Healthcare Quality Requirements

Transcription

1 Healthcare Quality Requirements 1

2 Regional Healthcare Regulatory Agencies Country Local Regulatory Agency Singapore Health Sciences Authority Thailand Thailand Food and Drug Administration (TFDA) Medical Device Control Division Malaysia National Pharmaceutical Control Bureau Ministry of Health Malaysia Regulation of Medical Devices in Malaysia Indonesia National Agency of Drug and Food Control of the Republic of Indonesia Medical Device Regulation Philippines Food and Drug Administration (FDA) of the Republic of the Philippines Vietnam Ministry of Health Department of Medical Equipment and Health Works (DMEHW) Ministry of Science and Technology India Central Drugs Standard Control Organization Australia Therapeutic Goods Administration (TGA) 2

3 Local Quality Requirements Summary Country Registration of Distributors and Importers Required Procedures Singapore Yes Distribution Records Complaint Records Report Adverse Events Notify the Authority of Field Safety Corrective Action Thailand For Licensed Medical Device only Malaysia Voluntary Distribution Records Complaint Handling Adverse Incident Reporting Field Safety Corrective Action Local Quality Requirements for Importers and Distributors Good Distribution Practice for Pharma Good Distribution Practice for Medical Device TBD Good Distribution Practice for Pharma Medical Device Control Division License in compliance with the Thai Industrial Standards Institute s standards which are based on ISO standards Good Distribution Practice for Pharma Good Distribution Practice for Medical Device Yusen Existing Quality Standard GDPMDS ISO 9001 GDPMDS Indonesia Yes TBD Good Distribution Practice for Pharma Good Distribution Practice for Medical Device GDPMDS Philippines Yes TBD Good Distribution Practice and Good Storage ISO 9001 Practice for Pharma Vietnam Yes TBD Good Distribution Practice and Good Storage ISO 9001 Practice for Pharma India Yes TBD Good Distribution Practice for Pharma ISO

4 Local Quality Requirement per Country SINGAPORE Companies importing medical devices and pharmaceutical products in Singapore have to apply for an importer's license and are required to comply with the Good Distribution Practices to ensure that products are consistently stored and handles under defined conditions as stipulated by the product registration or product specifications. Certification to ISO or GDPMDS is not performed by the HSA, but by certification bodies which are accredited by the Singapore Accreditation Council. Singapore is the first country among the ASEAN members to implement medical device regulations according to the AMDD and based on this, in line with most of the GHTF requirements. THAILAND Importing medical devices, pharmaceuticals, food supplements, products for animal health, or other medical substances into Thailand requires registration with the Food and Drug Administration of Thailand (FDA). Thailand has its own medical device regulation since 1988 in the form of the Medical Devise Act. The agency regulating devices in Thailand is the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (TFDA). The MDCD is responsible for the licensing manufacturers, importers and distributors of medical devices. 4

5 Local Quality Requirement per Country MALAYSIA Importers and wholesalers of registered products shall adhere to Good Distribution Practice (GDP) requirements. GDPMD is a requirement for establishment licensing of distributor, Authorized Representative (AR) and importer. It is a type of QMS to ensure the safety and performance throughout the medical device supply chain. The GDPMD will be assessed and certified by the Conformity Assessment Body (CAB) shall be submitted to MDA as part of the requirements for establishment license application. INDONESIA Decree of the Head of NADFC No. HK on Implementation of Good Distribution Practices mentions that Wholesalers and all parties involved in distribution of medicines have the obligation to comply with Good Distribution Practices (GDP)in all aspects. A company which has a distribution license issued by Ministry of Health (MOH) can distribute medical device in Indonesia. A routine assessment is being carried out by MOH to ensure distributor companies adhere to GDP requirements. 5

6 Local Quality Requirement per Country VIETNAM In Vietnam, pharmaceutical importers have to comply with Good Storage Practice (GSP) while distributors with GSP and Good Distribution Practice (GDP) The Vietnamese government issued Decree No. 36/2016/ND-CP on the management of medical devices (Decree 36). This decree took effect on July 1, bringing medical devices under uniform management. Previously, there were two separate systems of legislation one for medical devices manufactured domestically and the other for imported medical devices. All domestically manufactured medical devices had to be registered and granted marketing authorization licenses (MA licenses) from the Department of Medical Equipment and Health Works (DMEHW) under the Ministry of Health before being circulated. Foreign medical devices, on the other hand, did not require registration but had to obtain import licenses from the DMEHW to be imported and circulated in Vietnam 6

7 Local Quality Requirement per Country PHILIPPINES Administrative order : Adoption and implementation of the World Health Organization Annex 5 Guide to Good Distribution Practices (GDP) for Pharmaceutical Products, and Annex 9 Guide to Good Storage Practices for Pharmaceuticals The principal medical device regulatory authority in the Philippines is the Bureau of Food and Drug Administration (BFAD), under the auspices of the Department of Health (DOH). Importation of medical devices does not require prior approval of BFAD or the Bureau of Product Services, unlike drugs, food supplements and disposables. In addition, there are no import quotas for this sector, including used and refurbished medical equipment INDIA Each activity in the distribution of pharmaceutical products in India needs to be carried out according to the principles of Good Distribution Practice (GDP). Presently, the Indian market for medical devices is largely unregulated. Medical devices are freely imported into India. The authority regulating medical devices will be the Central Drug Standard Council Organization (CDSCO) in the Ministry of Health. Currently, CDSCO s functions are to establish the standards and regulations for drugs, blood and blood products, intravenous fluids, and vaccines. With added responsibility of regulating the medical devices industry, CDSCO will be the approving authority for import, manufacture and sale of medical devices in India.. 7

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