Overview of medical and healthcare devices industry in Indonesia

Indonesia is known as the fourth most populous country in the world, with a population of more than 240 millions, where the market for medical supplies was valued at US$593.8 million in 2013 and imports supply an estimated 97.2%. It remains one of the fastest growing markets worldwide with growth at 12.7% per annum on average. The Indonesian medical device market, in US dollar terms, is projected to rise by a CAGR of 12.7%, which should bring it from an estimated USD672.8mn in 2013 to USD1,221.9mn in 2018. Indonesia's projected 2013-2018 CAGR ranks it amongst the top 15 fastest growing markets in the world. By individual product area, the CAGRs are expected to range from 20.3% for diagnostic imaging to 5.9% for other medical devices.

The market heavily relies on foreign imports of medical devices because of the lack of established local manufacturers. Local manufacturers only produce primary medical products, for instance, surgical gloves, bandages, orthopedic aids and hospital furniture. For medical consumable products, they constitute the largest class of medical import. . In US dollar terms, imports grew by 8.4% in 2013 to reach USD647.0mn in 2013.

Survey on Medical and Healthcare Devices industry

in Indonesia

IntroductionHong Kong Pavilion was set up in one of the most popular exhibitions in Indonesia, the 27th Indonesian Int'l Hospital Medical Pharmaceutical Laboratories Equipment & Medicine – Hospital Expo 2014, and survey was conducted on-site among visitors and potential business partners to learn about the local market and their business considerations in partnership with foreign manufacturers. Brief review of the show and visitors profile are as below.

Survey Results

1. Sales volume amount (USD/Year)

17% of the respondents have a sales volume over $2,000,000 and $50,000 - $100,000 respectively. It follows by $500,000 – $2,000,000 which constitutes 14%, and $100,000 – $200,000 consists of 11%. The remaining 12% was evenly shared by <$50,000 and $200,000 – $500,000.

<$50,0008%

$50,000-$100,00024%

$100,000-$200,000

16%$200,000-$500,000

8%

$500,000-$2,000,000

20%

>$2,000,00024%

Sales Volume Amount (USD/Year)

<$50,000

$50,000-$100,000

$100,000-$200,000

$200,000-$500,000

$500,000-$2,000,000

>$2,000,000

2. Products respondents are interested

Healthcare product is the most popular product (28%), and follows by hospital Infrastructure (26%) and disposables (16%). Popularity for instrumentation and IVD are the same (6%), and so are dental, minimal invasive surgery and oxygen supply system (4%).

Dental 4% Instrumentation

6%

Oxygen supply system4%

Minimal Invasive surgery4%

Hospital Infrastructure28%

Disposables17%

IVD6%

Healthcare product30%

products respondents are interested

3. Contact points in Hong Kong/China

Two-fifth (40%) of the respondents have contact points in Hong Kong or China, while 57% of them do not.

Yes 41%

No 59%

contact points in Hong Kong/China

4. Priority of factors on purchasing.

Price (27%) tops the priority of all six factors and closely followed by quality (26%). The third factor is customer relationship, it consists of 15%. The last two factors constitute the same percentage (9%), which are branding and certification.

Branding10%

Price 28%

Functional-ity

10%Certification11%

Customer relation-

ship16%

Quality27%

Priority on factors of purchasing

5. Countries of distribution

The products are mostly distributed within Indonesia (22%), and then Vietnam (7%). The third place are equally shared by Thailand, Malaysia and Philippines, each composes 5%. Cambodia is also on list which comprises 2%. Approximately one-tenth (12%) of the respondents distribute their products to other countries, such as Belgium America and China.

Indonesia 38%

Thailand 8%

Malaysia 8%

Philippines8%

Vietnam13%

Cambodia4%

Others21%

Countries of distribution

Indonesia

Thailand

Malaysia

Philippines

Singapore

Vietnam

Lao

Cambodia

Others

Gap assessment checklist for enterprises to self-evaluate to enter the Indonesian Medical and Healthcare Device market.

Basic informationCapital JakartaOfficial Language IndonesianReligion Islam

ProtestantismCatholicism

Population 255,461,700 (2015 estimate)GDP (Purchasing Power Parity) $2.554 trillionTime zone (UTC+7 to +9)Currency Indonesian rupiah (Rp) (IDR)

1 HKD = 1,600 IDR (avg. on Mar 2015, for reference only)

Calling code +62Internet TLD .idMedical Device Regulation requirementRegulated Department Minister of Health

http://www.depkes.go.id/index.phpWhat is your device category Medical device;

Household products (Healthcare product)

What licenses are you going to apply?

Production license (All medical and healthcare device manufacturer located in Indonesia require to possess production licence)

Marketing license

Distribution license

Your device classification http://www.depkes.go.id/index.php?act=regulation

Medical Device: Class 1

Medical Device: Class 2a

Medical Device: Class 2b

Medical Device: Class 3

Healthcare product: Class1 (low risk)

Healthcare product: Class2 (medium risk)

Healthcare product: Class3 (high risk)

You must have a sole agent in Indonesia with Good Distributor Practise “GDP”

You need to have a Medical Device Distributor (Importer) to support your application in applying marketing license

All labelling is written in Indonesian

The imported device have “CE mark” (CE mark is a plus, not a must)

You need to provide Technical File or Design Dossier or manufacturing dossier which are ready for submission (For example, certificate of the standard, clinical evaluation report and quality system…etc.)

You need to have conformity evidence to such standard. (eg. CoC certificate of conformity.

You need to possess ISO 13485 or related QMS such as GMP

You must have the equivalent of certificate of free sales from the authorized institution

You need to provide marketing history of the product

You need to have the design verification and validation document

You need to have the risk analysis report

You need to have the specification of packaging

Result of the analysis test or results of the clinical test and safety and efficacy of the medical devices

Post market surveillance procedure (Normally prepared by your designated importer)

Note:Processing time:Class I: 45daysClass II: 90daysClass III: 120days

Gap assessment checklist for enterprises to self-evaluate to enter the Russian Medical and Healthcare Device market.

Basic informationCapital MoscowOfficial Language RussianReligion Russian Orthodox (41%)

Non-religious (13%)Muslim (6.5%)Others

Population 143,975,923 (2015 estimate) source: Federal State Statistical Service. Retrieved 8 April 2015.

GDP (Purchasing Power Parity)

$3.458 trillion

Time zone (UTC+2 to +12)Currency Russian ruble (RUB)Calling code +7Internet TLD .ru

.su

.рфMedical Device Regulation requirementRegulated Department

The Federal Service for Control over Healthcare and Social Development (Roszdravnadzor). It governs and controls the registration procedure, approves or rejects applications for state registration, and works to ensure clinical safety and efficiency of medical devices and medical equipment.http://www.roszdravnadzor.ru/

Federal Agency for Technical Regulation and Metrology (Gosstandart), this agency makes sure that medical equipment imported into Russia meets established Russian standards. This agency is responsible for GOST-R certificationhttp://www.gost.ru/wps/portal/pages.en.Main

Federal Service for Supervision in the Area of Consumer Rights and Welfare Protection (Rospotrebnadzor). This agency makes sure that products meet Russia’s sanitary and epidemiological regulations for products that come into contact with the human body or which may otherwise negatively affect patients or doctors. They issue Sanitary-Epidemiological Conclusion (Hygiene Certificate).http://rospotrebnadzor.ru/about/info/news/

Your device classification

Medical Device: Class I

Medical Device: Class IIa

Medical Device: Class IIb

Medical Device: Class III

Appoint an Authorized Representative to coordinate your medical device registration in Russia and your Import Permit Application.

You have checked if there is an already approved and equivalent device exits in the Russian Federation

You have confirm your device classification

Meet with officials to determine the testing requirements for your product.

Submit technical documentation to authorized testing centers to determine applicable in-country testing. Documents must be in Russian.(Note: medical devices must have testing conducted in Russia even if the equivalent testing has been performed to international standards outside of Russia.)

RZN approves Import Permit Application to import testing samples of your device.

Conduct testing at government authorised testing and medical centres within Russia.

Receive results of testing and medical reports.

Prepare the registration dossier, including testing results and medical reports.

Submit all documents to the relevant officials and receive a Registration Certificate.(Remark: all documents and information for registration of a medical product must be provided in Russian. Official documents such as a Power of Attorney, Certificate of Free Sale, Certificate to Foreign Government, Certificate of

Incorporation, ISO certificates and others must have a Notary stamp and corresponding Apostille (i.e. legalisation). The original documents must be provided with a notarised document translated into Russian.)RZN, along with their Expertise Center will review your Registration Dossier and determine if the documentation is sufficient to proceed to clinical trials.

Work with a medical institution authorized by RZN to conduct clinical trials. Once the results of clinical trials are obtained, your Authorized Representative will submit the results to RZN and the Expertise Center and apply for continuation of the registration process.

Apply for a Hygiene Certificate (if applicable to your product) to Rospotrebnadzor.

Apply for GOST–R Certificate to Gosstandart.

Product is added to Roszdravnadzor database, which is published on their website.

Appoint a Russian Declarant and apply for Declaration of Conformity (DoC) certification. DoC certification is a combined quality and product safety certificate.Documents needed include Registration certificate, test reports, proof of QMS compliance such as ISO 13485 certificate, and other documents.

After DoC certificate has been issued, the DoC symbol must be placed on your device.

Device can be imported into the Russian Federation upon presentation of Registration, Hygiene (if needed) and GOST-R Certificates, plus other typical international commercial shipping documents (e.g. a Cargo Customs Declaration and a Declaration of Conformity with Russian standards and regulations).

Note:Processing time:Class I, IIa, IIb, III: 20 weeks

Source: Emergogroup

Gap assessment checklist for enterprises to self-evaluate to enter the Brazilian Medical and Healthcare Device market.

Basic informationCapital BrasíliaOfficial Language Portuguese

LibrasReligion Roman Catholic (64.63%)Population 202,768,562 (2014 estimate)GDP (Purchasing Power Parity) $3.259 trillion (2015 estimate)Time zone (UTC -2 to -5)Currency Real (R$) (BRL)Calling code +55Internet TLD .brMedical Device Regulation requirementRegulated Department Agência Nacional de Vigilância Sanitária

(ANVISA)http://portal.anvisa.gov.br/wps/portal/anvisa/home

Your device classification Medical Device: Class I and IICadastro

Medical Device: Class I and IIRegistro

Medical Device: Class IIIRegistro

Medical Device: Class IVRegistro

Appoint a company that holds a Company Working Allowance permit from ANVISA as your Brazil Registration Holder (BRH). Foreign manufacturers do not need to obtain this permit unless they plan on importing and distributing their own products in Brazil.

Provide Letter of Authorization to your BRH, who will submit your registration application and Technical File to ANVISA.Your BRH maintains control of your device registration and Brazil Good Manufacturing Practice (BGMP) certification (if applicable).

Certain devices require INMETRO Certification. Testing for electro-medical products performed outside Brazil is usually accepted if performed by an ILAC-certified lab. (CB Scheme is not accepted). Compile tests and pay fee to INMETRO Certifier. INMETRO certification is valid for 5 years, and annual audits and fees are required.

Class I and II device manufacturers (both cadastro and registro) must comply with BGMP requirements. (ANVISA will not conduct an audit.) Class III and IV device manufacturers must be audited for BGMP compliance by ANVISA, as found in RDC 16/2013. BGMP fees are due every two years.

Class I and II cadastro devices prepare abbreviated application. Send legal documents, as well as proposed labeling and IFU to BRH to keep on file in case of later ANVISA audit. Class I through IV registro prepare Technical File which includes clinical data, clinical studies (if applicable), information on your device in accordance with Annex III, Part A, B, and C in RDC 185/2001, as well as proposed labeling and instructions for use found in Annex III Part B.

For all devices, there are three possibile ways to satisfy the following requriement: 1) Obtain a Certificate of Free Sale (CFS) or device registration certificate proving home-country approval from your Ministry of Health; 2) Show proof of registration in two other markets and provide reason your device does not have home-country approval; 3) INMETRO certificate for applicable devices.

For Class I and II cadastro devices, your BRH submits the abbreviated application to ANVISA. For Classes I through IV registro devices your BRH submits full application, which includes the technical file, to ANVISA. For both cadastro and registro pay the application fee. The documents must be submitted in Brazilian Portuguese.

For all classes, ANVISA reviews registration application. If approved, ANVISA will

publish registration number in the Diário Oficial da União (DOU). Registrations are valid for 5 years. Registration renewals must be initiated one year prior to expiration.Appoint a qualified importer/distributor to bring your device into Brazil. You may now begin marketing your device in Brazil.

Note:Some devices listed in RDC 3385/2006 require an Economic Information Report (EIR) compliant with RDC 185/2006 be submitted to NUREM, a division of ANVISA, with the application or within 30 days after its approval. This report includes pricing comparisons for other markets, patient/user information, and marketing materials.

Processing time:Class I: 45daysClass II: 90daysClass III: 120days