MEDICAL DEVICES CONTROL SYSTEM IN INDONESIA

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Presentation transcript:

MEDICAL DEVICES CONTROL SYSTEM IN INDONESIA MINISTRY OF HEALTH OF RI DECEMBER 2006

Basic Regulation 1. Law of the Republik Indonesia in 1992 regarding health 2. Government regulation no. 72 in 1998, regarding the safety of pharmacetical preparation and medical devices 3. Ministerial regulation of Health of RI no 1184/Menkes/Per/X/2004, regarding medical devices and household safety.

Medical Devices Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material on other similar or related article : a. intended by the manufacturer to be uses alone or in combination, for human being for one or more of the spesific purpose of. - Diagnosis, prevention, monitoring, treatment on alleviation of disease - Diagnosis, monitoring, treatment, alleviation or compensation for injury - Investigation, replacement or modification of the anatomy on of a physiological process

Medical devices…. continue - Supporting or sustaining life - Control of conception - disinfection of medical devices - providing information for medical or diagnostic purpose by means of in vitro examination of specimens derived from the human body

Medical devices…. continue And b. which does not achieve its principal intended action in or on the human body. By pharmacological, imonological or metabolic means, but which may be assisted in its function by such means.

MEDICAL DEVICE CLASIFICATION REGULATORY REQUIREMENT III II B II A I Device classes (risk based)

Scope of Medical Devices Control System Production Conformity assesment (registration) Distribution Market User 1 5 3 4 2

Production Production certificate issues by MOH Base on : Medical Devices GMP (Ref ISO 13485) Assessor : - Regulator : center and province Health officer We recognize what CAB done for production certificate

Distribution Distribution licence issued by MOH. Point to access : Who distribute (letter of Appointment) Infra structure Documentation Note : Distributor should be a sole agent principal for certain product

Confirmity Assesment ( Regulation ) Applicant should have : - Import : Distribution licence - Local : Production licence Submitted registration form

REGISTRATION PROCEDURE Expert Team Applicant Administration Check Scientific Evaluation Final Decision yes yes No Registration Number No

Matriks of registration requirement for medical devices base on medical devices clasification Class I Class II (A&B) Class III Form A : Administration data Letter of authorization as a sole agent by principal Certificate of production Distribution licence any administration doc. Such as : Tax no Location Letter of authorization as a sole agent by principall location

Registration Requirment ( continue ) Form Class I Class II (A&B) Class III Form B : Post Market requirement Procedure, record sys, complaint handling Procedure, record sys, complaint handling adverse affect report and recall system Procedure, record sys, complaint handling, adverse affect report and recall system

Form Class I Class II (A&B) Class III Form C : Product Information Objective and instruction for use Product information. Brochure/ leaflet component /formula qualitative labeling Indication control indication warning attention product description component /formula qualitative/ quantitative - Potential adverse effect - Raw material and packaging

Form Class I Class II (A&B) Class III Form D : Conformity Statement - Statement about conformity to standard safety – requirement and quality system Certificate or document about : Quality and Safety requirement ( COA finish product, etc. ) Quality system Product standard Quality plan production process From E : Distribution status C F S Summary of the problem has been recorded

Form Class I Class II (A&B) Class III Form F : Product Safety data none Summary of safety and effectiveness study (II B) Sterilization method summary of safety and efficacy study References Risk assessment Risk analysis evaluation measurement Summary of safety and efficacy study Pre clinic test clinical test validation summary of study From G : Clinical Data Scientific references result of clinical study

Post market surveylance Monitoring Sampling PMS is carried out by MOH (Province Health Officer) Manufacturer in order to warranty of their product

Thank you ...