition of the IEC 60601-1 technical standards on device safety/effectiveness has been applied/is scheduled to apply to electronic medical devices from the following dates:

  • Class I: 1 July 2016.

  • Class II: 1 January 2016.

  • Class III: 1 July 2015.

  • Class IV: 1 January 2015.

More generally, the regulators have been increasingly tightening the regulation of medical products (both in terms of requirements and enforcement), especially in the areas of safety and advertisement. In this vein, the Park Geun-hye administration recently indicated its view that "adulterated foods" are among the "four evils" plaguing South Korean society and vowed to actively take measures to enhance food safety. This agenda is widely understood to cover safety issues regarding drugs, quasi-drugs, medical devices and cosmetics, as well as those specific to food products.

 

The regulatory authorities

Ministry of Food and Drug Safety (MFDS)

W www.mfds.go.kr/eng

Principal responsibilities. The MFDS is responsible for overseeing the manufacture, import, labelling and advertising, entry and exit inspection, and recall and destruction of medical products including drugs, biological products, medical devices and food products.

Ministry of Health and Welfare (MOHW)

W www.english.mw.go.kr

Principal responsibilities. The MOHW has overall responsibility for setting healthcare policy in South Korea and manages the sale and distribution of medical products. The MOHW works with HIRA and the NHIS regarding the pricing of medical products.

Health Insurance Review and Assessment Service (HIRA)

W www.hira.or.kr/eng

Principal responsibilities. HIRA reviews medical care benefits claimed by medical care institutions and assesses the reasonableness of those benefits.

National Health Insurance Service (NHIS)

W www.nhis.or.kr/static/html/wbd/g/a/wbdga0101.html

Principal responsibilities. Under the supervision of the MOHW, the NHIS evaluates the eligibility of the insured in the national health insurance scheme, imposes and collects contributions, and pays medical expenses.

Korea Fair Trade Commission (KFTC)

W www.nhis.or.kr/static/html/wbd/g/a/wbdga0101.html

Principal responsibilities. The KFTC is the Korean competition authority and regulates manufacturers, importers and distributors of medical products regarding matters including unfair sales practices and improper advertisements.



Online resources

Statutes of the Republic of Korea

W http://elaw.klri.re.kr ( www.practicallaw.com/4-522-4804) (click on the "English" button at the top right hand corner)

Description. Created by the government-sponsored Korea Legislation Research Institute (KLRI), this website contains English translations of most of the key laws in South Korea. The translations are not official versions and tend to be out-of-date, but can serve as a useful point of reference. Only Korean versions of statutes are binding.



Contributor profiles

Hwa Soo Chung, Senior Foreign Attorney

Kim & Chang

T +82 2 3703 1110
F +82 2 737 9091/9092
E hschung@kimchang.com
W www.kimchang.com

Professional qualifications. California, admitted to the Bar, 1993

Areas of practice. Health; anti-trust and competition; mergers and acquisitions; foreign direct investment; corporate governance; European and French law.

Non-professional qualifications. JD, University of California, Hastings College of the Law, 1992; MPA, Princeton University, 1982; AB, Harvard College, 1980

Languages. English, Korean, French

Publications.

  • Getting The Deal Through - Pharmaceutical Antitrust: "Korea" chapter (Co-author, Law Business Research, 2008-2015).

  • "Korea's Domestic Trade Politics and the Uruguay Round", in Domestic Trade Politics and the Uruguay Round (Co-author, Columbia University Press, 1989).

  • The Multifibre Arrangement in Theory and Practice (Co-author, Frances Pinter Publishers, 1985).

Kyungsun Kyle Choi, Senior Foreign Attorney

Kim & Chang

T +82 2 3703 1119
F +82 2 737 9091/9092
E gschoi@kimchang.com
W www.kimchang.com

Professional qualifications. California, admitted to the Bar, 1995

Areas of practice. Environment; product liability and consumer claims; mergers and acquisitions; foreign direct investment; health; corporate governance; German and European law.

Non-professional qualifications. JD, University of California, Hastings College of Law, 1994; AB, Occidental College, 1986

Languages. English, Korean

Publications.

  • Getting the Deal Through - Pharmaceutical Antitrust: "Korea" chapter (Co-author, Law Business Research, 2013-2015).

  • Getting The Deal Through - Anti-Corruption Regulation: "Korea" chapter (Co-author, Law Business Research, 2009-2015).


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