General Description

The Medical Devices Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied.

Applicable Products

Almost medical devices are applied to Medical Device Directive. Applied products are following: ‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means

Conformity Assessment Procedure

○ Classification
Annex IX of Medical Device Directive (93/42/EEC) provides 18 rules to classify medical devices. According to Rules, medical devices are classified by intended purpose.

● Rule 1 ~ 4: NON INVASIVE DEVICES
● Rule 5 ~ 8: INVASIVE DEVICES
● Rule 9 ~ 12: ACTIVE DEVICES
● Rul3 13 ~ 18: SPECIAL RULES

Risk value of medical devices for patient or user is confirmed and classified in accordance with those 18 rules. Depends on the confirmed risk value, conformity assessment process is decided. If risk level is higher and higher, conformity assessment requirements was more and more strictly.
Medical devices were classified in accordance with above 18 rules such as I, I-measuring, I-sterilization, IIa, IIb and III.

1. Class I medical devices follows Annex VII.
2. Procedure of Class I (with measuring function)

o Manufacturer´s possibility to choose:
o Technical documentation according to Sec. 3 of Annex VII and verification of the conformity with metrological requirements on each piece or on a statistically selected sample according to Annex IV
o Annex VII technical documentation according to Sec. 3 and assessment of production quality system according to Annex V related to metrological requirements
o Annex VII technical documentation according to Sec. 3 and quality assessment of MD according to Annex VI related to metrological requirements

3. Procedure of Class I (with sterile)

o Manufacturer proceeds as follows:
o Technical documentation according to Sec. 3 Annex VII and assessment of production quality system according to Annex V related to sterile conditions

4. Procedure of Class IIa medical devices

o Manufacturer´s possibility to choose:
o Technical documentation according to Sec. 3 of Annex VII and verification of the conformity with the technical documentation on each piece or on a statistically selected sample according to Sec. 8 of Annex IV
o Technical documentation according to Sec. 3 of Annex VII and assessment of production quality system according to Sec. 6 of Annex V (by an audit at the manufacturer's sites)
o Technical documentation according to Sec. 3 of Annex VII and assessment of medical device quality according to Sec. 6 of Annex VI (by an audit at the manufacturer's sites)
o Technical documentation according to Sec. 3 of Annex VII and assessment of full quality system by an audit at the manufacturer's sites according to Annex II (except design examination according to Sec. 4)

5. Procedure of Class IIb medical devices

o Manufacturer´s possibility to choose:
o Technical documentation according to Section 3 of Annex III, examination of type and verification of conformity of each piece manufactured; the verification is done according to Section 5 or on a statistically (randomly) selected sample according to Section 6 of Annex IV
o Technical documentation according to Section 3 of Annex III, examination of type and assessment of production quality system according to Annex V (by an audit of the manufacturer's sites)
o Technical documentation according to Section 3 of Annex III, examination of type and assessment of medical device quality according to Section 6 of Annex VI (by an audit at the manufacturer's sites)
o Technical documentation according to Section 3.2 of Annex II and assessment of full quality system by an audit at the manufacturer's sites according to Annex II (except design examination according to Section 4)

6. Procedure of Class III medical devices

o Manufacturer´s possibility to choose: o Technical documentation according to Section 3.2 of Annex II, description of the design according to Section 4.2 and assessment of full quality system according to Annex II (by an audit at the manufacturer's sites) o Technical documentation according to Section 3 of Annex III, examination of type and verification of conformity of each piece produced; the verification is done according to Section 5 or on a statistically (randomly) selected sample according to Section 6 of Annex IV o Technical documentation according to Section 3 of Annex III and Section 3.2 of Annex V, examination of type and assessment of production quality system (by an audit of the manufacturer's sites)

General Description

•    • Medical device is defined in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act. It includes not only the end product but also accessories and components.
•    • Section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act

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•    • Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
•    • Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
•    • Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

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•    • Medical devices are classified according to risk which the device poses to the patient. According to kinds of product and class, conformity assessment procedure are Registration, 510(k)(premarket Notification & Special Control) and PMA (Premarket Approval).
•    • FDA applies one of 3 class based on the necessary regulation to check safety and effectiveness.
•    • In addition, classification is risk based, that is, the risk the device poses to the patient and/or the user is a major factor in the class it is assigned. Class I includes devices with the lowest risk and Class III includes those with the greatest risk.

•    • Classification
•              ° Class I, Devices
•                      • Class I means the class of devices that are subject to only the general controls.
•                      • Product type: Bandage, surgical gloves, surgical knife, surgical brush.
•              ° Class Ⅱ, Devices
•                      • Class II means the class of devices that is or eventually will be subject to special controls.
•                      • Product type: Condoms, Contact lenses, Infusion pump, Bone powder, Dental material.
•              ° Class Ⅲ Devices Class III means the class of devices for which premarket approval is or will be required in accordance with section 515 of the act.
•    • How to register Medical device (510k)
•              ° (Premarket Notification, 510(k))
•              ° Applied to Class I, II medical devices
•              ° Class I medical devices is 510 k exempt but some of class I medical devices and class II medical devices should submit premarket notification to FDA.
•              ° Lists of Premarket Notification are registration of facility, badness.
•                      • Audit Period: 90 days – 180 days (Sometimes, It takes 1 year)
•                      • Contents of Premarket Notification:
•                      • Writing name of applicant, address of applicant, Manufacturer, address of sterilization facility, registration number and application date.
•                      • Explanation of product: name of product, classification, appearance and structure, intended use, principle of operation, labeling and performance standard
•                      • Substantial Equivalent data: Test report, Test report about performance and biocompatibility
•    • Premarket Approval application: (PMA)
•              ° Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
•              ° Contents of Premarket Approval application
•                      • Test method, test report, document of safety and effectiveness
•                      • It is compulsory to apply general regulation of registration, badness etc. GMP audit is also compulsory. Audit of safety and effectiveness is added.
•              ° 4 step audit
•                      • Filing Review
•                      • In-depth Review
•                      • Panel Review
•                      • Notification of final discussion and FDA approval
•              ° Other requirements
•                      • Preclinical laboratory testing data
•                      • Animal testing data
•                      • Human clinical testing data
•                      • Good Manufacturing Practices
•    • Medical device requirements
•              ° Registration of Manufacturing Establishment
•              ° Listing of all Devices Manufacturing
•              ° Record Keeping & Reporting by the Manufacturer
•              ° Limitation Regulation of medical device use
•              ° Regulation of making labeling
•              ° Regulation of refund and repair of medical device
•              ° Registration of medical device and facility every year
•    • Surveillance audit FDA audit approved medical device once a 2 year for surveillance control. After FDA determination of audit, FDA performs audit according to GMP regulation.

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General Description
In order to enhance the supervision of Medical device and ensure its safety, efficiency and human health according to Regulations on Supervision and Management to Medical device (No. 276, State Council of the People's Republic of China), SFDA accepts the sales of Medical device either manufactured in domestic market or imported from abroad by obtaining SFDA medical device registration compulsively.

Applicable product
SFDA Medical Device definition:
Any instrument, apparatus, implement, material or other article, including software, intended to be used, alone or in combination, for human beings for the purpose of : -prevention, diagnosis, treatment, monitoring or alleviation -diagnosis, treatment, monitoring, alleviation of or compensation for an injury or handicapped -investigation, replacement or modification, or support of the anatomy or of a physiological process -control of conception And which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in this function by such means.

Classification
Medical device is classified according to the classification regulation (regulation No.15). The classification is decided according to the trait of the stucture, the usage form and the usage pattern of the medical devices. The specific classification is as follows: Class I: Medical devices which meet the safety and validity requirements of the general regulation
Class II: Medical devices of which the safety and validity should be controlled
Class III:

1. Impant medical devices.
2. Medical devices which maintain and support the life.
3. Medical devices of which the safety and validity need to be controlled strictly because of their potential risk to human body.

1. Classification;
2. product testing;
3. product registration (when testing result is passed).
4. certificate issuing.

1. Classification of Medical device
   Medical device is classified on the basis of technic, structure, performance, guideline and usage. It can be classified as Class I, Class II, Class III according to the product risk. Class I product has the lowest risk and Class III has the highest risk.
2. Testing process of medical device
1. Application for the product registration standard（in Chinese）
2. Reviewing the product registration standard
3. Application for the Type Examination in China（Domestic medical device / Imported medical device – belong to Class II, Class III）
4. Type Examination
   When applying for registration of Class II and Class III medical device, the product test must be performed in the testing institute accredited by SFDA.
5. Clinical trials（Imported medical device- Class Ⅲ Implantable medical device） There’s no “Exempt” of clinical trials for Class III medical device. Clinical trials shall be performed according to Annex 12 of (Registration Management Method of Medical Device), requirement of (Clinical Trials Data Classification Rule of Medical Device Registration), product Classification and the practical situation of manufacturer.
3. Registration process of Medical device
1. Submitting registration files（the registration can be started when obtaining test report and clinical test report (if applicable)）
2. Document reviewing and evaluation（Test report and related documents reviewing）
3. Admin checking and approval（Approval after checking the application data, test report and clinical test report conform to related regulation）
4. Registration certificate issuing (Issuing related Medical device registration certificate, and the certificate’s period of validity is 4 years.)

General Description
CCC is China Compulsory Certification for short. It is a compulsory certification system refers to the product and its attachment either manaufactured in domestic market or imported from abroad, which is listed in the Chinese compulsory table of contents can only be distributed in China by obtaining safety and quality approval of CCC according to IEC standard and China National Standard.

Applicable products
The certification scope of CCC can be divided into 20 categories and 135 items.

1. Cable and wire
2. Switches for circuits, installation protective or connection devices
3. Low Voltage electrical Apparatus
4. Fractional horse-power motors
5. Electric tools
6. Welding machine
7. Household and similar electrical applicances
8. Audio and video equipment（exclude broadcast and auto sound apparatus）
9. IT products
10. Lighting apparatus
11. Telecommunication terminal equipment
12. Motor vehicles and safety parts
13. Motor vehicle tyres
14. Safety glasses
15. Agricultural machine products
16. Latex and emulsion products
17. Medical devices
18. Fire protection service
19. Security and protection products
20. Solvent coatings The detailed information can be referred to: http://219.238.178.8/20040420/column/227.htm

General Description & Applicable Products
In accordance with Chapter I, Article 2 of the Medical Device Act, the term “medical device” means any instrument, apparatus, appliance, material or similar product, whether used alone or in combination, to be used for human beings or animals and product that belong to one of 1 to 4 below. However, it excludes pharmaceuticals and quasi drugs under the Pharmaceutical Affairs Act and, of rehabilitation aids, prosthetic limb/aid under the provisions of the Article 55 of the Welfare of Disabled Persons Act.

•    • Product used for the purpose of diagnosis, treatment, alleviation or prevention of disease
•    • Product used for the purpose of diagnosis, treatment, alleviation or compensation for an injury or handicap
•    • Product used for the purpose of investigation, replacement or modification of the anatomy or the physiology
•    • Product used for the purpose of the control of conception

•    • Medical instrument

•              ° Operating and treatment table, bed for medical use, medical sterilizing apparatus, medical water sterilizer, respiratory apparatus, medical chamber, artificial internal organ apparatus, neonatal incubator, medical x-ray system, non-ionization diagnostic device, radiologic device, film developer for medical use

•    • Medical Supplies

•              ° Knives for medical use, curettes, clamp, forceps, stethoscope, clinical thermometric system

•    • Dental Materials

•              ° Orthodontic materials, dental boding and filling materials, dental metals, prosthodontic materials

•    • Class 1 Medical device that either does not directly touch the human body or touches but there is almost no potential danger, and has minimal effect on the human body by malfunction or disorder

•    • Class 2 Medical device with low potential danger that, although there is a danger on the human body by malfunction or disorder during operation, there is little possibility of causing danger to life or encountering significant functional error

•    • Class 3 Medical device that is used as implanted inside the human body for a period of time or poses potentially high danger

•    • Class 4 Medical device that is permanently implanted inside the human body, directly touches the heart, central nervous system or central circulatory system, or uses tissues or derivatives of animal or raw material with insufficient information for the verification of its safety
  
  *** Classification site : http://md.kfda.go.kr/technical/technical_4.jsp

•    • Manufacturer
  
  For Class 1,
  Declare product -> File for manufacture license and declare product -> KGMP approval for manufacture and quality management -> Sell after manufacture
  
  For Class 2, 3 or 4,
  File for product license -> Request for safety and effectiveness inspection -> Inspection -> Request for the review of technical report -> File for manufacturer license & declare product -> KGMP approval for manufacture and quality management -> Sell after manufacture
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•    • Importer
  
  For Class 1,
  Declare product -> File for import license and declare importing product -> KGMP inspection for importation and quality management -> Customs clearance report -> Sell after customs clearance
  
  For Class 2, 3 or 4,
  Product license -> Request for safety and effectiveness inspection -> Test medical device confirmation -> Customs clearance report -> Import clearance -> Inspection -> Request for the review of technical document -> File for import license and declare importing product -> KGMP approval for import and quality management -> Customs clearance report -> Sell after clearance

General Description
The term “OTC” means

1. Article used for treatment, alleviation or prevention of disease of human being or animal and that is textile or rubber product or something similar
2. Article that has minimal effect on the human body or not directly affect the human body, and not an instrument or apparatus or something similar
3. Medicine used for sterilization or for similar purpose for the prevention of infectious disease

1. Hygiene products (textile, rubber or paper provided for hygienic use)
   1. Hygienic band: tampon
   2. Cover: mask, eye patch
   3. Wrapper: bandage, elastic bandage, plaster bandage, cylindrical elastic bandage
   4. Gauze, absorbent cotton
   5. Bandage or similar articles
2. OTC
   1. Antiperspirant
   2. Medicine for growth, dyeing and removal of hair
   3. Pesticide
   4. Contact lens caring kit
   5. Quit smoking kit
   6. Germicide
   7. Spray PAS only used for external application determined by the manufacturing standard for pharmaceuticals
   8. Of medicine for internal use
      •    • Low-content vitamin and mineral pill designated by manufacturing standard for pharmaceuticals, etc.
      •    • Liquid-type nutrient and tonic designated by manufacturing standard for pharmaceuticals, etc.
   9. Medicine for oral hygiene
   10. Insecticide, rodenticide
   11. Sterilizer-disinfectant not directly applied on the human body
       •    • Disinfectant made of alcohol, aldehyde, cresol
       •    • Medicine for communicable diseases control

1. Review of specifications and testing method: general review (59 days), modification review (32 days)
2. Review of safety and effectiveness: new drug review (60 days), review of submitted drug (45 days)
3. Product (modification) report (10 days)
4. Product approval (25 days), modification approval (10 days or 20 days)
5. Manufacture/Importer report and manufacturer license, business place, storage facility inspection (if the first time)

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General Description
Launching a sales medical devices should be met with Pharmaceutical Affairs Law’s approval in Japan.

Applicable products
According to Pharmaceutical Affairs Law annex 2 paragraph 4,medical devices are aim to diagnostic, Therapy and prevention of human or animals and aim to influence to function and anatomy of human or animals Base on Pharmaceutical Affairs Law annex 2 paragraph 2 to 7, medical devices are classified as revels of MHLW

•    • Class I: organism investigation devices, medical microscope, Diagnostic X-ray, blood investigation, nebulizer
•    • Class II: MRI, electrical blood pressure. Electrical endoscope, supersonic wave diagnosis, dental alloy.
•    • Class III: electronic surgical instruments, intra ocular lens, medical cautery, suture, dental excision, pulmonary pleura, artificial bone and joint
•    • Class IV: investigation devices for internal organs, medical blowpipe and body fluids, science diagnostic devices.
  

•    • accreditation of foreign manufacturers
  l Application of Medical devices manufacture approval

•                      • Clinical data needs : manufacture approval needs to Clinical data.
•                      • Need Approval standard and not require clinical data: manufacture approval application (not confirmed approval standard medical devices or not conformity to approval standarsds medical devices).limits it does not need clinical data.
•                      • Need Approval standard and not require clinical data: manufacture approval application for Medical device which have approval standards
•                      • Highly management devices approval and accreditation standard is Not: there is no approval standards and manufacture approval application of medical devices(not require clinical data)
•              ° Procedure of accreditation of foreign manufacturers
  foreign manufacturer approval application
  Gain manufacture Code No (locality government) --> foreign manufacturer approval application(PMDA) --> Approved
•                      • document investigation (GQP,GVP)
•                      • site investigation (document investigation if it is case of foreign manufacturer)

•    • foreign manufacture sale approval application - Technical fie and validation of products, audit of stability, GMP and PDMA In case of no comment, audit report and application be submitted to MHLW and approved from MHLW

General Description
OTC(Over The Counter) is middle classification between medicine and cosmetic and it influences to body lightly. OTC should be accredited or approved to sale in Japan, according to Pharmaceutical Affairs Law.

Applicable products

•    • Prevention retching, displeasure, body smell
•    • Prevention Prickly heat
•    • Prevention alopecia
•    • Prevention Rats, fly, insects for health
•    • Medical cosmetic, medical tooth paste, shampoo, lines content particular material.

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•    • Refreshing for throat
•    • Refreshing Improvement for Stomach function
•    • Vitamin, calcium
•    • Health tablet of vitamin It is confirmed in 1999 by MHLW(Ministry of Health, Labour and Welfare)

•    • foreign manufacturer approval application Gain Code No (locality government)  Approvedà foreign manufacturer approval application(PMDA)

•                                                       document investigation (GQP,GVP)
•                                                       site investigation (document investigation if it is case of foreign manufacturer)

•    • foreign manufacture sale approval application
               ° Technical fie and validation of products, audit of stability, GMP and PDMA In case of no comment, audit report and application be submitted to MHLW and approved from MHLW
  
  

  MHLW is Japanese Market : If you are looking for a way to get into Korean medical device & OTC market, we are ready to help.