- 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,
● Rule 1 ~ 4: NON INVASIVE DEVICES
● Rule 5 ~ 8: INVASIVE DEVICES
● Rule 9 ~ 12: ACTIVE DEVICES
● Rul3 13 ~ 18: SPECIAL RULES
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
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
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)
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)
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)
A device is:
"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is :
Applicable Products
The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892.
Conformity Assessment Procedure
FDA is US Market : If you are looking for a way to get into Korean medical device & OTC market, we are ready to help.
Conformity assessment procedure
Medical device registration procedure of SFDA is as follows:
The classification rule can be referred to www.sfda.gov.cn
Procedure:
Conformity assessment procedure
The method to get CCC certificate is as follows: Company shall first submit application, Technical files and testing sampling to CCC certification body, and the test must be performed in the testing institute designated by CCC. If the test has been passed, CCC will perform field auditing.
The certificate will be issued when the auditing result is positive, then company attaches CCC marking to the product and put into market.
Procedure
SFDA is Chinese Market : If you are looking for a way to get into Korean medical device & OTC market, we are ready to help.
Most of medical devices and product with the following intention and purpose of use is included.
Instrument, apparatus, appliance, material or other article, whether used alone or in combination, including software, intended by the manufacturer to be used for human beings, and of which purpose for use is not on the human body by pharmacological, immunological or metabolic means, but which may be assisted its function by such means
Classification
In accordance with the level of potential hazard on the human body, medical devices are classified into the following four classes by the medical device committee. If a given device can be classified into more than one class, then the highest possible class applies.
Conformity Assessment Procedure
Manufacturers and importers of medical devices should follow the below procedure for conformity assessment depending on the class of the product
Applicable Products
Conformity Assessment Procedure
KFDA is Korean Market : If you are looking for a way to get into Korean medical device & OTC market, we are ready to help.
Conformity assessment procedure.
To sale medical devices should obtain accreditation of foreign manufacturers and approval of foreign manufacturers. Class I products : submit a notice (medical devices manufacture and sale approval) Class II, III, IV products
Levels Classification Depend on risk elements Regulation Procedure *In case of Class III and IV should approval from MHLW and Class I,II can be approved from Notified body which are accreditated by MHLW. In this case, products are applicable to medical devices which standard of JIS and notification restrictively (medical devices which are not yet established JIS standard among classified as Class II should be approved by MHLW)
New approved OTC
The followings are approved by MHLW
Conformity assessment procedure
To sale and manufacture OTC need to accreditation of foreign manufacturer and approval of foreign manufacturer
MHLW is Japanese Market : If you are looking for a way to get into Korean medical device & OTC market, we are ready to help.